Effect of Previous Diet

Not Applicable

Completed

• Conditions: Healthy
• Interventions: Other: High-residue diet; Other: High-fat diet

• Registration Number: NCT03783221
• Lead Sponsor: Hospital Universitari Vall d'Hebron Research Institute

Brief Summary

Meal ingestion induces digestive responses associated to homeostatic and hedonic sensations. The responses to meal ingestion are modulated by conditioning factors. Single-centre, cross-over, random, open label study comparing the effect of a high-fat/low-residue diet versus low-fat/high residue diet on the responses to meal ingestion. In 20 healthy subjects each diet will be administered during 2 weeks in random order; each diet will be preceded by 2 weeks washout, balanced diet. The aim of the study is to compare the effects of each diet on the responses to comfort and flatulogenic meals, intestinal gas production and digestive sensations.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-10-22
• Status Verified: 2018-12
• Study First Submitted: 2018-12-19
• Study First Submitted QC: 2018-12-19
• Study First Posted: 2018-12-20
• Primary Completion: 2019-03-29
• Study Completion: 2019-04-26
• Last Update Submitted: 2019-05-02
• Last Update Posted: 2019-05-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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-residue diet	High-residue diet	-
High-fat diet	High-fat diet	-

Primary Outcome Measures

Name	Time	Method
Change in digestive well-being induced by comfort meal	1 day	Change in digestive well-being measured by a 10 cm scale graded from -5 (extremely unpleasant sensation) to +5 (extremely pleasant sensation) in response to comfort meal during high-fat versus high-residue diet by repeated measures ANCOVA.

Secondary Outcome Measures

Name	Time	Method
Change in fullness sensation induced by comfort meal	1 day	Change in fullness sensation measured by a 10 cm scale graded from 0 (not at all) to 10 (very much) in response to comfort meal during high-fat versus high-residue diet by repeated measures ANCOVA.
Change in hunger/satiety induced by comfort meal	1 day	Change in hunger/satiety measured by a 10 cm scale graded from -5 (extremely hungry) to +5 (completely satiated) in response to comfort meal during high-fat versus high-residue diet by repeated measures ANCOVA.
Change in mood induced by comfort meal	1 day	Change in mood measured by a 10 cm scale graded from -5 (negative) to +5 (positive) in response to comfort meal during high-fat versus high-residue diet by repeated measures ANCOVA.
Intestinal gas evacuation in response to a flatulogenic meal.	1 day	Volume of intestinal gas evacuation per anus measured during 4 hours after ingestion of a flatulogenic meal during high-fat versus high-residue diet.
Intestinal gas production	2 days	Number of daytime anal gas evacuations measured by an event marker. Participants will be instructed to carry the event marker during daytime and to register every passage of gas per anus for the last two days during high-fat versus high-residue diet.
Sensation of flatulence	2 days	Sensation of flatulence measured by a 10 cm scale graded from 0 (not at all) to 10 (very much) for the last two days during high-fat versus high-residue diet.

Trial Locations

Locations (1)

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