Factors That Determine the Responses to Food Ingestion: Protein Load

NCT ID: NCT06139237

Last Updated: 2023-11-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-30

Study Completion Date

2024-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants

Study Groups

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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).

Group Type EXPERIMENTAL

High-protein supplement

Intervention Type OTHER

High protein supplement 200 mL

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)

Group Type ACTIVE_COMPARATOR

Balanced supplement

Intervention Type OTHER

Balanced supplement 200 mL

Interventions

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High-protein supplement

High protein supplement 200 mL

Intervention Type OTHER

Balanced supplement

Balanced supplement 200 mL

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Hospital Universitari Vall d'Hebron Research Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University Hospital Vall d'Hebron

Barcelona, , Spain

Site Status

Countries

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Spain

Central Contacts

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Fernando Azpiroz, MD

Role: CONTACT

+34932746259

Gloria Santaliestra

Role: CONTACT

Facility Contacts

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Fernando Azpiroz, MD

Role: primary

+34932746259

Gloria Santaliestra

Role: backup

Other Identifiers

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PR(AG)338/2016P

Identifier Type: -

Identifier Source: org_study_id

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