The Effect of Food Hedonics on Appetite Hormones Levels
Effect of Food Acceptability on Appetite Hormones' Response in Normal Weight Male Subjects
1 other identifier
interventional
11
0 countries
N/A
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jan 2014
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2015
CompletedFirst Submitted
Initial submission to the registry
November 25, 2015
CompletedFirst Posted
Study publicly available on registry
November 26, 2015
CompletedNovember 30, 2015
November 1, 2015
1.4 years
November 25, 2015
November 26, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Food acceptability score
Two weeks
Ghrelin level
Two weeks
Secondary Outcomes (3)
Glucose level
Two weeks
Appetite score on the visual analogue scale
Two weeks
Insulin level
2 weeks
Study Arms (2)
High acceptability meal
EXPERIMENTALA custard recipe was used as the high acceptability meal
Low acceptability meal
EXPERIMENTALThe regular custard recipe was reformulated to yield a low acceptability version
Interventions
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
November 25, 2015
First Posted
November 26, 2015
Study Start
January 1, 2014
Primary Completion
June 1, 2015
Study Completion
June 1, 2015
Last Updated
November 30, 2015
Record last verified: 2015-11