Factors That Determine the Responses to Meal Ingestion: Effect of Previous Diet
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Change in digestive well-being induced by comfort meal
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
High-fat diet
Intervention: High-fat diet (Other)
High-residue diet
Intervention: High-residue diet (Other)
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)