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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03779321
Enrollment
30
Registered
2018-12-19
Start date
2016-09-01
Completion date
2017-09-30
Last updated
2018-12-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Eating Behavior

Keywords

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

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 At each test day, fasting blood samples were withdrawn by a registered nurse under sterile conditions.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

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 At each test day, fasting blood samples were withdrawn by a registered nurse under sterile conditions.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

OTHERAcceptability

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

Sponsors

American University of Beirut Medical Center
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
MALE
Age
18 Years to 50 Years
Healthy volunteers
Yes

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)

Design outcomes

Primary

MeasureTime frameDescription
GhrelinThrough study completion, an average of 1 yearGhrelin levels measured with Enzyme-linked immunosorbent assay (ELISA) kit
InsulinThrough study completion, an average of 1 yearInsulin levels measured with Enzyme-linked immunosorbent assay (ELISA) kit
GlucoseThrough study completion, an average of 1 yearGlucose levels measured using VITROS ECiQ Immunodiagnostic System
Food acceptabilityThrough study completion, an average of 1 yearFood acceptability on a 9 point hedonic scale
GLP-1Through study completion, an average of 1 yearGLP-1 levels measured with Enzyme-linked immunosorbent assay (ELISA) kit

Secondary

MeasureTime frameDescription
Energy intake at the next mealThrough study completion, an average of 1 yearMeasuring quantity of cheese pizza consumed
AppetiteThrough study completion, an average of 1 yearAppetite score on the visual analogue scale

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026