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

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 At each test day, fasting blood samples were withdrawn by a registered nurse under sterile conditions.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

Study Overview

• Status: Completed
• Conditions: Eating Behavior
• Intervention / Treatment: Other: Acceptability

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 At each test day, fasting blood samples were withdrawn by a registered nurse under sterile conditions.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 Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: NON_RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: American University of Beirut Medical Center

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 1, 2016
• Primary Completion (ACTUAL): July 1, 2017
• Study Completion (ACTUAL): September 30, 2017

Study Registration Dates

• First Submitted: December 6, 2018
• First Submitted That Met QC Criteria: December 17, 2018
• First Posted (ACTUAL): December 19, 2018

Study Record Updates

• Last Update Posted (ACTUAL): December 20, 2018
• Last Update Submitted That Met QC Criteria: December 19, 2018
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Keywords: food, acceptability, appetite, hormones, ghrelin, GLP-1
• Other Study ID Numbers: NUT.AO.20

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No