Healthy
Conditions
Keywords
meal ingestion, diet, postprandial responses, hedonic sensations, homeostatic sensations, intestinal gas production
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.
Interventions
OTHERHigh-fat diet
The high-fat diet (51% fat, 27% carbohydrates, 21% proteins and 4.7 g fiber) will be administered for two weeks..
OTHERHigh-residue diet
The high-residue diet (19% fat, 62% carbohydrates, 16% proteins and 54.2 g fiber) will be administered for two weeks.
Sponsors
Hospital Universitari Vall d'Hebron Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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 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. |
| 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. |
| 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. |
Countries
Spain
Outcome results
None listed