Effect of Previous Diet

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03783221
• Other study ID #: PR(AG)338/2016J
• Status: Completed
• Phase: N/A
• Start date: October 22, 2018
• Est. completion date: April 26, 2019

Study information

• Verified date: December 2018
• Source: Hospital Universitari Vall d'Hebron Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: April 26, 2019
• Est. primary completion date: March 29, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

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..
• High-residue diet
The high-residue diet (19% fat, 62% carbohydrates, 16% proteins and 54.2 g fiber) will be administered for two weeks.

Locations

Country	Name	City	State
Spain	University Hospital Vall d'Hebron	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Universitari Vall d'Hebron Research Institute

Country where clinical trial is conducted

Spain, 

References & 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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