Effect of Previous Diet

Study Overview
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Brief Summary
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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.

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

Conditions
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Healthy

Intervention / Treatment
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* Other: High-fat diet
* Other: High-residue diet


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: High-fat diet<br> | Other: High-fat diet<br>* The high-fat diet (51% fat, 27% carbohydrates, 21% proteins and 4.7 g fiber) will be administered for two weeks..<br>|
| Active Comparator: High-residue diet<br> | Other: High-residue diet<br>* The high-residue diet (19% fat, 62% carbohydrates, 16% proteins and 54.2 g fiber) will be administered for two weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in digestive well-being induced by comfort meal | 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. | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in fullness sensation induced by comfort meal | 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. | 1 day | 
| Change in mood induced by comfort meal | 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. | 1 day | 
| Change in hunger/satiety induced by comfort meal | 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. | 1 day | 
| Intestinal gas evacuation in response to a flatulogenic meal. | Volume of intestinal gas evacuation per anus measured during 4 hours after ingestion of a flatulogenic meal during high-fat versus high-residue diet. | 1 day | 
| Intestinal gas production | 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. | 2 days | 
| Sensation of flatulence | 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. | 2 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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meal ingestion, diet, postprandial responses, hedonic sensations, homeostatic sensations, intestinal gas production