Healthy DietNCT03407053
Effect of Ultra Processed Versus Unprocessed Diets on Energy Intake
A study testing Ultra-processed diet and Unprocessed diet in people with Healthy Diet, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 1 site in United States.
Trial summary
Background: Eating too much processed food is believed to lead to obesity. But the effect of processed food on energy intake has not been carefully studied. Researchers want to study people s diets for 4 weeks and do specialized tests of the effects. Participants will get two diets. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Diet
- What is being tested?
- Ultra-processed diet and Unprocessed diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2018to 26 Feb 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Adults age 18-50 years, male and female
- Weight stable (< +/- 5 % over past 6 months)
- 4. Body mass index (BMI) greater than or equal to 18 kg/m^2
- 5. Willing to cease their habitual caffeine intake during the study, beginning one week prior to inpatient admission
- 6. Written informed consent
- 7. Willing to eat the food provided in the study
- 8. Able to complete daily bouts of stationary cycling at a moderate rate and intensity with a heart rate (HR) equal to or greater than 0.3x(220-age-HR(rest))+HR(rest) but not exceeding 0.4x(220-age-HR(rest))+HR(rest) and no signs of arrhythmia
Who cannot join
- Evidence of metabolic or cardiovascular disease, or disease that may influence metabolism (e.g. cancer, diabetes, thyroid disease)
- Taking any prescription medication or other drug that may influence metabolism (e.g. diet/weight-loss medication, asthma medication, blood pressure medication, psychiatric medications, corticosteroids, or other medications at the discretion of the PI and/or study team)
- Hematocrit < 34% (women only)
- Hematocrit < 40% (men only)
- Pregnancy, lactation (women only)
- Participating in a regular exercise program (> 2h/week of vigorous activity)
Show all 14Show fewer
- Caffeine consumption > 300 mg/day
- Regular use of alcohol (> 2 drinks per day), tobacco (smoking or chewing) amphetamines, cocaine, heroin, or marijuana over past 6 months
- Eating disorders or psychological conditions, such as (but not limited to) claustrophobia, clinical depression, bi-polar disorders, that would be incompatible with safe and successful participation in this study, as determined by investigators.
- --Past or present history of claustrophobia since part of the protocol will involve being confined to a small room for whole-body indirect calorimetry and being in an MRI scanner for liver fat measures
- Implants, devices, or foreign objects implanted in the body that interfere with the Magnetic Resonance procedures
- Volunteers with strict dietary concerns (e.g. vegetarian or kosher diet, food allergies)
- Volunteers unwilling or unable to give informed consent
- Non-English speakers due to unavailability of required questionnaires in other languages.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
About this study
Background:
Eating too much processed food is believed to lead to obesity. But the effect of processed food on energy intake has not been carefully studied. Researchers want to study people s diets for 4 weeks and do specialized tests of the effects. Participants will get two diets. They will have the same calories and nutrients, but one diet will be unprocessed food and the other will be ultra-processed.
Read more
Objective:
To better understand how processed and unprocessed foods affect daily food consumption and how the body handles blood sugar.
Eligibility:
Healthy adults ages 18-50 who have stable weight and can exercise
Design:
Participants will not eat for 12 hours. Then they will be screened with:
- Medical history
- Physical exam
- Heart and blood tests
- Resting energy expenditure test (REE). A hood will collect air exhaled while lying down for 30-40 minutes.
- Psychiatric questions
- Questions about mood, eating, sleep, and socioeconomic status
- 20-minute stationary biking
Female participants will have a urine pregnancy test.
Participants will stay in the clinic for 4 weeks. For 2 weeks they will get a processed diet. For the other 2 weeks they will get an unprocessed diet. Participants cannot use the study period to gain or lose weight.
Participants will have:
- Meals and snacks provided
- Daily exercise
- Blood, urine, and saliva tests
- To drink a special water and a very sweet liquid
- REE
- Scans and X-rays
- To wear activity monitors and a device to measure blood sugar
- Several 24-hour periods in a room that measures oxygen and carbon dioxide
- Repeats of screening questions
- Questions about hunger and meals
- Sleep monitoring
- Taste tests
Read the detailed description
Overconsumption of foods that result from extensive industrial processing is believed to contribute to the development of obesity. Ultra-processed foods now represent most of the calories consumed in America and their contribution to overall diet has increased in parallel with the rise in the prevalence of obesity over the past several decades. While such correlations are suggestive, the effect of industrial processing per se, independent of dietary macronutrient composition, on ad libitum energy intake has not been carefully investigated. Therefore, we will conduct feeding studies in adult men and women to investigate the differences in ad libitum energy intake resulting from consuming test diets for a pair of 2-week periods in a randomized, crossover design during a single 4-week period. The test diets presented to participants will be matched for calories, macronutrient composition, sugar, fiber, and sodium, but one diet will be composed of ultra-processed foods whereas the other diet will be unprocessed foods.
- Conditions
- Healthy Diet
- Being tested
- Ultra-processed diet, Unprocessed diet
- Keywords
- Calories, Food Intake, Glucose, Body Composition, Body Weight Regulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultra-processed dietDietary supplement
Consuming ultra-processed diet over a 2-week period
Unprocessed dietDietary supplement
Consuming unprocessed diet over a 2-week period
| Study group | Role | What they receive |
|---|---|---|
| Ultra-processed diet then unprocessed diet | Active comparator | Participants assigned to this arm will consume ultra-processed diet for two weeks followed by unprocessed diet for two weeks Receives: Dietary Supplement: Ultra-processed diet; Dietary Supplement: Unprocessed diet |
| Unprocessed diet then ultra-processed diet | Active comparator | Participants assigned to this arm will consume unprocessed diet for two weeks followed by ultra-processed diet for two weeks Receives: Dietary Supplement: Ultra-processed diet; Dietary Supplement: Unprocessed diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ad Libitum Energy Intake
Ad libitum energy intake averaged over 14 days for each diet, measured in kilocalories (kcal) per day.
Measured: 14 days
Secondary outcomes (2)
Change in Body Weight
Change in body weight from baseline to day 14 for each diet, measured in kilograms (kg)
Measured: Baseline and day 14
Change in Fat Mass
Change in body fat mass from baseline to day 14 for each diet, measured in kilograms (kg). Body fat mass was measured using Dual-energy X-ray absorptiometry (DXA) measurements.
Measured: Baseline and day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2018
- Study start1 Mar 2018
- Primary completion26 Feb 2020
- Study completion26 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Healthy DietStudies of the same condition, open and under way.
- More trials run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)The 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 N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Kevin Hall, Ph.D., Principal investigator, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03407053
- Sponsor's protocol ID
- 180044
- Other IDs
- 18-DK-0044
- Status last verified
- 28 Jan 2021
- First submitted
- 20 Jan 2018
- Last updated
- 29 Jun 2021
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Hall KD, Ayuketah A, Brychta R, Cai H, Cassimatis T, Chen KY, Chung ST, Costa E, Courville A, Darcey V, Fletcher LA, Forde CG, Gharib AM, Guo J, Howard R, Joseph PV, McGehee S, Ouwerkerk R, Raisinger K, Rozga I, Stagliano M, Walter M, Walter PJ, Yang S, Zhou M. Ultra-Processed Diets Cause Excess Calorie Intake and Weight Gain: An Inpatient Randomized Controlled Trial of Ad Libitum Food Intake. Cell Metab. 2019 Jul 2;30(1):67-77.e3. doi: 10.1016/j.cmet.2019.05.008. Epub 2019 May 16.
PubMed 31105044Brunstrom JM, Schatzker M, Rogers PJ, Courville AB, Hall KD, Flynn AN. Consuming an unprocessed diet reduces energy intake: a post-hoc analysis of a randomized controlled trial reveals a role for human nutritional intelligence. Am J Clin Nutr. 2026 Mar;123(3):101183. doi: 10.1016/j.ajcnut.2025.101183. Epub 2025 Dec 29.
PubMed 41475551Abar L, Steele EM, Lee SK, Kahle L, Moore SC, Watts E, O'Connell CP, Matthews CE, Herrick KA, Hall KD, O'Connor LE, Freedman ND, Sinha R, Hong HG, Loftfield E. Identification and validation of poly-metabolite scores for diets high in ultra-processed food: An observational study and post-hoc randomized controlled crossover-feeding trial. PLoS Med. 2025 May 20;22(5):e1004560. doi: 10.1371/journal.pmed.1004560. eCollection 2025 May.
PubMed 40392756Hengist A, Ong JA, McNeel K, Guo J, Hall KD. Imprecision nutrition? Intraindividual variability of glucose responses to duplicate presented meals in adults without diabetes. Am J Clin Nutr. 2025 Jan;121(1):74-82. doi: 10.1016/j.ajcnut.2024.10.007. Epub 2024 Dec 2.
PubMed 39755436Sciarrillo CM, Guo J, Hengist A, Darcey VL, Hall KD. Diet order significantly affects energy balance for diets varying in macronutrients but not ultraprocessing in crossover studies without a washout period. Am J Clin Nutr. 2024 Oct;120(4):953-963. doi: 10.1016/j.ajcnut.2024.08.013. Epub 2024 Aug 18.
PubMed 39163976Sciarrillo CM, Guo J, Hengist A, Darcey VL, Hall KD. Diet order affects energy balance in randomized crossover feeding studies that vary in macronutrients but not ultra-processing. medRxiv [Preprint]. 2023 Oct 4:2023.10.03.23296501. doi: 10.1101/2023.10.03.23296501.
PubMed 37986904O'Connor LE, Hall KD, Herrick KA, Reedy J, Chung ST, Stagliano M, Courville AB, Sinha R, Freedman ND, Hong HG, Albert PS, Loftfield E. Metabolomic Profiling of an Ultraprocessed Dietary Pattern in a Domiciled Randomized Controlled Crossover Feeding Trial. J Nutr. 2023 Aug;153(8):2181-2192. doi: 10.1016/j.tjnut.2023.06.003. Epub 2023 Jun 3.
PubMed 37276937Jaime-Lara RB, Franks AT, Agarwal K, Nawal N, Courville AB, Guo J, Yang S, Brooks BE, Roy A, Taylor K, Darcey VL, LeCheminant JD, Chung S, Forde CG, Hall KD, Joseph PV. No significant salt or sweet taste preference or sensitivity differences following ad libitum consumption of ultra-processed and unprocessed diets: a randomized controlled pilot study. Chem Senses. 2023 Jan 1;48:bjad007. doi: 10.1093/chemse/bjad007.
PubMed 36897799Howard R, Guo J, Hall KD. Imprecision nutrition? Different simultaneous continuous glucose monitors provide discordant meal rankings for incremental postprandial glucose in subjects without diabetes. Am J Clin Nutr. 2020 Oct 1;112(4):1114-1119. doi: 10.1093/ajcn/nqaa198.
PubMed 32766882
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Ultra Processed Versus Unprocessed Diets on Energy Intake
- ClinicalTrials.gov ID
- NCT03407053
- Acronym / sponsor ID
- 180044
- Conditions
- Healthy Diet
- Keywords
- Calories, Food Intake, Glucose, Body Composition, Body Weight Regulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)US National Institutes of Health
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 26 Feb 2020 (actual)
- Study completion
- 26 Feb 2020 (actual)
- First posted
- 23 Jan 2018 (actual)
- Results
- Posted 29 Jun 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background:
Eating too much processed food is believed to lead to obesity. But the effect of processed food on energy intake has not been carefully studied. Researchers want to study people s diets for 4 weeks and do specialized tests of the effects. Participants will get two diets. They will have the same calories and nutrients, but one diet will be unprocessed food and the other will be ultra-processed.
Objective:
To better understand how processed and unprocessed foods affect daily food consumption and how the body handles blood sugar.
Eligibility:
Healthy adults ages 18-50 who have stable weight and can exercise
Design:
Participants will not eat for 12 hours. Then they will be screened with:
- Medical history
- Physical exam
- Heart and blood tests
- Resting energy expenditure test (REE). A hood will collect air exhaled while lying down for 30-40 minutes.
- Psychiatric questions
- Questions about mood, eating, sleep, and socioeconomic status
- 20-minute stationary biking
Female participants will have a urine pregnancy test.
Participants will stay in the clinic for 4 weeks. For 2 weeks they will get a processed diet. For the other 2 weeks they will get an unprocessed diet. Participants cannot use the study period to gain or lose weight.
Participants will have:
- Meals and snacks provided
- Daily exercise
- Blood, urine, and saliva tests
- To drink a special water and a very sweet liquid
- REE
- Scans and X-rays
- To wear activity monitors and a device to measure blood sugar
- Several 24-hour periods in a room that measures oxygen and carbon dioxide
- Repeats of screening questions
- Questions about hunger and meals
- Sleep monitoring
- Taste tests
Detailed description
Overconsumption of foods that result from extensive industrial processing is believed to contribute to the development of obesity. Ultra-processed foods now represent most of the calories consumed in America and their contribution to overall diet has increased in parallel with the rise in the prevalence of obesity over the past several decades. While such correlations are suggestive, the effect of industrial processing per se, independent of dietary macronutrient composition, on ad libitum energy intake has not been carefully investigated. Therefore, we will conduct feeding studies in adult men and women to investigate the differences in ad libitum energy intake resulting from consuming test diets for a pair of 2-week periods in a randomized, crossover design during a single 4-week period. The test diets presented to participants will be matched for calories, macronutrient composition, sugar, fiber, and sodium, but one diet will be composed of ultra-processed foods whereas the other diet will be unprocessed foods.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ultra-processed diet then unprocessed diet | Active comparator | Dietary Supplement: Ultra-processed diet, Dietary Supplement: Unprocessed dietParticipants assigned to this arm will consume ultra-processed diet for two weeks followed by unprocessed diet for two weeks |
| Unprocessed diet then ultra-processed diet | Active comparator | Dietary Supplement: Ultra-processed diet, Dietary Supplement: Unprocessed dietParticipants assigned to this arm will consume unprocessed diet for two weeks followed by ultra-processed diet for two weeks |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 4. Body mass index (BMI) greater than or equal to 18 kg/m^2
- 5. Willing to cease their habitual caffeine intake during the study, beginning one week prior to inpatient admission
- 6. Written informed consent
- 7. Willing to eat the food provided in the study
- 8. Able to complete daily bouts of stationary cycling at a moderate rate and intensity with a heart rate (HR) equal to or greater than 0.3x(220-age-HR(rest))+HR(rest) but not exceeding 0.4x(220-age-HR(rest))+HR(rest) and no signs of arrhythmia
Key exclusion criteria (14 listed)
- Evidence of metabolic or cardiovascular disease, or disease that may influence metabolism (e.g. cancer, diabetes, thyroid disease)
- Taking any prescription medication or other drug that may influence metabolism (e.g. diet/weight-loss medication, asthma medication, blood pressure medication, psychiatric medications, corticosteroids, or other medications at the discretion of the PI and/or study team)
- Hematocrit < 34% (women only)
- Hematocrit < 40% (men only)
- Pregnancy, lactation (women only)
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 |
|---|---|---|
| Ultra-processed dietConsuming ultra-processed diet over a 2-week period | Dietary supplement | Ultra-processed diet then unprocessed diet, Unprocessed diet then ultra-processed diet |
| Unprocessed dietConsuming unprocessed diet over a 2-week period | Dietary supplement | Ultra-processed diet then unprocessed diet, Unprocessed diet then ultra-processed diet |
Primary outcome
Ad Libitum Energy Intake
Time frame: 14 days
Ad libitum energy intake averaged over 14 days for each diet, measured in kilocalories (kcal) per day.
2 secondary outcomes
Change in Body Weight
Time frame: Baseline and day 14
Change in Fat Mass
Time frame: Baseline and day 14
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 31105044Hall KD, Ayuketah A, Brychta R, Cai H, Cassimatis T, Chen KY, Chung ST, Costa E, Courville A, Darcey V, Fletcher LA, Forde CG, Gharib AM, Guo J, Howard R, Joseph PV, McGehee S, Ouwerkerk R, Raisinger K, Rozga I, Stagliano M, Walter M, Walter PJ, Yang S, Zhou M. Ultra-Processed Diets Cause Excess Calorie Intake and Weight Gain: An Inpatient Randomized Controlled Trial of Ad Libitum Food Intake. Cell Metab. 2019 Jul 2;30(1):67-77.e3. doi: 10.1016/j.cmet.2019.05.008. Epub 2019 May 16.
- Derived from this study: PubMed 41475551Brunstrom JM, Schatzker M, Rogers PJ, Courville AB, Hall KD, Flynn AN. Consuming an unprocessed diet reduces energy intake: a post-hoc analysis of a randomized controlled trial reveals a role for human nutritional intelligence. Am J Clin Nutr. 2026 Mar;123(3):101183. doi: 10.1016/j.ajcnut.2025.101183. Epub 2025 Dec 29.
- Derived from this study: PubMed 40392756Abar L, Steele EM, Lee SK, Kahle L, Moore SC, Watts E, O'Connell CP, Matthews CE, Herrick KA, Hall KD, O'Connor LE, Freedman ND, Sinha R, Hong HG, Loftfield E. Identification and validation of poly-metabolite scores for diets high in ultra-processed food: An observational study and post-hoc randomized controlled crossover-feeding trial. PLoS Med. 2025 May 20;22(5):e1004560. doi: 10.1371/journal.pmed.1004560. eCollection 2025 May.
- Derived from this study: PubMed 39755436Hengist A, Ong JA, McNeel K, Guo J, Hall KD. Imprecision nutrition? Intraindividual variability of glucose responses to duplicate presented meals in adults without diabetes. Am J Clin Nutr. 2025 Jan;121(1):74-82. doi: 10.1016/j.ajcnut.2024.10.007. Epub 2024 Dec 2.
- Derived from this study: PubMed 39163976Sciarrillo CM, Guo J, Hengist A, Darcey VL, Hall KD. Diet order significantly affects energy balance for diets varying in macronutrients but not ultraprocessing in crossover studies without a washout period. Am J Clin Nutr. 2024 Oct;120(4):953-963. doi: 10.1016/j.ajcnut.2024.08.013. Epub 2024 Aug 18.
- Derived from this study: PubMed 37986904Sciarrillo CM, Guo J, Hengist A, Darcey VL, Hall KD. Diet order affects energy balance in randomized crossover feeding studies that vary in macronutrients but not ultra-processing. medRxiv [Preprint]. 2023 Oct 4:2023.10.03.23296501. doi: 10.1101/2023.10.03.23296501.
- Derived from this study: PubMed 37276937O'Connor LE, Hall KD, Herrick KA, Reedy J, Chung ST, Stagliano M, Courville AB, Sinha R, Freedman ND, Hong HG, Albert PS, Loftfield E. Metabolomic Profiling of an Ultraprocessed Dietary Pattern in a Domiciled Randomized Controlled Crossover Feeding Trial. J Nutr. 2023 Aug;153(8):2181-2192. doi: 10.1016/j.tjnut.2023.06.003. Epub 2023 Jun 3.
- Derived from this study: PubMed 36897799Jaime-Lara RB, Franks AT, Agarwal K, Nawal N, Courville AB, Guo J, Yang S, Brooks BE, Roy A, Taylor K, Darcey VL, LeCheminant JD, Chung S, Forde CG, Hall KD, Joseph PV. No significant salt or sweet taste preference or sensitivity differences following ad libitum consumption of ultra-processed and unprocessed diets: a randomized controlled pilot study. Chem Senses. 2023 Jan 1;48:bjad007. doi: 10.1093/chemse/bjad007.
- Derived from this study: PubMed 32766882Howard R, Guo J, Hall KD. Imprecision nutrition? Different simultaneous continuous glucose monitors provide discordant meal rankings for incremental postprandial glucose in subjects without diabetes. Am J Clin Nutr. 2020 Oct 1;112(4):1114-1119. doi: 10.1093/ajcn/nqaa198.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
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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.
Kevin Hall, Ph.D. principal investigator
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultra-processed diet and Unprocessed diet in people with Healthy Diet, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) 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 7 inclusion and 14 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: finished, as of the sponsor's last update on 29 Jun 2021. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Jun 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Ad Libitum Energy Intake (time frame: 14 days). 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 NCT03407053, which also lists 9 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 29 Jun 2021.