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Completed

NCT Number: NCT03779321

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 At each test day, fasting blood samples were withdrawn by a registered nurse under sterile conditions.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

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Key information

Age range

18 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

About this study

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 At each test day, fasting blood samples were withdrawn by a registered nurse under sterile conditions.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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Acceptability

Other

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

Primary outcomes

  1. Food acceptability

    Time frame: Through study completion, an average of 1 year

    Food acceptability on a 9 point hedonic scale

  2. Ghrelin

    Time frame: Through study completion, an average of 1 year

    Ghrelin levels measured with Enzyme-linked immunosorbent assay (ELISA) kit

  3. GLP-1

    Time frame: Through study completion, an average of 1 year

    GLP-1 levels measured with Enzyme-linked immunosorbent assay (ELISA) kit

  4. Insulin

    Time frame: Through study completion, an average of 1 year

    Insulin levels measured with Enzyme-linked immunosorbent assay (ELISA) kit

  5. Glucose

    Time frame: Through study completion, an average of 1 year

    Glucose levels measured using VITROS ECiQ Immunodiagnostic System

Secondary outcomes

  1. Appetite

    Time frame: Through study completion, an average of 1 year

    Appetite score on the visual analogue scale

  2. Energy intake at the next meal

    Time frame: Through study completion, an average of 1 year

    Measuring quantity of cheese pizza consumed

Sponsors and collaborators

Lead sponsor

American University of Beirut Medical Center

Other

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Dec 19, 2018
Registry last updated
Dec 20, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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