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

NCT03779321 | Completed DMC

• 1 other identifier: NUT.AO.20
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

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 At each test day, fasting blood samples were withdrawn by a registered nurse under sterile conditions.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

Conditions

Eating Behavior

Keywords

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

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (2)

• Appetite

  Through study completion, an average of 1 year

• Energy intake at the next meal

  Through study completion, an average of 1 year

Study Arms (2)

Lean panelists

OTHER

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

Other: Acceptability

Obese panelists

OTHER

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

Other: Acceptability

Interventions

Acceptability OTHER

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

Lean panelists; Obese panelists

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• American University of Beirut Medical Center: lead

Related Publications (1)

• 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.

  PMID: 31411376 DERIVED

MeSH Terms

Conditions

Feeding Behavior

Condition Hierarchy (Ancestors)

Behavior, Animal; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 6, 2018
• First Posted: December 19, 2018
• Study Start: September 1, 2016
• Primary Completion: July 1, 2017
• Study Completion: September 30, 2017
• Last Updated: December 20, 2018

Record last verified: 2018-12

Data Sharing

• IPD Sharing: Will not share