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Completed

NCT Number: NCT03783221

Effect of Previous Diet

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.

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Key information

Conditions

Healthy

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Vall d'Hebron

Barcelona, 08035, Spain

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

high-fat diet

Other

The high-fat diet (51% fat, 27% carbohydrates, 21% proteins and 4.7 g fiber) will be administered for two weeks..

High-residue diet

Other

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

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Hospital Universitari Vall d'Hebron Research Institute

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Dec 20, 2018
Registry last updated
May 6, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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