NCT Number: NCT02615613
The Effect of Food Hedonics on Appetite Hormones Levels
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.
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Notify MeKey information
Conditions
Age range
18 year–50 year
Sex eligibility
Male
Study type
Interventional
Phase
Not applicable
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
- 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)
Treatment and study plan
High acceptability meal
OtherPrimary outcomes
-
Food acceptability score
Time frame: Two weeks
-
Ghrelin level
Time frame: Two weeks
Secondary outcomes
-
Glucose level
Time frame: Two weeks
-
Appetite score on the visual analogue scale
Time frame: Two weeks
-
Insulin level
Time frame: 2 weeks
Sponsors and collaborators
Lead sponsor
American University of Beirut Medical Center
Other
Registry information
Official study title
Effect of Food Acceptability on Appetite Hormones' Response in Normal Weight Male Subjects
Important dates
- Study start
- 2014
- Primary completion
- 2015
- Study completion
- 2015
- First posted
- Nov 26, 2015
- Registry last updated
- Nov 30, 2015
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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