The Effect of Food Hedonics on Appetite Hormones Levels

Eating Behavior Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02615613
• Other study ID #: NUT.AO.11
• Status: Completed
• Phase: N/A
• First received: November 25, 2015
• Last updated: November 26, 2015
• Start date: January 2014
• Est. completion date: June 2015

Study information

• Verified date: November 2015
• Source: American University of Beirut Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Lebanon: Institutional Review Board (AUB)
• Study type: Interventional

Clinical Trial Summary

30-40 healthy male subjects with a BMI between 18.5 and 24.9 kg/m2 will be tested for food preferences using a questionnaire with 141 different foods. Accordingly, a high acceptability/palatability food will be selected (average score of ≥ 7 on the 9-point hedonic scale). Two versions of the selected high palatability food will be devised by modifying it to yield the original high and the modified low acceptability versions. The two versions will differ only in palatability and will be equicaloric. Subjects who agree on the acceptability of the two versions of the food (11 subjects) will consume, at fasting, the two versions of the food in a cross over design over two sessions. Each session will include an acceptability test, using the 9-point hedonic scale, on three instances: after sampling a spoonful, eating the whole portion and after 240 min. The quantity consumed on each session will constitute 30% of the subject's resting energy expenditure. Moreover, fasting and postprandial hunger ratings and blood samples will be collected at time 0 and after 15, 30, 60, 120, 180 and 240 min of the food/meal's ingestion. The visual analogue scale will be used for huger ratings.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• 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

• Stable body weight for at least three months before the study with absence of any form of dieting, food restriction or other abnormal eating behaviors (to minimize effect of weight change on ghrelin status)

Exclusion Criteria:

• Smoking

• Substance abuse such as alcohol or drugs

• Medical or psychological illness

• Use of medications

• Previous gastrointestinal surgery

• History of weight fluctuation (weight loss of greater than 5% within the past 3 months)

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Eating Behavior

Intervention

Other:
• Low Acceptability Meal

• High acceptability meal

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 score		Two weeks	No
Primary	Ghrelin level		Two weeks	No
Secondary	Glucose level		Two weeks	No
Secondary	Appetite score on the visual analogue scale		Two weeks	No
Secondary	Insulin level		2 weeks	No