Effect of Food Acceptability on Appetite Hormones' Response in Normal Weight vs. Obese Male Subjects

Study Overview
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Brief Summary
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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 At each test day, fasting blood samples were withdrawn by a registered nurse under sterile conditions.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
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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 At each test day, fasting blood samples were withdrawn by a registered nurse under sterile conditions.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.

Official Title
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Effect of Food Acceptability on Appetite Hormones' Response in Normal Weight vs. Obese Male Subjects

Conditions
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Eating Behavior

Intervention / Treatment
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* Other: Acceptability


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Lean panelists<br>Lean panelists or normal weight panelists with a BMI between 18.5 and 24.9 Acceptability was assessed | Other: Acceptability<br>* Food samples two formulations (low and high acceptability levels) of custard were used as experimental meals<br>|
| Other: Obese panelists<br>Obese panelists with a BMI between 25 and 29.9 Acceptability was assessed | Other: Acceptability<br>* Food samples two formulations (low and high acceptability levels) of custard were used as experimental meals<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Food acceptability | Food acceptability on a 9 point hedonic scale | Through study completion, an average of 1 year | 
| Ghrelin | Ghrelin levels measured with Enzyme-linked immunosorbent assay (ELISA) kit | Through study completion, an average of 1 year | 
| GLP-1 | GLP-1 levels measured with Enzyme-linked immunosorbent assay (ELISA) kit | Through study completion, an average of 1 year | 
| Insulin | Insulin levels measured with Enzyme-linked immunosorbent assay (ELISA) kit | Through study completion, an average of 1 year | 
| Glucose | Glucose levels measured using VITROS ECiQ Immunodiagnostic System | Through study completion, an average of 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Appetite | Appetite score on the visual analogue scale | Through study completion, an average of 1 year | 
| Energy intake at the next meal | Measuring quantity of cheese pizza consumed | Through study completion, an average of 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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food, acceptability, appetite, hormones, ghrelin, GLP-1