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

Eating Behavior Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03779321
• Other study ID #: NUT.AO.20
• Status: Completed
• Phase: N/A
• Start date: September 1, 2016
• Est. completion date: September 30, 2017

Study information

• Verified date: December 2018
• Source: American University of Beirut Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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 At each test day, fasting blood samples were withdrawn by a registered nurse under sterile conditions.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

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 At each test day, fasting blood samples were withdrawn by a registered nurse under sterile conditions.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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: September 30, 2017
• Est. primary completion date: July 1, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 50 Years

Eligibility

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)

Related Conditions & MeSH terms

• Eating Behavior

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
American University of Beirut Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Food acceptability	Food acceptability on a 9 point hedonic scale	Through study completion, an average of 1 year
Primary	Ghrelin	Ghrelin levels measured with Enzyme-linked immunosorbent assay (ELISA) kit	Through study completion, an average of 1 year
Primary	GLP-1	GLP-1 levels measured with Enzyme-linked immunosorbent assay (ELISA) kit	Through study completion, an average of 1 year
Primary	Insulin	Insulin levels measured with Enzyme-linked immunosorbent assay (ELISA) kit	Through study completion, an average of 1 year
Primary	Glucose	Glucose levels measured using VITROS ECiQ Immunodiagnostic System	Through study completion, an average of 1 year
Secondary	Appetite	Appetite score on the visual analogue scale	Through study completion, an average of 1 year
Secondary	Energy intake at the next meal	Measuring quantity of cheese pizza consumed	Through study completion, an average of 1 year