Overweight and ObesityPhase 4NCT04614233
Targeting the Gut-brain Axis to Facilitate Weight Loss in High Fat Diet Consumers
A Phase 4 study testing RiduZone (90% OEA) in people with Overweight and Obesity, run by Yale University at 1 site in United States.
Trial summary
The primary objective is to test if fat intake moderates the ability of oleoylethanolamide (OEA) to improve weight loss maintenance after the LEARN® weight loss program. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Overweight and Obesity
- What is being tested?
- RiduZone (90% OEA)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Apr 2021to 4 Oct 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Ages 18-55
- Right-handed with a score of ≥ +50 on the modified Edinburgh handedness scale
- English-speaking
- BMI > 25.0
- Comfortable with the fMRI procedures during the mock scanning session and rate milkshake as at least mildly liked
Who cannot join
- Serious or unstable medical illness (e.g., cancer)
- Past or current history of alcoholism or consistent drug use
- Current major psychiatric illness as defined by DSM-IV criteria including eating disorders
- Medications that affect alertness (e.g., barbiturates, benzodiazepines, chloral hydrate, haloperidol, lithium, carbamazepine, phenytoin, etc.)
- History of major head trauma with loss of consciousness
- Ongoing pregnancy
Show all 12Show fewer
- History of metalworking, injury with shrapnel or metal slivers, or major surgery
- History of pacemaker or neurostimulator implantation
- Known taste or smell dysfunction
- A diagnosis of diabetes
- Any known allergy to foods used in the study, or any known life-threatening food allergy
- Tobacco use
Trial locations and contacts
1 site in 1 country.
United States1 site
Modern Diet and Physiology Research Lab
New Haven, Connecticut, 06511
About this study
The primary objective is to test if fat intake moderates the ability of oleoylethanolamide (OEA) to improve weight loss maintenance after the LEARN® weight loss program.
Read the detailed description
The proposed work takes a precision medicine approach to obesity treatment and focuses specifically on weight loss maintenance. We propose to optimize a stratification strategy, using neural, metabolic and behavioral measures to identify individuals who will maintain clinically significant weight loss by daily supplementation with the fatty acid amide, oleoylethanolamide (OEA) following a gold-standard behavioral weight loss program. We will also test a model underlying the efficacy of our intervention to provide insight for the further development of therapeutic avenues. Our first aim is to conduct a randomized double-blind placebo-controlled trial to determine if fat intake moderates the ability of OEA to improve weight loss maintenance after the (LEARN®) weight loss program. We predict fat intake will strongly moderate the ability of OEA to produce clinically significant weight loss and weight loss maintenance 4- and 12-months) after LEARN and that this should not be influenced by sex.
Our second aim is to test if the Dietary Fat and Sugar intake questionnaire (DFS) is associated with measures of saturated fat intake and to optimize a clinically useful stratification strategy. Towards this end we will: (1) perform a neuroimaging study to assess brain response to a high fat milkshake (2) assess blood-based biomarkers of fat intake and synthesis; and (3) collect dietary intake records and food frequency questionnaires (FFQs). We predict that (1) the DFS predicts measures of saturated fat intake (2) that baseline dorsal striatal (DS) response to milkshake predicts weight loss in the OEA but not the placebo group and that connectome based predictive modeling (CPM) reveals a "neural fingerprint" that predicts weight loss on OEA; and (3) LASSO regression will identify baseline measures that best predict outcome to inform selection of a practical clinical stratification recommendation.
Our third aim is to test a model of OEA effectiveness. We predict that weight loss outcome is associated with shifts in fat preference and intake and these effects are mediated by increases in DS response to milkshake in the OEA but not placebo group. We will also test whether high fat diet (HFD) is associated with performance on reinforcement and cognitive measures or changes in energy expenditure or substrate utilization. If so, we will test whether these associations and their reversal by OEA contribute to outcome mediation.
- Conditions
- Overweight and Obesity
- Being tested
- RiduZone (90% OEA), Placebo
- Keywords
- high-fat diet consumers, gut-brain axis
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RiduZone (90% OEA)Dietary supplement
Participants will be randomly assigned to take 2 capsules of RiduZone (each capsule contains 90% OEA ) daily for 16 months
PlaceboDrug
Participants will be randomly assigned to take 2 capsules of placebo daily for 16 months. Placebo capsules will consist of 180mg of hypromellose.
| Study group | Role | What they receive |
|---|---|---|
| RiduZone (90% Oleoylethanolamide (OEA)) | Experimental | Participants will be randomly assigned to take 2 capsules of RiduZone (each capsule contains 90% OEA) daily for 16 months. Receives: Dietary Supplement: RiduZone (90% OEA) |
| Placebo | Placebo comparator | Participants will be randomly assigned to take 2 capsules of placebo daily for 16 months. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent change in body weight
Weight in kg will be used to measure the percent change in body weight.
Measured: Baseline, 4 month, 8 month, and 16 months
Change in absolute body weight
Weight in kg will be used to measure absolute body weight
Measured: Baseline, 4 month, 8 month, and 16 months
Change in waist circumference
Waist circumference to the nearest 0.1 cm
Measured: Baseline, 4 month, 8 month, 16 month
Change in hip circumference
Hip circumference to the nearest 0.1 cm
Measured: Baseline, 4 month, 8 month, and 16 months
Change in thigh circumference
Thigh circumference to the nearest 0.1 cm
Measured: Baseline, 4 month, 8 month, and 16 months
Change in body fat percent
Percentage of body fat measured with bioimpedance analysis
Measured: Baseline, 4 month, 8 month, and 16 months
Change in visceral adipose tissue
Visceral adipose tissue in liters measured with bioimpedance analysis
Measured: Baseline, 4 month, 8 month, 16 month
Change in saturated fat intake as measured by the DFS
Dietary fat intake will be measured monthly by diet fat and sugar intake questionnaire (DFS) and for 16 months starting from baseline. Higher scores indicate a higher frequency of saturated fat intake.
Measured: Baseline, 4 month, 8 month, and 16 months
Change in saturated fat intake as measured by the ASA24
Saturated fat intake will be measured monthly by the automated self-administered 24-Hour recall (ASA24) for 16 months starting from baseline.Saturated fat intake will be reported in grams.
Measured: Baseline, 4 month, 8 month, and 16 months
Change in total saturated fat intake as measured by 3-day food diaries
Saturated fat intake will be measured monthly by 3-day food diaries for 16 months starting from baseline. The 3-day food diaries will be processed with the Nutrition Data System for Research (NDSR). Saturated fat intake will be reported in grams.
Measured: Baseline, 4 month, 8 month, and 16 months
Change in total fat intake as measured by 3-day food diaries
Fat intake will be measured monthly by 3-day food diaries for 16 months starting from baseline. The 3-day food diaries will be processed with the Nutrition Data System for Research (NDSR). Total fat intake will be reported in grams.
Measured: Baseline, 4 month, 8 month, and 16 months
Change in total saturated fat intake as measured by C-reactive protein
Saturated fat intake will be measured by plasma C-reactive protein in mg/L
Measured: Baseline, 8 month
Change in brain response to milkshake
The Blood-oxygen-level-dependent response (BOLD) in the dorsal striatum to the taste of milkshake and tasteless stimuli will be measured using a 3T fMRI scanner at baseline for all participants and at month 8 for participants in the intervention group.
Measured: baseline, 8 month
Change in fat perception with Visual Analogue Scale
Fat perception will be measured with the Visual Analogue Scale. Participants will be asked to sample Jello's and puddings of differing fat concentrations and rate their perceptual attributes at baseline, month 4, month 8, and month 16 The Visual Analogue Scale (VAS) will be used to assess perceptual attributes such as oiliness, fattiness, and creaminess, while accounting for hunger, fullness, thirst, and wanting. The VAS is a horizontal line anchored by 'not at all' at one end and 'extremely' at the other. The scale value of 'not at all' will be 0% and the scale value of 'extremely' will be 100%. Higher values indicate that a subject perceives these attributes as more intense.
Measured: Baseline, 4 month, 8 month, and 16 months
Change in fat perception with General Labeled Magnitude Scale
Fat perception will be measured with the General Labeled Magnitude Scale (GLMS). Participants will be asked to sample Jello's and puddings of differing fat concentrations and rate their perceptual attributes at baseline, month 4, month 8, and month 16 The GLMS will assess intensity perception. The GLMS is a vertical line with quasi-logarithmic spaced labels that start at the bottom 'barely detectable' to 'strongest imaginable' at the top.
Measured: Baseline, 4 month, 8 month, and 16 months
Change in fat preference with Labeled Hedonic Scale
Fat preference will be measured. Participants will be asked to sample Jello's and puddings of differing fat concentrations and rate their hedonic attributes at baseline, month 4, month 8, and month 16 The Labeled Hedonic Scale (LHS) will assess liking. The LHS is a vertical line with quasi-logarithmic spaced labels that start at the bottom with 'most imaginable dislike' and go to 'most imaginable like' at the top, with the label 'neutral' in the middle. The scale value of 'most imaginable dislike' will be -100; the scale value of 'neutral' will be 0; the scale value of 'most imaginable like' will be 100. Higher values indicate greater liking of the sample.
Measured: Baseline, 4 month, 8 month, and 16 months
Change in sensitivity to the long-chain oleic acid C18:1 - measured by a 3-alternative forced choice test
Subjects will be presented with a set of three samples, one test sample with a specific concentration of fat and two control samples. Subjects will be instructed to choose "the odd one out". If the subject chooses incorrectly, the fat concentration of the fatty test sample will be increased in the next set of three samples. If the subject chooses correctly, the next set of three samples will have the fatty test sample would contain the same fat concentration as in the previously correctly identified set with two control samples. This will continue until the subject correctly chooses the fatty test sample three times consecutively.
Measured: Baseline, 4 month, 8 month, 16 month
Change in sugar perception with General Labeled Magnitude Scale
Sugar perception will be measured with the General Labeled Magnitude Scale. Participants will be asked to sample Jello's and puddings of differing sugar concentrations and rate their perceptual and attributes at baseline, month 4, month 8 , and month 16 The GLMS will assess intensity perception. The GLMS is a vertical line with quasi-logarithmic spaced labels that start at the bottom 'barely detectable' to 'strongest imaginable' at the top.
Measured: Baseline, 4 month, 8 month, and 16 months
Change in sugar preference with Labeled Hedonic Scale
Sugar perception will be measured with the Labeled Hedonic Scale. Participants will be asked to sample Jello's and puddings of differing sugar concentrations and rate their hedonic attributes at baseline, month 4, month 8, and month 16 The LHS will assess liking. The LHS is a vertical line with quasi-logarithmic spaced labels that start at the bottom with 'most imaginable dislike' and go to 'most imaginable like' at the top, with the label 'neutral' in the middle.
Measured: Baseline, 4 month, 8 month, and 16 months
Change in fat concentration preference measured by the Monell forced choice test
Fat concentration preference will be measured by the Monell forced-choice test. Participants will be asked to sample Jello's and puddings of differing fat concentrations at baseline, month 4, month 8 , and month 16.
Subjects will be presented with pairs of puddings of varying fat concentrations in a two-series test. Subjects will taste two puddings of different fat concentrations and indicate their preferred pudding. The following pairs of puddings will be presented based on the subject's previous choice. This will continue until selection of the same fat concentration twice relative to both a lower and a higher concentration, or until the lowest or highest concentration is chosen twice consecutively.
Measured: Baseline, 4 month, 8 month, and 16 months
Change in sweet concentration preference measured by the Monell forced choice test
Sweet concentration preference will be measured by the Monell forced-choice test. Participants will be asked to sample Jello's and puddings of differing sugar concentrations at baseline, month 4, month 8 , and month 16.
Subjects will be presented with pairs of puddings/Jello's of varying sugar concentrations in a two-series test. Subjects will taste two puddings/Jello's of different sugar concentrations and indicate their preference. The following pairs of puddings/Jello's will be presented based on the subject's previous choice. This will continue until selection of the same sugar concentration twice relative to both a lower and a higher concentration, or until the lowest or highest concentration is chosen twice consecutively.
Measured: Baseline, 4 month, 8 month, and 16 months
Change in food reinforcement with RED-13
The relative reinforcing value of foods will be measured using the Reward-Related Eating (RED-13) Questionnaire. This questionnaire results in a score from 0 as the lowest measure of reward-based eating drive and 36 as the highest.
Measured: Baseline and 8 month
Change in food reinforcement with Becker DeGroot Markov Auction Task
The relative reinforcing value of foods will be measured using a computerized auction task at baseline and month 8. The relative reinforcing value of foods will be measured with a modified version of the Becker DeGroot Markov Auction task. The outcome measure is willingness to pay, such that higher willingness to pay indicates higher relative reinforcing value of foods.
Measured: Baseline and 8 month
Change in cognition with Kirby Delay Discounting
A neuropsychological test battery will be performed to assess obesity or dopamine-related differences in cognition at baseline, month 4, month 8, and month 16. The neuropsychological test battery will include Kirby Delay Discounting, which measures temporal discounting (tendency for people to prefer small, immediate, monetary rewards over larger, delayed rewards). The steepness of the discounting curve represents the tendency for temporal discounting, such that a more steeply declining curve indicates a tendency to devalue rewards as they become more temporally remote.
Measured: Baseline, 4 month, 8 month, and 16 months
Change in cognition with the Relational Task
A neuropsychological test battery will be performed to assess obesity or dopamine-related differences in cognition at baseline, month 4, month 8, and month 16. The neuropsychological test battery will include the Relational Task which measures visual relational processing. The number of correct responses in the relational condition is the outcome measurement, such that more correct responses indicates higher visual relational processing.
Measured: Baseline, 4 month, 8 month, and 16 months
Change in cognition with Penn Progressive Matrices Test
A neuropsychological test battery will be performed to assess obesity or dopamine-related differences in cognition at baseline, month 4, month 8, and month 16. The neuropsychological test battery will include the Penn Progressive Matrices Test, which measures fluid intelligence. The number of correct responses is the outcome measurement, such that more correct responses indicates higher fluid intelligence.
Measured: Baseline, 4 month, 8 month, and 16 months
Change in cognition with Oral Reading Recognition Test
A neuropsychological test battery will be performed to assess obesity or dopamine-related differences in cognition at baseline, month 4, month 8, and month 16. The neuropsychological test battery will include the Oral Reading Recognition Test, which measures language decoding and reading. The score based on accuracy is the outcome measure, such that a higher score indicates higher language decoding and reading ability.
Measured: Baseline, 4 month, 8 month, and 16 months
Change in cognition with Variable Short Penn Line Orientation Test
A neuropsychological test battery will be performed to assess obesity or dopamine-related differences in cognition at baseline, month 4, month 8, and month 16. The neuropsychological test battery will include the Variable Short Penn Line Orientation Test, which measures visuospatial processing. The number of correct responses is the outcome measure, such that a higher number of correct responses indicates higher visuospatial processing ability.
Measured: Baseline, 4 month, 8 month, and 16 months
Change in cognition with Matrix Reasoning Task (Core NMOB)
A neuropsychological test battery will be performed to assess obesity or dopamine-related differences in cognition at baseline, month 4, month 8, and month 16. The neuropsychological test battery will include the Core Neuropsychological Measures for Obesity and Diabetes (Core NMOB). Core NMOB includes the Matrix Reasoning task, which reflects general cognitive ability or nonverbal reasoning ability. Accuracy across 35 trials is the outcome measure, such that higher accuracy indicates higher general cognitive ability or nonverbal reasoning ability.
Measured: Baseline, 4 month, 8 month, and 16 months
Change in cognition with Digit Symbol Substitution (Core NMOB)
A neuropsychological test battery will be performed to assess obesity or dopamine-related differences in cognition at baseline, month 4, month 8, and month 16. The neuropsychological test battery will include the Core Neuropsychological Measures for Obesity and Diabetes (Core NMOB). Core NMOB includes the Digit Symbol Substitution task, which reflects processing speed. The number of correctly matched symbols, within the administration time (90 seconds) is the outcome measure, such that higher number of correctly matched symbols indicates higher processing speed.
Measured: Baseline, 4 month, 8 month, and 16 months
Change in cognition with Go/No-Go Task (Core NMOB)
A neuropsychological test battery will be performed to assess obesity or dopamine-related differences in cognition at baseline, month 4, month 8, and month 16. The neuropsychological test battery will include the Core Neuropsychological Measures for Obesity and Diabetes (Core NMOB). Core NMOB includes the Go/No-Go task, which reflects response inhibition. The sensitivity index (d') and commission error rate is the outcome measure, such that higher d' and lower commission error rates indicate higher response inhibition.
Measured: Baseline, 4 month, 8 month, and 16 months
Change in cognition with Penn Word Memory Test
A neuropsychological test battery will be performed to assess obesity or dopamine-related differences in cognition at baseline, month 4, month 8, and month 16. The neuropsychological test battery will include the Penn Word Memory Test, which measures verbal episodic memory. The number of correct responses is the outcome measure, such that a higher number of correct responses indicates higher verbal episodic memory.
Measured: Baseline, 4 month, 8 month, and 16 months
Change in cognition with Dimensional Change Card Sorting (Core NMOB)
A neuropsychological test battery will be performed to assess obesity or dopamine-related differences in cognition at baseline, month 4, month 8, and month 16. The neuropsychological test battery will include the Core Neuropsychological Measures for Obesity and Diabetes (Core NMOB). Core NMOB includes the Dimensional Change Card Sorting task, which reflects cognitive flexibility and task-switching ability. The accuracy score is the outcome measure, such that higher accuracy indicates higher cognitive flexibility and task-switching ability.
Measured: Baseline, 4 month, 8 month, and 16 months
Change in cognition with Picture Sequence Memory (Core NMOB)
A neuropsychological test battery will be performed to assess obesity or dopamine-related differences in cognition at baseline, month 4, month 8, and month 16. The neuropsychological test battery will include the Core Neuropsychological Measures for Obesity and Diabetes (Core NMOB). Core NMOB includes the Picture Sequence Memory task, which reflects learning and memory. The accuracy score is the outcome measure, such that higher accuracy indicates higher learning and memory abilities.
Measured: Baseline, 4 month, 8 month, and 16 months
Change in cognition with Stockings of Cambridge (SOC) test (CANTAB)
A neuropsychological test battery will be performed to assess obesity or dopamine-related differences in cognition at baseline, month 4, month 8, and month 16. The neuropsychological test battery will include the Cambridge Neuropsychological Test Automated Battery (CANTAB). The CANTAB includes the Stockings of Cambridge test, which reflects spatial planning. Outcome measures assess the problem difficulty level reached, mean moves used and thinking time are the outcome measures. Scores will be compared to normative data from age and sex-matched peers.
Measured: Baseline, 4 month, 8 month, and 16 months
Change in cognition with Intra-Extra Dimensional Set Shift test (CANTAB)
A neuropsychological test battery will be performed to assess obesity or dopamine-related differences in cognition at baseline, month 4, month 8, and month 16. The neuropsychological test battery will include the Cambridge Neuropsychological Test Automated Battery (CANTAB). The CANTAB includes the Intra-Extra Dimensional Set Shift test, which reflects rule acquisition and reversal. Outcome measures assess the number of errors made, the number of trials completed, the number of stages completed and latency. Scores will be compared to normative data from age and sex-matched peers.
Measured: Baseline, 4 month, 8 month, and 16 months
Change in cognition with delayed non-matching to sample test (CANTAB)
A neuropsychological test battery will be performed to assess obesity or dopamine-related differences in cognition at baseline, month 4, month 8, and month 16. The neuropsychological test battery will include the Cambridge Neuropsychological Test Automated Battery (CANTAB). The CANTAB includes the delayed non-matching to sample test, which reflects visuospatial memory. Outcome measures include latency (the participant's speed of response), the number of correct patterns selected and a statistical measure giving the probability of an error after a correct or incorrect response. Scores will be compared to normative data from age and sex-matched peers.
Measured: Baseline, 4 month, 8 month, and 16 months
Change in cognition with Paired Associates Learning task (CANTAB)
A neuropsychological test battery will be performed to assess obesity or dopamine-related differences in cognition at baseline, month 4, month 8, and month 16. The neuropsychological test battery will include the Cambridge Neuropsychological Test Automated Battery (CANTAB). The CANTAB includes the Paired Associates Learning task, which assesses episodic memory and new learning. Outcome measures include the errors made by the participant, the number of trials required to locate the pattern(s) correctly, memory scores and stages completed. Scores will be compared to normative data from age and sex-matched peers.
Measured: Baseline, 4 month, 8 month, and 16 months
Change in cognition with Probabilistic-Feedback Reward Task
A neuropsychological test battery will be performed to assess obesity or dopamine-related differences in cognition at baseline, month 4, month 8, and month 16. The neuropsychological test battery will include the Probabilistic-Feedback Reward Task, which assesses the ability to learn from positive and negative outcome. Outcome measures include the number of times a symbol associated with positive feedback is chosen and the number of times a symbol associated with negative feedback is avoided. Scores will be compared to normative data from age and sex-matched peers.
Measured: Baseline, 4 month, 8 month, and 16 months
Change in resting energy expenditure
Indirect Calorimetry (IC) will be performed to measure fasting resting energy expenditure at baseline and month 8.
Measured: Baseline and 8 month
Change in respiratory exchange ratio
Indirect Calorimetry (IC) will be performed to measure fasting respiratory exchange ratio at baseline and month 8
Measured: Baseline and 8 month
Secondary outcomes (4)
Change in Healthy Eating Index (HEI)
The overall Healthy Eating Index 2015 (HEI-2015) score will be calculated for each participant from 3-day food diaries processed through NDSR. This score is made up of 13 components that reflect recommendations in the 2015-2020 Dietary Guidelines for Americans. The maximum score for the HEI is 100, where points are awarded based on adequate intakes of total fruit, whole fruits, total vegetables, greens and beans, whole grains, dairy, protein foods, seafood and plant proteins, and unsaturated fatty acids. Points are also awarded for moderate intakes of refined grains, sodium, added sugars and saturated fats.
Measured: Baseline, 4 month, 8 month, 16 month
Change in 3-day food diary total solid fat intake
Solid fat intake will be measured monthly by 3-day food diaries for 16 months starting from baseline. The 3-day food diaries will be processed with the Nutrition Data System for Research (NDSR) and solid fat intake will be reported in grams.
Measured: Baseline, 4 month, 8 month, 16 month
Change in saturated fat intake measured by plasma cholesterol
Plasma cholesterol LDL/HDL will be measured at baseline and month 8
Measured: Baseline, 8 month
Change in saturated fat intake measured by plasma triglycerides
Plasma triglycerides will be measured at baseline and month 8
Measured: Baseline, 8 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2020
- Study start6 Apr 2021
- Primary completion4 Oct 2024
- Study completion4 Oct 2024
Why it stopped: PI changed institutions
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Overweight and ObesityStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Investigators are testing the hypotheses that high fat diet consumers will show the greatest benefit from supplementation with oleoylethanolamide (OEA) in terms of weight loss maintenance, because OEA targets brain adaptations that are related to high fat diet.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04614233
- Sponsor's protocol ID
- 2000028769
- Other IDs
- 1R01DK126295-01A1
- Status last verified
- Jan 2025
- First submitted
- 14 Oct 2020
- Last updated
- 10 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Arjmand G, Morys FM, Sung JJ, Duncan CC, Davis XS, Heshmati S, Fang X, White MA, Grilo CM, Small DM. Identification of cognitive factors that predict behavioural weight-loss intervention outcomes. Int J Obes (Lond). 2026 Aug 29. doi: 10.1038/s41366-026-02191-3. Online ahead of print.
PubMed 42668311Fang X, Davis X, Flack KD, Duncan C, Li F, White M, Grilo C, Small DM. Dietary adaptation for weight loss maintenance at Yale (DAWLY): Protocol and predictions for a randomized controlled trial. Front Nutr. 2022 Jul 28;9:940064. doi: 10.3389/fnut.2022.940064. eCollection 2022.
PubMed 35967820
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Targeting the Gut-brain Axis to Facilitate Weight Loss in High Fat Diet Consumers
- ClinicalTrials.gov ID
- NCT04614233
- Acronym / sponsor ID
- 2000028769
- Conditions
- Overweight and Obesity
- Keywords
- high-fat diet consumers, gut-brain axis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: PI changed institutions
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 6 Apr 2021 (actual)
- Primary completion
- 4 Oct 2024 (actual)
- Study completion
- 4 Oct 2024 (actual)
- First posted
- 3 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective is to test if fat intake moderates the ability of oleoylethanolamide (OEA) to improve weight loss maintenance after the LEARN® weight loss program.
Detailed description
The proposed work takes a precision medicine approach to obesity treatment and focuses specifically on weight loss maintenance. We propose to optimize a stratification strategy, using neural, metabolic and behavioral measures to identify individuals who will maintain clinically significant weight loss by daily supplementation with the fatty acid amide, oleoylethanolamide (OEA) following a gold-standard behavioral weight loss program. We will also test a model underlying the efficacy of our intervention to provide insight for the further development of therapeutic avenues. Our first aim is to conduct a randomized double-blind placebo-controlled trial to determine if fat intake moderates the ability of OEA to improve weight loss maintenance after the (LEARN®) weight loss program. We predict fat intake will strongly moderate the ability of OEA to produce clinically significant weight loss and weight loss maintenance 4- and 12-months) after LEARN and that this should not be influenced by sex.
Our second aim is to test if the Dietary Fat and Sugar intake questionnaire (DFS) is associated with measures of saturated fat intake and to optimize a clinically useful stratification strategy. Towards this end we will: (1) perform a neuroimaging study to assess brain response to a high fat milkshake (2) assess blood-based biomarkers of fat intake and synthesis; and (3) collect dietary intake records and food frequency questionnaires (FFQs). We predict that (1) the DFS predicts measures of saturated fat intake (2) that baseline dorsal striatal (DS) response to milkshake predicts weight loss in the OEA but not the placebo group and that connectome based predictive modeling (CPM) reveals a "neural fingerprint" that predicts weight loss on OEA; and (3) LASSO regression will identify baseline measures that best predict outcome to inform selection of a practical clinical stratification recommendation.
Our third aim is to test a model of OEA effectiveness. We predict that weight loss outcome is associated with shifts in fat preference and intake and these effects are mediated by increases in DS response to milkshake in the OEA but not placebo group. We will also test whether high fat diet (HFD) is associated with performance on reinforcement and cognitive measures or changes in energy expenditure or substrate utilization. If so, we will test whether these associations and their reversal by OEA contribute to outcome mediation.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Investigators are testing the hypotheses that high fat diet consumers will show the greatest benefit from supplementation with oleoylethanolamide (OEA) in terms of weight loss maintenance, because OEA targets brain adaptations that are related to high fat diet.
| Arm | Type | Receives |
|---|---|---|
| RiduZone (90% Oleoylethanolamide (OEA)) | Experimental | Dietary Supplement: RiduZone (90% OEA)Participants will be randomly assigned to take 2 capsules of RiduZone (each capsule contains 90% OEA) daily for 16 months. |
| Placebo | Placebo comparator | Drug: PlaceboParticipants will be randomly assigned to take 2 capsules of placebo daily for 16 months. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Ages 18-55
- Right-handed with a score of ≥ +50 on the modified Edinburgh handedness scale
- English-speaking
- BMI > 25.0
- Comfortable with the fMRI procedures during the mock scanning session and rate milkshake as at least mildly liked
Key exclusion criteria (12 listed)
- Serious or unstable medical illness (e.g., cancer)
- Past or current history of alcoholism or consistent drug use
- Current major psychiatric illness as defined by DSM-IV criteria including eating disorders
- Medications that affect alertness (e.g., barbiturates, benzodiazepines, chloral hydrate, haloperidol, lithium, carbamazepine, phenytoin, etc.)
- History of major head trauma with loss of consciousness
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RiduZone (90% OEA)Participants will be randomly assigned to take 2 capsules of RiduZone (each capsule contains 90% OEA ) daily for 16 months | Dietary supplement | RiduZone (90% Oleoylethanolamide (OEA)) |
| PlaceboParticipants will be randomly assigned to take 2 capsules of placebo daily for 16 months. Placebo capsules will consist of 180mg of hypromellose. | Drug | Placebo |
Primary outcome
Percent change in body weight
Time frame: Baseline, 4 month, 8 month, and 16 months
Weight in kg will be used to measure the percent change in body weight.
Change in absolute body weight
Time frame: Baseline, 4 month, 8 month, and 16 months
Weight in kg will be used to measure absolute body weight
Change in waist circumference
Time frame: Baseline, 4 month, 8 month, 16 month
Waist circumference to the nearest 0.1 cm
Change in hip circumference
Time frame: Baseline, 4 month, 8 month, and 16 months
Hip circumference to the nearest 0.1 cm
Change in thigh circumference
Time frame: Baseline, 4 month, 8 month, and 16 months
Thigh circumference to the nearest 0.1 cm
Change in body fat percent
Time frame: Baseline, 4 month, 8 month, and 16 months
Percentage of body fat measured with bioimpedance analysis
Change in visceral adipose tissue
Time frame: Baseline, 4 month, 8 month, 16 month
Visceral adipose tissue in liters measured with bioimpedance analysis
Change in saturated fat intake as measured by the DFS
Time frame: Baseline, 4 month, 8 month, and 16 months
Dietary fat intake will be measured monthly by diet fat and sugar intake questionnaire (DFS) and for 16 months starting from baseline. Higher scores indicate a higher frequency of saturated fat intake.
Change in saturated fat intake as measured by the ASA24
Time frame: Baseline, 4 month, 8 month, and 16 months
Saturated fat intake will be measured monthly by the automated self-administered 24-Hour recall (ASA24) for 16 months starting from baseline.Saturated fat intake will be reported in grams.
Change in total saturated fat intake as measured by 3-day food diaries
Time frame: Baseline, 4 month, 8 month, and 16 months
Saturated fat intake will be measured monthly by 3-day food diaries for 16 months starting from baseline. The 3-day food diaries will be processed with the Nutrition Data System for Research (NDSR). Saturated fat intake will be reported in grams.
Change in total fat intake as measured by 3-day food diaries
Time frame: Baseline, 4 month, 8 month, and 16 months
Fat intake will be measured monthly by 3-day food diaries for 16 months starting from baseline. The 3-day food diaries will be processed with the Nutrition Data System for Research (NDSR). Total fat intake will be reported in grams.
Change in total saturated fat intake as measured by C-reactive protein
Time frame: Baseline, 8 month
Saturated fat intake will be measured by plasma C-reactive protein in mg/L
Change in brain response to milkshake
Time frame: baseline, 8 month
The Blood-oxygen-level-dependent response (BOLD) in the dorsal striatum to the taste of milkshake and tasteless stimuli will be measured using a 3T fMRI scanner at baseline for all participants and at month 8 for participants in the intervention group.
Change in fat perception with Visual Analogue Scale
Time frame: Baseline, 4 month, 8 month, and 16 months
Fat perception will be measured with the Visual Analogue Scale. Participants will be asked to sample Jello's and puddings of differing fat concentrations and rate their perceptual attributes at baseline, month 4, month 8, and month 16 The Visual Analogue Scale (VAS) will be used to assess perceptual attributes such as oiliness, fattiness, and creaminess, while accounting for hunger, fullness, thirst, and wanting. The VAS is a horizontal line anchored by 'not at all' at one end and 'extremely' at the other. The scale value of 'not at all' will be 0% and the scale value of 'extremely' will be 100%. Higher values indicate that a subject perceives these attributes as more intense.
Change in fat perception with General Labeled Magnitude Scale
Time frame: Baseline, 4 month, 8 month, and 16 months
Fat perception will be measured with the General Labeled Magnitude Scale (GLMS). Participants will be asked to sample Jello's and puddings of differing fat concentrations and rate their perceptual attributes at baseline, month 4, month 8, and month 16 The GLMS will assess intensity perception. The GLMS is a vertical line with quasi-logarithmic spaced labels that start at the bottom 'barely detectable' to 'strongest imaginable' at the top.
Change in fat preference with Labeled Hedonic Scale
Time frame: Baseline, 4 month, 8 month, and 16 months
Fat preference will be measured. Participants will be asked to sample Jello's and puddings of differing fat concentrations and rate their hedonic attributes at baseline, month 4, month 8, and month 16 The Labeled Hedonic Scale (LHS) will assess liking. The LHS is a vertical line with quasi-logarithmic spaced labels that start at the bottom with 'most imaginable dislike' and go to 'most imaginable like' at the top, with the label 'neutral' in the middle. The scale value of 'most imaginable dislike' will be -100; the scale value of 'neutral' will be 0; the scale value of 'most imaginable like' will be 100. Higher values indicate greater liking of the sample.
Change in sensitivity to the long-chain oleic acid C18:1 - measured by a 3-alternative forced choice test
Time frame: Baseline, 4 month, 8 month, 16 month
Subjects will be presented with a set of three samples, one test sample with a specific concentration of fat and two control samples. Subjects will be instructed to choose "the odd one out". If the subject chooses incorrectly, the fat concentration of the fatty test sample will be increased in the next set of three samples. If the subject chooses correctly, the next set of three samples will have the fatty test sample would contain the same fat concentration as in the previously correctly identified set with two control samples. This will continue until the subject correctly chooses the fatty test sample three times consecutively.
Change in sugar perception with General Labeled Magnitude Scale
Time frame: Baseline, 4 month, 8 month, and 16 months
Sugar perception will be measured with the General Labeled Magnitude Scale. Participants will be asked to sample Jello's and puddings of differing sugar concentrations and rate their perceptual and attributes at baseline, month 4, month 8 , and month 16 The GLMS will assess intensity perception. The GLMS is a vertical line with quasi-logarithmic spaced labels that start at the bottom 'barely detectable' to 'strongest imaginable' at the top.
Change in sugar preference with Labeled Hedonic Scale
Time frame: Baseline, 4 month, 8 month, and 16 months
Sugar perception will be measured with the Labeled Hedonic Scale. Participants will be asked to sample Jello's and puddings of differing sugar concentrations and rate their hedonic attributes at baseline, month 4, month 8, and month 16 The LHS will assess liking. The LHS is a vertical line with quasi-logarithmic spaced labels that start at the bottom with 'most imaginable dislike' and go to 'most imaginable like' at the top, with the label 'neutral' in the middle.
Change in fat concentration preference measured by the Monell forced choice test
Time frame: Baseline, 4 month, 8 month, and 16 months
Fat concentration preference will be measured by the Monell forced-choice test. Participants will be asked to sample Jello's and puddings of differing fat concentrations at baseline, month 4, month 8 , and month 16. Subjects will be presented with pairs of puddings of varying fat concentrations in a two-series test. Subjects will taste two puddings of different fat concentrations and indicate their preferred pudding. The following pairs of puddings will be presented based on the subject's previous choice. This will continue until selection of the same fat concentration twice relative to both a lower and a higher concentration, or until the lowest or highest concentration is chosen twice consecutively.
Change in sweet concentration preference measured by the Monell forced choice test
Time frame: Baseline, 4 month, 8 month, and 16 months
Sweet concentration preference will be measured by the Monell forced-choice test. Participants will be asked to sample Jello's and puddings of differing sugar concentrations at baseline, month 4, month 8 , and month 16. Subjects will be presented with pairs of puddings/Jello's of varying sugar concentrations in a two-series test. Subjects will taste two puddings/Jello's of different sugar concentrations and indicate their preference. The following pairs of puddings/Jello's will be presented based on the subject's previous choice. This will continue until selection of the same sugar concentration twice relative to both a lower and a higher concentration, or until the lowest or highest concentration is chosen twice consecutively.
Change in food reinforcement with RED-13
Time frame: Baseline and 8 month
The relative reinforcing value of foods will be measured using the Reward-Related Eating (RED-13) Questionnaire. This questionnaire results in a score from 0 as the lowest measure of reward-based eating drive and 36 as the highest.
Change in food reinforcement with Becker DeGroot Markov Auction Task
Time frame: Baseline and 8 month
The relative reinforcing value of foods will be measured using a computerized auction task at baseline and month 8. The relative reinforcing value of foods will be measured with a modified version of the Becker DeGroot Markov Auction task. The outcome measure is willingness to pay, such that higher willingness to pay indicates higher relative reinforcing value of foods.
Change in cognition with Kirby Delay Discounting
Time frame: Baseline, 4 month, 8 month, and 16 months
A neuropsychological test battery will be performed to assess obesity or dopamine-related differences in cognition at baseline, month 4, month 8, and month 16. The neuropsychological test battery will include Kirby Delay Discounting, which measures temporal discounting (tendency for people to prefer small, immediate, monetary rewards over larger, delayed rewards). The steepness of the discounting curve represents the tendency for temporal discounting, such that a more steeply declining curve indicates a tendency to devalue rewards as they become more temporally remote.
Change in cognition with the Relational Task
Time frame: Baseline, 4 month, 8 month, and 16 months
A neuropsychological test battery will be performed to assess obesity or dopamine-related differences in cognition at baseline, month 4, month 8, and month 16. The neuropsychological test battery will include the Relational Task which measures visual relational processing. The number of correct responses in the relational condition is the outcome measurement, such that more correct responses indicates higher visual relational processing.
Change in cognition with Penn Progressive Matrices Test
Time frame: Baseline, 4 month, 8 month, and 16 months
A neuropsychological test battery will be performed to assess obesity or dopamine-related differences in cognition at baseline, month 4, month 8, and month 16. The neuropsychological test battery will include the Penn Progressive Matrices Test, which measures fluid intelligence. The number of correct responses is the outcome measurement, such that more correct responses indicates higher fluid intelligence.
Change in cognition with Oral Reading Recognition Test
Time frame: Baseline, 4 month, 8 month, and 16 months
A neuropsychological test battery will be performed to assess obesity or dopamine-related differences in cognition at baseline, month 4, month 8, and month 16. The neuropsychological test battery will include the Oral Reading Recognition Test, which measures language decoding and reading. The score based on accuracy is the outcome measure, such that a higher score indicates higher language decoding and reading ability.
Change in cognition with Variable Short Penn Line Orientation Test
Time frame: Baseline, 4 month, 8 month, and 16 months
A neuropsychological test battery will be performed to assess obesity or dopamine-related differences in cognition at baseline, month 4, month 8, and month 16. The neuropsychological test battery will include the Variable Short Penn Line Orientation Test, which measures visuospatial processing. The number of correct responses is the outcome measure, such that a higher number of correct responses indicates higher visuospatial processing ability.
Change in cognition with Matrix Reasoning Task (Core NMOB)
Time frame: Baseline, 4 month, 8 month, and 16 months
A neuropsychological test battery will be performed to assess obesity or dopamine-related differences in cognition at baseline, month 4, month 8, and month 16. The neuropsychological test battery will include the Core Neuropsychological Measures for Obesity and Diabetes (Core NMOB). Core NMOB includes the Matrix Reasoning task, which reflects general cognitive ability or nonverbal reasoning ability. Accuracy across 35 trials is the outcome measure, such that higher accuracy indicates higher general cognitive ability or nonverbal reasoning ability.
Change in cognition with Digit Symbol Substitution (Core NMOB)
Time frame: Baseline, 4 month, 8 month, and 16 months
A neuropsychological test battery will be performed to assess obesity or dopamine-related differences in cognition at baseline, month 4, month 8, and month 16. The neuropsychological test battery will include the Core Neuropsychological Measures for Obesity and Diabetes (Core NMOB). Core NMOB includes the Digit Symbol Substitution task, which reflects processing speed. The number of correctly matched symbols, within the administration time (90 seconds) is the outcome measure, such that higher number of correctly matched symbols indicates higher processing speed.
Change in cognition with Go/No-Go Task (Core NMOB)
Time frame: Baseline, 4 month, 8 month, and 16 months
A neuropsychological test battery will be performed to assess obesity or dopamine-related differences in cognition at baseline, month 4, month 8, and month 16. The neuropsychological test battery will include the Core Neuropsychological Measures for Obesity and Diabetes (Core NMOB). Core NMOB includes the Go/No-Go task, which reflects response inhibition. The sensitivity index (d') and commission error rate is the outcome measure, such that higher d' and lower commission error rates indicate higher response inhibition.
Change in cognition with Penn Word Memory Test
Time frame: Baseline, 4 month, 8 month, and 16 months
A neuropsychological test battery will be performed to assess obesity or dopamine-related differences in cognition at baseline, month 4, month 8, and month 16. The neuropsychological test battery will include the Penn Word Memory Test, which measures verbal episodic memory. The number of correct responses is the outcome measure, such that a higher number of correct responses indicates higher verbal episodic memory.
Change in cognition with Dimensional Change Card Sorting (Core NMOB)
Time frame: Baseline, 4 month, 8 month, and 16 months
A neuropsychological test battery will be performed to assess obesity or dopamine-related differences in cognition at baseline, month 4, month 8, and month 16. The neuropsychological test battery will include the Core Neuropsychological Measures for Obesity and Diabetes (Core NMOB). Core NMOB includes the Dimensional Change Card Sorting task, which reflects cognitive flexibility and task-switching ability. The accuracy score is the outcome measure, such that higher accuracy indicates higher cognitive flexibility and task-switching ability.
Change in cognition with Picture Sequence Memory (Core NMOB)
Time frame: Baseline, 4 month, 8 month, and 16 months
A neuropsychological test battery will be performed to assess obesity or dopamine-related differences in cognition at baseline, month 4, month 8, and month 16. The neuropsychological test battery will include the Core Neuropsychological Measures for Obesity and Diabetes (Core NMOB). Core NMOB includes the Picture Sequence Memory task, which reflects learning and memory. The accuracy score is the outcome measure, such that higher accuracy indicates higher learning and memory abilities.
Change in cognition with Stockings of Cambridge (SOC) test (CANTAB)
Time frame: Baseline, 4 month, 8 month, and 16 months
A neuropsychological test battery will be performed to assess obesity or dopamine-related differences in cognition at baseline, month 4, month 8, and month 16. The neuropsychological test battery will include the Cambridge Neuropsychological Test Automated Battery (CANTAB). The CANTAB includes the Stockings of Cambridge test, which reflects spatial planning. Outcome measures assess the problem difficulty level reached, mean moves used and thinking time are the outcome measures. Scores will be compared to normative data from age and sex-matched peers.
Change in cognition with Intra-Extra Dimensional Set Shift test (CANTAB)
Time frame: Baseline, 4 month, 8 month, and 16 months
A neuropsychological test battery will be performed to assess obesity or dopamine-related differences in cognition at baseline, month 4, month 8, and month 16. The neuropsychological test battery will include the Cambridge Neuropsychological Test Automated Battery (CANTAB). The CANTAB includes the Intra-Extra Dimensional Set Shift test, which reflects rule acquisition and reversal. Outcome measures assess the number of errors made, the number of trials completed, the number of stages completed and latency. Scores will be compared to normative data from age and sex-matched peers.
Change in cognition with delayed non-matching to sample test (CANTAB)
Time frame: Baseline, 4 month, 8 month, and 16 months
A neuropsychological test battery will be performed to assess obesity or dopamine-related differences in cognition at baseline, month 4, month 8, and month 16. The neuropsychological test battery will include the Cambridge Neuropsychological Test Automated Battery (CANTAB). The CANTAB includes the delayed non-matching to sample test, which reflects visuospatial memory. Outcome measures include latency (the participant's speed of response), the number of correct patterns selected and a statistical measure giving the probability of an error after a correct or incorrect response. Scores will be compared to normative data from age and sex-matched peers.
Change in cognition with Paired Associates Learning task (CANTAB)
Time frame: Baseline, 4 month, 8 month, and 16 months
A neuropsychological test battery will be performed to assess obesity or dopamine-related differences in cognition at baseline, month 4, month 8, and month 16. The neuropsychological test battery will include the Cambridge Neuropsychological Test Automated Battery (CANTAB). The CANTAB includes the Paired Associates Learning task, which assesses episodic memory and new learning. Outcome measures include the errors made by the participant, the number of trials required to locate the pattern(s) correctly, memory scores and stages completed. Scores will be compared to normative data from age and sex-matched peers.
Change in cognition with Probabilistic-Feedback Reward Task
Time frame: Baseline, 4 month, 8 month, and 16 months
A neuropsychological test battery will be performed to assess obesity or dopamine-related differences in cognition at baseline, month 4, month 8, and month 16. The neuropsychological test battery will include the Probabilistic-Feedback Reward Task, which assesses the ability to learn from positive and negative outcome. Outcome measures include the number of times a symbol associated with positive feedback is chosen and the number of times a symbol associated with negative feedback is avoided. Scores will be compared to normative data from age and sex-matched peers.
Change in resting energy expenditure
Time frame: Baseline and 8 month
Indirect Calorimetry (IC) will be performed to measure fasting resting energy expenditure at baseline and month 8.
Change in respiratory exchange ratio
Time frame: Baseline and 8 month
Indirect Calorimetry (IC) will be performed to measure fasting respiratory exchange ratio at baseline and month 8
4 secondary outcomes
Change in Healthy Eating Index (HEI)
Time frame: Baseline, 4 month, 8 month, 16 month
Change in 3-day food diary total solid fat intake
Time frame: Baseline, 4 month, 8 month, 16 month
Change in saturated fat intake measured by plasma cholesterol
Time frame: Baseline, 8 month
Change in saturated fat intake measured by plasma triglycerides
Time frame: Baseline, 8 month
Results and safety
The study was stopped early (reason given: PI changed institutions). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2025.
- Derived from this study: PubMed 42668311Arjmand G, Morys FM, Sung JJ, Duncan CC, Davis XS, Heshmati S, Fang X, White MA, Grilo CM, Small DM. Identification of cognitive factors that predict behavioural weight-loss intervention outcomes. Int J Obes (Lond). 2026 Aug 29. doi: 10.1038/s41366-026-02191-3. Online ahead of print.
- Derived from this study: PubMed 35967820Fang X, Davis X, Flack KD, Duncan C, Li F, White M, Grilo C, Small DM. Dietary adaptation for weight loss maintenance at Yale (DAWLY): Protocol and predictions for a randomized controlled trial. Front Nutr. 2022 Jul 28;9:940064. doi: 10.3389/fnut.2022.940064. eCollection 2022.
- Individual participant dataSharing planned: Yes
Related trials for Overweight and Obesity
RecruitingObservational study
Endoscopic Sleeve Gastroplasty (ESG) Prospective Trial for Obesity (EGO-Trial)
Obesity
Active, not recruitingPhase 4
Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
Recruiting
Exercise Training and Vitamin D Metabolism
Obesity & Overweight, Vitamin D
Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing RiduZone (90% OEA) in people with Overweight and Obesity, run by Yale University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 10 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: PI changed institutions). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent change in body weight (time frame: Baseline, 4 month, 8 month, and 16 months). The study lists 41 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04614233, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2025.