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

Overview

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 At each test day, fasting blood samples were withdrawn by a registered nurse under sterile conditions.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

Full Title of Study: “Effect of Food Acceptability on Appetite Hormones’ Response in Normal Weight vs. Obese Male Subjects”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Other
    • Masking: None (Open Label)
  • Study Primary Completion Date: July 1, 2017

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 At each test day, fasting blood samples were withdrawn by a registered nurse under sterile conditions.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

Interventions

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

Arms, Groups and Cohorts

  • Other: Lean panelists
    • Lean panelists or normal weight panelists with a BMI between 18.5 and 24.9 Acceptability was assessed
  • Other: Obese panelists
    • Obese panelists with a BMI between 25 and 29.9 Acceptability was assessed

Clinical Trial Outcome Measures

Primary Measures

  • 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

Secondary Measures

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

Participating in This Clinical Trial

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)

Gender Eligibility: Male

Minimum Age: 18 Years

Maximum Age: 50 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • American University of Beirut Medical Center
  • Provider of Information About this Clinical Study
    • Principal Investigator: Ammar Olabi, Professor – American University of Beirut Medical Center

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