Effect of Meal Composition on the Responses to Meal Ingestion

April 24, 2017 updated by: Hospital Universitari Vall d'Hebron Research Institute

Factors That Determine the Responses to Meal Ingestion: Meal Composition

Aim: to determine to what extent meal composition influences postprandial sensations independently of palatability. The postprandial responses to a low-fat (240 Kcal) versus a high-fat (275 Kcal) test meal (150 g humus) with the same physical and organoleptic characteristics (taste, smell, colour, texture, consistency, temperature) will be studied on a cross-over design. The responses to the meals will be tested on 2 different days. Participants (12 non-obese healthy men) will be instructed to eat a standard dinner the day before, to consume a standard breakfast at home after overnight fast, and to report to the laboratory, where the test meal will be administered 3 h after breakfast. Studies will be conducted in a quiet, isolated room with participants sitting on a chair. Perception will be measured at 5 min intervals 10 min before and 20 min after ingestion and at 10 min intervals up to 60 min after the probe meal.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Barcelona, Spain, 08035
        • University Hospital Vall d'Hebron

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: High-fat meal
Other: High-fat meal
High-fat meal
ACTIVE_COMPARATOR: Low-fat meal
Other: Low-fat meal
Low-fat meal with the same physical and organoleptic characteristics as the high-calorie meal.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in digestive well-being measured after the test meal
Time Frame: 1 day
Change in average well-being measured by 10 score scales at the end of the test meal.
1 day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in satiety measured after the test meal
Time Frame: 1 day
Change in average satiety measured by 10 score scales at the end of the test meal
1 day
Change in fullness sensation measured after the test meal
Time Frame: 1 day
Change in average fullness measured by 10 score scales at the end of the test meal
1 day
Change in abdominal discomfort/pain sensation measured after the test meal
Time Frame: 1 day
Change in average abdominal discomfort/pain measured by 10 score scales at the end of the test meal
1 day
Change in mood measured after the test meal
Time Frame: 1 day
Change in average mood measured by 10 score scales at the end of the test meal.
1 day

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Meal palatability
Time Frame: 1 day
Meal palatability measured by 10 score scales at the end of the test meal.
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Universitari Vall d'Hebron Research Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 16, 2017

Primary Completion (ACTUAL)

March 17, 2017

Study Completion (ACTUAL)

March 21, 2017

Study Registration Dates

First Submitted

March 14, 2017

First Submitted That Met QC Criteria

March 17, 2017

First Posted (ACTUAL)

March 20, 2017

Study Record Updates

Last Update Posted (ACTUAL)

April 25, 2017

Last Update Submitted That Met QC Criteria

April 24, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • PR(AG)338/2016B

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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