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

NCT ID: NCT03779321

Last Updated: 2018-12-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-09-01
• Study Completion Date: 2017-09-30

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 At each test day, fasting blood samples were withdrawn by a registered nurse under sterile conditions.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 At each test day, fasting blood samples were withdrawn by a registered nurse under sterile conditions.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

Conditions

Eating Behavior

Keywords

food, acceptability, appetite, hormones, ghrelin, GLP-1

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Lean panelists

Lean panelists or normal weight panelists with a BMI between 18.5 and 24.9 Acceptability was assessed

Group Type: OTHER

Acceptability

Intervention Type: OTHER

Food samples two formulations (low and high acceptability levels) of custard were used as experimental meals

Obese panelists

Obese panelists with a BMI between 25 and 29.9 Acceptability was assessed

Group Type: OTHER

Acceptability

Intervention Type: OTHER

Food samples two formulations (low and high acceptability levels) of custard were used as experimental meals

Interventions

Acceptability

Food samples two formulations (low and high acceptability levels) of custard were used as experimental meals

Intervention Type: OTHER

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

American University of Beirut Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Ammar Olabi

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

References

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.

Reference Type: DERIVED

PMID: 31411376 (View on PubMed)

Other Identifiers

NUT.AO.20

Identifier Type: -

Identifier Source: org_study_id