Effect of Previous Diet

• Sponsor: Hospital Universitari Vall d'Hebron Research Institute (Other)
• Overall Status: Completed
• CT.gov ID: NCT03783221
• Collaborator: (none)
• Enrollment: 20
• Location: 1
• Arms: 2
• Actual Duration (Months): 6.1
• Patients Per Site Per Month: 3.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Other: High-fat diet; Other: High-residue diet	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 20 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: Factors That Determine the Responses to Meal Ingestion: Effect of Previous Diet
• Actual Study Start Date: Oct 22, 2018
• Actual Primary Completion Date: Mar 29, 2019
• Actual Study Completion Date: Apr 26, 2019

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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

1. 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.

2. 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.

3. 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.

4. 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.

5. 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.

6. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Hospital Vall d'Hebron	Barcelona		Spain	08035

Sponsors and Collaborators

• Hospital Universitari Vall d'Hebron Research Institute

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Hospital Universitari Vall d'Hebron Research Institute
• ClinicalTrials.gov Identifier: NCT03783221
• Other Study ID Numbers: PR(AG)338/2016J
• First Posted: Dec 20, 2018
• Last Update Posted: May 6, 2019
• Last Verified: Dec 1, 2018

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Hospital Universitari Vall d'Hebron Research Institute: meal ingestion; diet; postprandial responses; hedonic sensations; homeostatic sensations; intestinal gas production

Study Results

No Results Posted as of May 6, 2019