ObeseNCT01550133
Effects of Food Form on Cephalic Phase Responses
A study testing Learned: Non-nutritive beverage to Non-nutritive beverage, Learned: Nutritive solid to Nutritive solid and Learned: Nutritive beverage to Nutritive beverage in people with Obese and Overweight, run by Purdue University at 1 site in United States.
Trial summary
This study has two main aims: 1) To determine if ingestion of solid or beverage food forms will change appetite hormone responses, and 2) To determine whether "learning" (defined as 2 week daily consumption) about the metabolic consequence of ingesting solid or beverage foods forms varying in energy alters appetite… Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Obese, Overweight
- What is being tested?
- Learned: Non-nutritive beverage to Non-nutritive beverage, Learned: Nutritive solid to Nutritive solid and Learned: Nutritive beverage to Nutritive beverage
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2012to 30 Dec 2016
- Phase
- Interventional
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Body fat percentage > 25% for men and > 32% for women. BMI of 24 kg/m2- 37kg/m2
- No purposeful use of foods or beverages that are sweetened with non-nutritive sweetener > 3 times a week
- No purposeful addition of non-nutritive sweetener to foods and beverages >3 times a week
- No Phenylketonuria (PKU)
- Rate palatability of test load and food sample as greater than 5 on a 9 point category scale.
- Be willing to eat at least 100 grams of carbohydrates for three days prior to each test day
Show all 17Show fewer
- Self-reported consumer of breakfast and lunch
- Be willing to eat macaroni and cheese during breakfast-lunch hours
- Not taking medications known to influence appetite
- Non-smoker >1 year or more
- Habitual activity pattern over the last 3 months and no plan to change this over the course of the study
- Not on any extreme diet (e.g. Atkins Diet)
- Weight stable (≤ 5 kg change over the last 3 months)
- Not a restrained eater (have a dietary restraint score of <9 on the Three Factor Eating Questionnaire-Restraint section)
- Not a disordered eater (Have a score of <20 in the Eating Attitudes Test-26)
- Have not donated blood for at least 3 months prior to participating in the study
- Indicate no plan to donate blood during, and for three months after the study
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Nutritive and Non-Nutritive Food Form and Learning on Cephalic Phase Responses
This study has two main aims: 1) To determine if ingestion of solid or beverage food forms will change appetite hormone responses, and 2) To determine whether "learning" (defined as 2 week daily consumption) about the metabolic consequence of ingesting solid or beverage foods forms varying in energy alters appetite hormone responses.
Beverage consumption has been implicated in the problem of obesity. However, the exact relationship between beverages, lower appetitive response and lower compensatory dietary responses remains unclear. This study aims to address this gap in the research. For aim 1, the null hypothesis is that the energy in beverage and solid forms will not affect appetite hormonal responses differently. The alternative hypothesis is that exposure to the energy-yielding beverage will elicit a lower appetitive hormone response compared to oral exposure to the solid food form. For aim 2, the null hypothesis is that learning will not change appetite hormone responses. The alternative hypothesis is that learning will decrease appetite hormone responses in the non-energy-yielding beverage more than in the energy-yielding beverage.
Read the detailed description
The main aims will be studied in 3 phases. In phase 1,the unconditioned cephalic phase responses of participants to nutritive and non-nutritive beverage and solid food forms will be determined. In phase 2, participants will consume a randomly allocated solid food or beverage (either nutritive or non-nutritive) consecutively for 2 weeks. In phase 3, (which will occur immediately after the end of Phase 2), participants will be retested for their cephalic phase responses to determine if there is an effect of learning on appetite hormone response.
- Conditions
- Obese, Overweight
- Being tested
- Learned: Non-nutritive beverage to Non-nutritive beverage, Learned: Nutritive solid to Nutritive solid, Learned: Nutritive beverage to Nutritive beverage, Not Learned: Non-nutritive solid to Nutritive solid, Not Learned: Nutritive beverage to Non-nutritive beverage
- Keywords
- Peptides, Hormones, Appetite, Humans, Obese, Beverage, Solid food, cephalic phase
- Medical subject headings
- Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Learned: Non-nutritive beverage to Non-nutritive beverageBehavioural
Also called NNB to NNB
For the learning phase of the experiment, random allocation will assign about 15 participants to consume a beverage product made with non-nutritive sweetener everyday for two weeks.Half of these participants will then be tested against a non-nutritive beverage.
Learned: Nutritive solid to Nutritive solidBehavioural
Also called NS to NS
For the learning phase of the experiment, random allocation will assign about 15 participants to consume a solid food product made with nutritive sweetener everyday for two weeks. Half of these participants will then be tested against a nutritive solid.
Learned: Nutritive beverage to Nutritive beverageBehavioural
Also called NB to NB
For the learning phase of the experiment, random allocation will assign about 15 participants to consume a beverage product made with nutritive sweetener everyday for two weeks. Half of these participants will then be tested against a nutritive beverage.
Not Learned: Non-nutritive solid to Nutritive solidBehavioural
Also called NNS to NS
For the learning phase of the experiment, random allocation will assign about 15 participants to consume a solid food product made with non-nutritive sweetener everyday for two weeks. Half of these participants will then be tested against a nutritive solid.
Not Learned: Nutritive beverage to Non-nutritive beverageBehavioural
Also called NB to NNB
For the learning phase of the experiment, random allocation will assign about 15 participants to consume a beverage food product made with nutritive sweetener everyday for two weeks. Half of these participants will then be tested against a non-nutritive beverage.
Not Learned: Non-Nutritive solid to Non-nutritive solidBehavioural
Also called NS to NNS
For the learning phase of the experiment, random allocation will assign about 15 participants to consume a solid food product made with nutritive sweetener everyday for two weeks. Half of these participants will then be tested against a non-nutritive solid.
Not Learned: Non-nutritive beverage to Nutritive beverageBehavioural
Also called NNB to NB
For the learning phase of the experiment, random allocation will assign about 15 participants to consume a beverage food product made with non-nutritive sweetener everyday for two weeks. Half of these participants will then be tested against a nutritive beverage.
Not Learned: Non-Nutritive solid to Non-Nutritive SolidBehavioural
Also called NNS to NNS
For the learning phase of the experiment, random allocation will assign about 15 participants to consume a solid food product made with non-nutritive sweetener everyday for two weeks. Half of these participants will then be tested against a non-nutritive solid.
| Study group | Role | What they receive |
|---|---|---|
| Not Learned: Non-nutritive bev to Nutritive bev | Experimental | 15 participants will be randomly assigned to eat 250 grams of non-nutritive solid consecutively for 2 weeks. After this conditioning, the cephalic phase response of half of these participants will be tested against a nutritive solid and act as a control for the learned effects. Receives: Behavioral: Learned: Non-nutritive beverage to Non-nutritive beverage |
| Not Learned: Nutritive solid to Non-Nutritive solid | Experimental | 15 participants will be randomly assigned to eat 250 grams of nutritive solid consecutively for 2 weeks. After this conditioning, the cephalic phase response of half of these participants will be tested against a non-nutritive solid and act as a control for the learned effects. Receives: Behavioral: Learned: Nutritive solid to Nutritive solid |
| Not Learned: Nutritive beverage to Non-Nutritive beverage | Experimental | 15 participants will be randomly assigned to drink 400 grams of nutritive beverage consecutively for 2 weeks. After this conditioning, the cephalic phase response of half of these participants will be tested against a non-nutritive beverage and act as a control for the learned effects. Receives: Behavioral: Learned: Nutritive beverage to Nutritive beverage |
| Learned: Non-Nutritive solid to Non-Nutritive solid | Experimental | 15 participants will be randomly assigned to eat 250 grams of non-nutritive solid consecutively for 2 weeks. After this conditioning, the cephalic phase response of half of these participants will be tested against a non-nutritive solid to determine if cephalic phase response changes with learning. Receives: Behavioral: Not Learned: Non-nutritive solid to Nutritive solid |
| Learned: Non-Nutritive beverage to Non-Nutritive beverage | Experimental | 15 participants will be randomly assigned to drink 400 grams of non-nutritive beverage consecutively for 2 weeks. After this conditioning, the cephalic phase response of half of these participants will be tested against a non-nutritive beverage to determine if cephalic phase response changes with learning. Receives: Behavioral: Not Learned: Nutritive beverage to Non-nutritive beverage |
| Learned: Nutritive solid to Nutritive solid | Experimental | 15 participants will be randomly assigned to eat 250 grams of nutritive solid consecutively for 2 weeks. After this conditioning, the cephalic phase response of half of these participants will be tested against a nutritive solid to determine if cephalic phase response changes with learning. Receives: Behavioral: Not Learned: Non-Nutritive solid to Non-nutritive solid |
| Learned: Nutritive beverage to Nutritive beverage | Experimental | 15 participants will be randomly assigned to drink 400 grams of nutritive beverage consecutively for 2 weeks. After this conditioning, the cephalic phase response of half of these participants will be tested against a nutritive beverage to determine if cephalic phase response changes with learning. Receives: Behavioral: Not Learned: Non-nutritive beverage to Nutritive beverage |
| Not Learned: Non-Nutritive solid to Non-Nutritive solid | Experimental | 15 participants will be randomly assigned to eat 250 grams of non-nutritive solid consecutively for 2 weeks. After this conditioning, the cephalic phase response of half of these participants will be tested against a non-nutritive solid to determine if cephalic phase response changes with learning. Receives: Behavioral: Not Learned: Non-Nutritive solid to Non-Nutritive Solid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Appetite Hormone Response
Determine the appetite hormone responses to oral exposure of nutritive (energy-yielding) or non-nutritive (non-energy-yielding) sweetener in beverage or solid form. Then, determine whether the appetite hormone responses change after a 2-week learning period.
Appetite hormones to be measured: Cholecystokinin, Glucagon-Like-Peptide-1, Ghrelin, Insulin, Pancreatic Polypeptide
Measured: week 1, week 2, week 3, week 4, week 7, week 8, week 9, week 10 (once a week over 136 minutes: 0, 14, 16, 18, 20, 22, 24, 26, 28, 30, 76, 106, 136 minutes)
Secondary outcomes (3)
Change in Appetite
Determining changes in appetite ratings with oral exposure to nutritive or non-nutritive sweetener in beverage or solid food form and lastly with a meal.
Measured: week 1, week 2, week 3, week 4, week 7, week 8, week 9, week 10 (once a week, over 180 minutes: 0, 14, 30, 76, 106, 136, 180 minutes)
Plasma Glucose
Determine the differences in plasma glucose concentration after oral exposure to nutritive or non-nutritive sweetener in beverage or solid food forms and whether there are changes after a 2-week learning period.
Measured: week 1, week 2, week 3, week 4, week 7, week 8, week 9, week 10 (once a week, over 136 minutes: 0, 14, 16, 18, 20, 22, 24, 26, 28, 30, 76, 106, 136 minutes)
Amount of meal ingested
Amount of meal ingested will be determined by presenting a pre-weighted meal and water to the participant at 137 minutes. The meal will be provided in excess of an amount that can be consumed. Participants are asked to eat until comfortably full. The amount ingested will be determined by covertly re-weighing the amount remaining.
Measured: week 1, week 2, week 3, week 4, week 7, week 8, week 9, week 10 (once a week, at 137 minutes to 180 minutes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2012 (estimated)
- Study start1 Sep 2012
- Primary completion30 Apr 2016
- Study completion30 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObeseStudies of the same condition, open and under way.
- 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Purdue University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Richard Mattes, Purdue University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01550133
- Sponsor's protocol ID
- R01DK079913-4
- Other IDs
- R01DK079913, 1201011780
- Status last verified
- Dec 2023
- First submitted
- 7 Mar 2012
- Last updated
- 12 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Nutritive and Non-Nutritive Food Form and Learning on Cephalic Phase Responses
- ClinicalTrials.gov ID
- NCT01550133
- Acronym / sponsor ID
- R01DK079913-4
- Conditions
- Obese, Overweight
- Keywords
- Peptides, Hormones, Appetite, Humans, Obese, Beverage, Solid food, cephalic phase
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Purdue UniversityUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 1 Sep 2012 (actual)
- Primary completion
- 30 Apr 2016 (actual)
- Study completion
- 30 Dec 2016 (actual)
- First posted
- 9 Mar 2012 (estimated)
- 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.
This study has two main aims: 1) To determine if ingestion of solid or beverage food forms will change appetite hormone responses, and 2) To determine whether "learning" (defined as 2 week daily consumption) about the metabolic consequence of ingesting solid or beverage foods forms varying in energy alters appetite hormone responses.
Beverage consumption has been implicated in the problem of obesity. However, the exact relationship between beverages, lower appetitive response and lower compensatory dietary responses remains unclear. This study aims to address this gap in the research. For aim 1, the null hypothesis is that the energy in beverage and solid forms will not affect appetite hormonal responses differently. The alternative hypothesis is that exposure to the energy-yielding beverage will elicit a lower appetitive hormone response compared to oral exposure to the solid food form. For aim 2, the null hypothesis is that learning will not change appetite hormone responses. The alternative hypothesis is that learning will decrease appetite hormone responses in the non-energy-yielding beverage more than in the energy-yielding beverage.
Detailed description
The main aims will be studied in 3 phases. In phase 1,the unconditioned cephalic phase responses of participants to nutritive and non-nutritive beverage and solid food forms will be determined. In phase 2, participants will consume a randomly allocated solid food or beverage (either nutritive or non-nutritive) consecutively for 2 weeks. In phase 3, (which will occur immediately after the end of Phase 2), participants will be retested for their cephalic phase responses to determine if there is an effect of learning on appetite hormone response.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Not Learned: Non-nutritive bev to Nutritive bev | Experimental | Behavioral: Learned: Non-nutritive beverage to Non-nutritive beverage15 participants will be randomly assigned to eat 250 grams of non-nutritive solid consecutively for 2 weeks. After this conditioning, the cephalic phase response of half of these participants will be tested against a nutritive solid and act as a control for the learned effects. |
| Not Learned: Nutritive solid to Non-Nutritive solid | Experimental | Behavioral: Learned: Nutritive solid to Nutritive solid15 participants will be randomly assigned to eat 250 grams of nutritive solid consecutively for 2 weeks. After this conditioning, the cephalic phase response of half of these participants will be tested against a non-nutritive solid and act as a control for the learned effects. |
| Not Learned: Nutritive beverage to Non-Nutritive beverage | Experimental | Behavioral: Learned: Nutritive beverage to Nutritive beverage15 participants will be randomly assigned to drink 400 grams of nutritive beverage consecutively for 2 weeks. After this conditioning, the cephalic phase response of half of these participants will be tested against a non-nutritive beverage and act as a control for the learned effects. |
| Learned: Non-Nutritive solid to Non-Nutritive solid | Experimental | Behavioral: Not Learned: Non-nutritive solid to Nutritive solid15 participants will be randomly assigned to eat 250 grams of non-nutritive solid consecutively for 2 weeks. After this conditioning, the cephalic phase response of half of these participants will be tested against a non-nutritive solid to determine if cephalic phase response changes with learning. |
| Learned: Non-Nutritive beverage to Non-Nutritive beverage | Experimental | Behavioral: Not Learned: Nutritive beverage to Non-nutritive beverage15 participants will be randomly assigned to drink 400 grams of non-nutritive beverage consecutively for 2 weeks. After this conditioning, the cephalic phase response of half of these participants will be tested against a non-nutritive beverage to determine if cephalic phase response changes with learning. |
| Learned: Nutritive solid to Nutritive solid | Experimental | Behavioral: Not Learned: Non-Nutritive solid to Non-nutritive solid15 participants will be randomly assigned to eat 250 grams of nutritive solid consecutively for 2 weeks. After this conditioning, the cephalic phase response of half of these participants will be tested against a nutritive solid to determine if cephalic phase response changes with learning. |
| Learned: Nutritive beverage to Nutritive beverage | Experimental | Behavioral: Not Learned: Non-nutritive beverage to Nutritive beverage15 participants will be randomly assigned to drink 400 grams of nutritive beverage consecutively for 2 weeks. After this conditioning, the cephalic phase response of half of these participants will be tested against a nutritive beverage to determine if cephalic phase response changes with learning. |
| Not Learned: Non-Nutritive solid to Non-Nutritive solid | Experimental | Behavioral: Not Learned: Non-Nutritive solid to Non-Nutritive Solid15 participants will be randomly assigned to eat 250 grams of non-nutritive solid consecutively for 2 weeks. After this conditioning, the cephalic phase response of half of these participants will be tested against a non-nutritive solid to determine if cephalic phase response changes with learning. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (17 listed)
- Body fat percentage > 25% for men and > 32% for women. BMI of 24 kg/m2- 37kg/m2
- No purposeful use of foods or beverages that are sweetened with non-nutritive sweetener > 3 times a week
- No purposeful addition of non-nutritive sweetener to foods and beverages >3 times a week
- No Phenylketonuria (PKU)
- Rate palatability of test load and food sample as greater than 5 on a 9 point category scale.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Learned: Non-nutritive beverage to Non-nutritive beverageAlso: NNB to NNBFor the learning phase of the experiment, random allocation will assign about 15 participants to consume a beverage product made with non-nutritive sweetener everyday for two weeks.Half of these participants will then be tested against a non-nutritive beverage. | Behavioural | Not Learned: Non-nutritive bev to Nutritive bev |
| Learned: Nutritive solid to Nutritive solidAlso: NS to NSFor the learning phase of the experiment, random allocation will assign about 15 participants to consume a solid food product made with nutritive sweetener everyday for two weeks. Half of these participants will then be tested against a nutritive solid. | Behavioural | Not Learned: Nutritive solid to Non-Nutritive solid |
| Learned: Nutritive beverage to Nutritive beverageAlso: NB to NBFor the learning phase of the experiment, random allocation will assign about 15 participants to consume a beverage product made with nutritive sweetener everyday for two weeks. Half of these participants will then be tested against a nutritive beverage. | Behavioural | Not Learned: Nutritive beverage to Non-Nutritive beverage |
| Not Learned: Non-nutritive solid to Nutritive solidAlso: NNS to NSFor the learning phase of the experiment, random allocation will assign about 15 participants to consume a solid food product made with non-nutritive sweetener everyday for two weeks. Half of these participants will then be tested against a nutritive solid. | Behavioural | Learned: Non-Nutritive solid to Non-Nutritive solid |
| Not Learned: Nutritive beverage to Non-nutritive beverageAlso: NB to NNBFor the learning phase of the experiment, random allocation will assign about 15 participants to consume a beverage food product made with nutritive sweetener everyday for two weeks. Half of these participants will then be tested against a non-nutritive beverage. | Behavioural | Learned: Non-Nutritive beverage to Non-Nutritive beverage |
| Not Learned: Non-Nutritive solid to Non-nutritive solidAlso: NS to NNSFor the learning phase of the experiment, random allocation will assign about 15 participants to consume a solid food product made with nutritive sweetener everyday for two weeks. Half of these participants will then be tested against a non-nutritive solid. | Behavioural | Learned: Nutritive solid to Nutritive solid |
| Not Learned: Non-nutritive beverage to Nutritive beverageAlso: NNB to NBFor the learning phase of the experiment, random allocation will assign about 15 participants to consume a beverage food product made with non-nutritive sweetener everyday for two weeks. Half of these participants will then be tested against a nutritive beverage. | Behavioural | Learned: Nutritive beverage to Nutritive beverage |
| Not Learned: Non-Nutritive solid to Non-Nutritive SolidAlso: NNS to NNSFor the learning phase of the experiment, random allocation will assign about 15 participants to consume a solid food product made with non-nutritive sweetener everyday for two weeks. Half of these participants will then be tested against a non-nutritive solid. | Behavioural | Not Learned: Non-Nutritive solid to Non-Nutritive solid |
Primary outcome
Appetite Hormone Response
Time frame: week 1, week 2, week 3, week 4, week 7, week 8, week 9, week 10 (once a week over 136 minutes: 0, 14, 16, 18, 20, 22, 24, 26, 28, 30, 76, 106, 136 minutes)
Determine the appetite hormone responses to oral exposure of nutritive (energy-yielding) or non-nutritive (non-energy-yielding) sweetener in beverage or solid form. Then, determine whether the appetite hormone responses change after a 2-week learning period. Appetite hormones to be measured: Cholecystokinin, Glucagon-Like-Peptide-1, Ghrelin, Insulin, Pancreatic Polypeptide
3 secondary outcomes
Change in Appetite
Time frame: week 1, week 2, week 3, week 4, week 7, week 8, week 9, week 10 (once a week, over 180 minutes: 0, 14, 30, 76, 106, 136, 180 minutes)
Plasma Glucose
Time frame: week 1, week 2, week 3, week 4, week 7, week 8, week 9, week 10 (once a week, over 136 minutes: 0, 14, 16, 18, 20, 22, 24, 26, 28, 30, 76, 106, 136 minutes)
Amount of meal ingested
Time frame: week 1, week 2, week 3, week 4, week 7, week 8, week 9, week 10 (once a week, at 137 minutes to 180 minutes)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2023.
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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.
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 study testing Learned: Non-nutritive beverage to Non-nutritive beverage, Learned: Nutritive solid to Nutritive solid and Learned: Nutritive beverage to Nutritive beverage in people with Obese and Overweight, run by Purdue 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 17 inclusion and 0 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 12 Dec 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Appetite Hormone Response (time frame: week 1, week 2, week 3, week 4, week 7, week 8, week 9, week 10 (once a week over 136 minutes: 0, 14, 16, 18, 20, 22, 24, 26, 28, 30, 76, 106, 136 minutes)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Dec 2023.