Effect of Previous Diet
Factors That Determine the Responses to Meal Ingestion: Effect of Previous Diet
1 other identifier
interventional
20
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable healthy
Started Oct 2018
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 22, 2018
CompletedFirst Submitted
Initial submission to the registry
December 19, 2018
CompletedFirst Posted
Study publicly available on registry
December 20, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 29, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
April 26, 2019
CompletedMay 6, 2019
December 1, 2018
5 months
December 19, 2018
May 2, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (6)
Change in fullness sensation induced by comfort meal
1 day
Change in mood induced by comfort meal
1 day
Change in hunger/satiety induced by comfort meal
1 day
Intestinal gas evacuation in response to a flatulogenic meal.
1 day
Intestinal gas production
2 days
- +1 more secondary outcomes
Study Arms (2)
High-fat diet
EXPERIMENTALHigh-residue diet
ACTIVE COMPARATORInterventions
The high-fat diet (51% fat, 27% carbohydrates, 21% proteins and 4.7 g fiber) will be administered for two weeks..
The high-residue diet (19% fat, 62% carbohydrates, 16% proteins and 54.2 g fiber) will be administered for two weeks.
Eligibility Criteria
You may qualify if:
- non-obese
You may not qualify if:
- history of gastrointestinal symptoms
- prior obesity
- use of medications
- history of anosmia and ageusia
- current dieting
- alcohol abuse
- psychological disorders
- eating disorders
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Hospital Vall d'Hebron
Barcelona, 08035, Spain
Related Publications (1)
Pribic T, Azpiroz F. Biogastronomy: Factors that determine the biological response to meal ingestion. Neurogastroenterol Motil. 2018 Jul;30(7):e13309. doi: 10.1111/nmo.13309. Epub 2018 Feb 2.
PMID: 29392797RESULT
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 19, 2018
First Posted
December 20, 2018
Study Start
October 22, 2018
Primary Completion
March 29, 2019
Study Completion
April 26, 2019
Last Updated
May 6, 2019
Record last verified: 2018-12