Effect of Meal Composition on the Responses to Meal Ingestion

Not Applicable

Completed

• Conditions: Healthy
• Interventions: Other: High-fat meal; Other: Low-fat meal

• Registration Number: NCT03084276
• Lead Sponsor: Hospital Universitari Vall d'Hebron Research Institute

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-01-16
• Status Verified: 2017-03
• Study First Submitted: 2017-03-14
• Primary Completion: 2017-03-17
• Study First Submitted QC: 2017-03-17
• Study First Posted: 2017-03-20
• Study Completion: 2017-03-21
• Last Update Submitted: 2017-04-24
• Last Update Posted: 2017-04-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 12

Inclusion Criteria

• non-obese

Exclusion Criteria

• history of gastrointestinal symptoms
• prior obesity
• use of medications
• history of anosmia and ageusia
• current dieting
• alcohol abuse
• psychological disorders
• eating disorders

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
High-fat meal	High-fat meal	-
Low-fat meal	Low-fat meal	-

Primary Outcome Measures

Name	Time	Method
Change in digestive well-being measured after the test meal	1 day	Change in average well-being measured by 10 score scales at the end of the test meal.

Secondary Outcome Measures

Name	Time	Method
Change in satiety measured after the test meal	1 day	Change in average satiety measured by 10 score scales at the end of the test meal
Change in mood measured after the test meal	1 day	Change in average mood measured by 10 score scales at the end of the test meal.
Change in fullness sensation measured after the test meal	1 day	Change in average fullness measured by 10 score scales at the end of the test meal
Change in abdominal discomfort/pain sensation measured after the test meal	1 day	Change in average abdominal discomfort/pain measured by 10 score scales at the end of the test meal

Trial Locations

Locations (1)

University Hospital Vall d'Hebron; 🇪🇸 Barcelona, Spain