Factors That Determine the Responses to Food Ingestion: Protein Load

November 14, 2023 updated by: Hospital Universitari Vall d'Hebron Research Institute

Factores Que Determinan la Respuesta a la Ingesta: Efecto de la Carga Proteica

Aim: to determine to what extent meal composition influences postprandial sensations. Experimental design: randomized cross-ower study comparing the responses to a high protein (47.3% protein, 39.4% carbohydrates, 13.3% lipids) versus a balanced (22.2% protein, 67.85% carbohydrates, 9.95% lipids). In each participant the meals (both containing 20.8 g protein and diluted to a volume of 200 mL) will be tested on separate days. Healthy, non-obese participants (8 men and 8 women) 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, at 10 min intervals up to 60 min after the meal and at 30 min up to 120 min after ingestion. Blood samples for biochemical and hormonal determinations will be taken before and after ingestion.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

16

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 Contact

Study Contact Backup

Study Locations

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

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 Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: High-protein supplement
The high-protein supplements contains 47.3% protein, 39.4% carbohydrates, 13.3% lipids. A dose containing 20.8 g protein and diluted to a volume of 200 mL will be administered (187 Kcal).
Other: High-protein supplement
High protein supplement 200 mL
Active Comparator: Balanced supplement
The high-protein supplements 22.2% protein, 67.85% carbohydrates, 9.95% lipids. A dose containing 20.8 g protein and diluted to a volume of 200 mL will be administered (399.3 Kcal)
Other: Balanced supplement
Balanced supplement 200 mL

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

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 (Estimated)

November 1, 2023

Primary Completion (Estimated)

January 1, 2024

Study Completion (Estimated)

March 1, 2024

Study Registration Dates

First Submitted

November 14, 2023

First Submitted That Met QC Criteria

November 14, 2023

First Posted (Estimated)

November 20, 2023

Study Record Updates

Last Update Posted (Estimated)

November 20, 2023

Last Update Submitted That Met QC Criteria

November 14, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • PR(AG)338/2016P

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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