Effect of Meal Composition on the Responses to Meal Ingestion
Factors That Determine the Responses to Meal Ingestion: Meal Composition
1 other identifier
interventional
12
1 country
1
Brief Summary
Aim: to determine to what extent meal composition influences postprandial sensations independently of palatability. The postprandial responses to a low-fat (240 Kcal) versus a high-fat (275 Kcal) test meal (150 g humus) with the same physical and organoleptic characteristics (taste, smell, colour, texture, consistency, temperature) will be studied on a cross-over design. The responses to the meals will be tested on 2 different days. Participants (12 non-obese healthy men) will be instructed to eat a standard dinner the day before, to consume a standard breakfast at home after overnight fast, and to report to the laboratory, where the test meal will be administered 3 h after breakfast. Studies will be conducted in a quiet, isolated room with participants sitting on a chair. Perception will be measured at 5 min intervals 10 min before and 20 min after ingestion and at 10 min intervals up to 60 min after the probe meal.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable healthy
Started Jan 2017
Shorter than P25 for not_applicable healthy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 16, 2017
CompletedFirst Submitted
Initial submission to the registry
March 14, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 17, 2017
CompletedFirst Posted
Study publicly available on registry
March 20, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
March 21, 2017
CompletedApril 25, 2017
March 1, 2017
2 months
March 14, 2017
April 24, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in digestive well-being measured after the test meal
Change in average well-being measured by 10 score scales at the end of the test meal.
1 day
Secondary Outcomes (4)
Change in satiety measured after the test meal
1 day
Change in fullness sensation measured after the test meal
1 day
Change in abdominal discomfort/pain sensation measured after the test meal
1 day
Change in mood measured after the test meal
1 day
Other Outcomes (1)
Meal palatability
1 day
Study Arms (2)
High-fat meal
EXPERIMENTALLow-fat meal
ACTIVE COMPARATORInterventions
Low-fat meal with the same physical and organoleptic characteristics as the high-calorie meal.
Eligibility Criteria
You may qualify if:
- non-obese
You may not qualify if:
- history of gastrointestinal symptoms
- prior obesity
- use of medications
- history of anosmia and ageusia
- current dieting
- alcohol abuse
- psychological disorders
- eating disorders
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Hospital Vall d'Hebron
Barcelona, 08035, Spain
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- OTHER
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 14, 2017
First Posted
March 20, 2017
Study Start
January 16, 2017
Primary Completion
March 17, 2017
Study Completion
March 21, 2017
Last Updated
April 25, 2017
Record last verified: 2017-03