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Effect of Previous Diet

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ClinicalTrials.gov Identifier: NCT03783221
Recruitment Status : Completed
First Posted : December 20, 2018
Last Update Posted : May 6, 2019
Sponsor:
Information provided by (Responsible Party):
Hospital Universitari Vall d'Hebron Research Institute

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 Not Applicable

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Study Type : Interventional  (Clinical Trial)
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 : October 22, 2018
Actual Primary Completion Date : March 29, 2019
Actual Study Completion Date : April 26, 2019

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.




Primary Outcome Measures :
  1. Change in digestive well-being induced by comfort meal [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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. [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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.



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03783221


Locations
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Spain
University Hospital Vall d'Hebron
Barcelona, Spain, 08035
Sponsors and Collaborators
Hospital Universitari Vall d'Hebron Research Institute

Publications of Results:
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Responsible Party: Hospital Universitari Vall d'Hebron Research Institute
ClinicalTrials.gov Identifier: NCT03783221     History of Changes
Other Study ID Numbers: PR(AG)338/2016J
First Posted: December 20, 2018    Key Record Dates
Last Update Posted: May 6, 2019
Last Verified: December 2018

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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