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Clinical Trials/NCT03783221
NCT03783221
Completed
Not Applicable

Factors That Determine the Responses to Meal Ingestion: Effect of Previous Diet

Hospital Universitari Vall d'Hebron Research Institute1 site in 1 country20 target enrollmentOctober 22, 2018
ConditionsHealthy

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Healthy
Sponsor
Hospital Universitari Vall d'Hebron Research Institute
Enrollment
20
Locations
1
Primary Endpoint
Change in digestive well-being induced by comfort meal
Status
Completed
Last Updated
6 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 22, 2018
End Date
April 26, 2019
Last Updated
6 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Eligibility Criteria

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

Outcomes

Primary Outcomes

Change in digestive well-being induced by comfort meal

Time Frame: 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 Outcomes

  • Change in fullness sensation induced by comfort meal(1 day)
  • Change in hunger/satiety induced by comfort meal(1 day)
  • Change in mood induced by comfort meal(1 day)
  • Intestinal gas evacuation in response to a flatulogenic meal.(1 day)
  • Intestinal gas production(2 days)
  • Sensation of flatulence(2 days)

Study Sites (1)

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