Eating BehaviorNCT03779321
Effect of Food Acceptability on Appetite Hormones' Response in Normal Weight vs. Obese Male Subjects
A study testing Acceptability in people with Eating Behavior, run by American University of Beirut Medical Center.
Trial summary
Male subjects with specific body characteristics were recruited for the study. Subjects did an acceptability test on custard and completed a screening questionnaire. Around 30 subjects (15 with a normal BMI and 15 obese) continued the study. Read more about this study
- Who is it for?
- Ages 18 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Eating Behavior
- What is being tested?
- Acceptability
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2016to 30 Sep 2017
- 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
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Gender: Male
- Age: 18-50 years
- Body Mass Index (BMI): 18.5-24.9 kg/m2 or 30-39.9 kg/m2
- Stable body weight for at least three months before the study with the absence of any form of dieting, food restriction or other abnormal eating behaviors (to minimize the effect of weight change on ghrelin and GLP-1 statuses)
- Agreement on the acceptability levels of the two versions (high and low acceptability) of custard
Who cannot join
- Smoking
- Substance abuse such as alcohol or drugs
- Medical or psychological illness
- Previous gastrointestinal surgery
- History of weight fluctuation (weight loss of greater than 5% within the past 3 months)
About this study
Male subjects with specific body characteristics were recruited for the study. Subjects did an acceptability test on custard and completed a screening questionnaire. Around 30 subjects (15 with a normal BMI and 15 obese) continued the study. At each test day, fasting blood samples were withdrawn by a registered nurse under sterile conditions. This procedure was followed by ingestion of one of the two meals within a period of 10-15 minutes. Blood samples of 5 ml were collected at fasting and after ingestion of meals. At the end, subjects were given ad lib access to cheese pizza to assess energy intake after the custard preload. Blood analysis for GLP-1, ghrelin, insulin and glucose levels were performed.
Read the detailed description
Male subjects were recruited for the study based on the following criteria: age between 18 and 50, body mass index normal or obese, non-smokers, non-alcoholic, and do not take medications. Subjects did an acceptability test on custard and completed a screening questionnaire. Around 30 subjects (15 with a normal BMI and 15 obese) continued the study. Subjects were randomly assigned to one of two meals. Each of the two meals was ingested after a 3-day adaptation period. The meals had similar macronutrient composition and provided energy equivalent to 30% of the subjects' resting energy expenditure. At each test day, fasting blood samples were withdrawn by a registered nurse under sterile conditions. This procedure was followed by ingestion of one of the two meals within a period of 10-15 minutes. Blood samples of 5 ml were collected at fasting and after ingestion of meals at 15, 30, 60, 120, 180 and 240 minutes. At the end, subjects were given ad lib access to cheese pizza to assess energy intake after the custard preload. Blood analysis for GLP-1, ghrelin, insulin and glucose levels were performed.
- Conditions
- Eating Behavior
- Being tested
- Acceptability
- Keywords
- food, acceptability, appetite, hormones, ghrelin, GLP-1
- Medical subject headings
- Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcceptabilityOther
Food samples two formulations (low and high acceptability levels) of custard were used as experimental meals
| Study group | Role | What they receive |
|---|---|---|
| Lean panelists | Other | Lean panelists or normal weight panelists with a BMI between 18.5 and 24.9 Acceptability was assessed Receives: Other: Acceptability |
| Obese panelists | Other | Obese panelists with a BMI between 25 and 29.9 Acceptability was assessed Receives: Other: Acceptability |
What is being measured
The primary outcome is the main question the study is designed to answer.
Food acceptability
Food acceptability on a 9 point hedonic scale
Measured: Through study completion, an average of 1 year
Ghrelin
Ghrelin levels measured with Enzyme-linked immunosorbent assay (ELISA) kit
Measured: Through study completion, an average of 1 year
GLP-1
GLP-1 levels measured with Enzyme-linked immunosorbent assay (ELISA) kit
Measured: Through study completion, an average of 1 year
Insulin
Insulin levels measured with Enzyme-linked immunosorbent assay (ELISA) kit
Measured: Through study completion, an average of 1 year
Glucose
Glucose levels measured using VITROS ECiQ Immunodiagnostic System
Measured: Through study completion, an average of 1 year
Secondary outcomes (2)
Appetite
Appetite score on the visual analogue scale
Measured: Through study completion, an average of 1 year
Energy intake at the next meal
Measuring quantity of cheese pizza consumed
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2018
- Study start1 Sep 2016
- Primary completion1 Jul 2017
- Study completion30 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Eating BehaviorStudies 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- American University of Beirut Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ammar Olabi, American University of Beirut Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03779321
- Sponsor's protocol ID
- NUT.AO.20
- Status last verified
- Dec 2018
- First submitted
- 6 Dec 2018
- Last updated
- 20 Dec 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
El Helou N, Obeid OA, Olabi A. Effect of Meal Acceptability on Postprandial Appetite Scores and Hormones of Male Participants with Varied Adiposity. Obesity (Silver Spring). 2019 Oct;27(10):1627-1633. doi: 10.1002/oby.22583. Epub 2019 Aug 14.
PubMed 31411376
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Food Acceptability on Appetite Hormones' Response in Normal Weight vs. Obese Male Subjects
- ClinicalTrials.gov ID
- NCT03779321
- Acronym / sponsor ID
- NUT.AO.20
- Conditions
- Eating Behavior
- Keywords
- food, acceptability, appetite, hormones, ghrelin, GLP-1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- American University of Beirut Medical CenterUniversity, hospital or other
- Study start
- 1 Sep 2016 (actual)
- Primary completion
- 1 Jul 2017 (actual)
- Study completion
- 30 Sep 2017 (actual)
- First posted
- 19 Dec 2018 (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.
Male subjects with specific body characteristics were recruited for the study. Subjects did an acceptability test on custard and completed a screening questionnaire. Around 30 subjects (15 with a normal BMI and 15 obese) continued the study. At each test day, fasting blood samples were withdrawn by a registered nurse under sterile conditions. This procedure was followed by ingestion of one of the two meals within a period of 10-15 minutes. Blood samples of 5 ml were collected at fasting and after ingestion of meals. At the end, subjects were given ad lib access to cheese pizza to assess energy intake after the custard preload. Blood analysis for GLP-1, ghrelin, insulin and glucose levels were performed.
Detailed description
Male subjects were recruited for the study based on the following criteria: age between 18 and 50, body mass index normal or obese, non-smokers, non-alcoholic, and do not take medications. Subjects did an acceptability test on custard and completed a screening questionnaire. Around 30 subjects (15 with a normal BMI and 15 obese) continued the study. Subjects were randomly assigned to one of two meals. Each of the two meals was ingested after a 3-day adaptation period. The meals had similar macronutrient composition and provided energy equivalent to 30% of the subjects' resting energy expenditure. At each test day, fasting blood samples were withdrawn by a registered nurse under sterile conditions. This procedure was followed by ingestion of one of the two meals within a period of 10-15 minutes. Blood samples of 5 ml were collected at fasting and after ingestion of meals at 15, 30, 60, 120, 180 and 240 minutes. At the end, subjects were given ad lib access to cheese pizza to assess energy intake after the custard preload. Blood analysis for GLP-1, ghrelin, insulin and glucose levels were performed.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lean panelists | Other | Other: AcceptabilityLean panelists or normal weight panelists with a BMI between 18.5 and 24.9 Acceptability was assessed |
| Obese panelists | Other | Other: AcceptabilityObese panelists with a BMI between 25 and 29.9 Acceptability was assessed |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Gender: Male
- Age: 18-50 years
- Body Mass Index (BMI): 18.5-24.9 kg/m2 or 30-39.9 kg/m2
- Stable body weight for at least three months before the study with the absence of any form of dieting, food restriction or other abnormal eating behaviors (to minimize the effect of weight change on ghrelin and GLP-1 statuses)
- Agreement on the acceptability levels of the two versions (high and low acceptability) of custard
Key exclusion criteria (5 listed)
- Smoking
- Substance abuse such as alcohol or drugs
- Medical or psychological illness
- Previous gastrointestinal surgery
- History of weight fluctuation (weight loss of greater than 5% within the past 3 months)
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 |
|---|---|---|
| AcceptabilityFood samples two formulations (low and high acceptability levels) of custard were used as experimental meals | Other | Lean panelists, Obese panelists |
Primary outcome
Food acceptability
Time frame: Through study completion, an average of 1 year
Food acceptability on a 9 point hedonic scale
Ghrelin
Time frame: Through study completion, an average of 1 year
Ghrelin levels measured with Enzyme-linked immunosorbent assay (ELISA) kit
GLP-1
Time frame: Through study completion, an average of 1 year
GLP-1 levels measured with Enzyme-linked immunosorbent assay (ELISA) kit
Insulin
Time frame: Through study completion, an average of 1 year
Insulin levels measured with Enzyme-linked immunosorbent assay (ELISA) kit
Glucose
Time frame: Through study completion, an average of 1 year
Glucose levels measured using VITROS ECiQ Immunodiagnostic System
2 secondary outcomes
Appetite
Time frame: Through study completion, an average of 1 year
Energy intake at the next meal
Time frame: Through study completion, an average of 1 year
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 20 Dec 2018.
- Derived from this study: PubMed 31411376El Helou N, Obeid OA, Olabi A. Effect of Meal Acceptability on Postprandial Appetite Scores and Hormones of Male Participants with Varied Adiposity. Obesity (Silver Spring). 2019 Oct;27(10):1627-1633. doi: 10.1002/oby.22583. Epub 2019 Aug 14.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Acceptability in people with Eating Behavior, run by American University of Beirut Medical Center.
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 5 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 20 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Food acceptability (time frame: Through study completion, an average of 1 year). The study lists 5 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 NCT03779321, which also lists 1 linked publication.
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 20 Dec 2018.