Changes in Body Composition When Ingesting a Dairy Compound Enriched With Leucine

NCT ID: NCT04345237

Last Updated: 2020-05-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 142 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-11-15
• Study Completion Date: 2020-04-30

Brief Summary

Controlled clinical trial, randomized by strata (sex and period of the study), with 6 parallel branches to the study depending on the type of product consumed and the type of physical exercise program performed, double-blind masked for the consumption of the product and single-center.

Detailed Description

The subjects that meet the selection criteria will make a total of seven visits to the research laboratory (two of them to collect product) and will carry out the pre-established tests in the protocol. Subsequently, a statistical analysis will be carried out with the variables measured in the study to obtain results.

Conditions

Elderly Person; Body Composition; Physical Exercise

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Experimental group 1 (TS + placebo)

Training twice a week, with wave periodization. Traditional training (TS) in two circuits. Each exercise is separated by a rest period of 3 minutes and 5 minutes between circuits.

Daily consumption for 3 months of placebo milk.

Group Type: EXPERIMENTAL

dietary supplement consumption

Intervention Type: DIETARY_SUPPLEMENT

Consumption of the product under study for 3 months, milk placebo or experimental product (leucine milk).

In addition, 5 of the arms perform physical activity training

Experimental group 2 (TS + leucine)

Training twice a week, with wave periodization. Traditional training (TS) in two circuits. Each exercise is separated by a rest period of 3 minutes and 5 minutes between circuits.

Daily consumption for 3 months of milk enriched with leucine.

Group Type: EXPERIMENTAL

dietary supplement consumption

Intervention Type: DIETARY_SUPPLEMENT

Consumption of the product under study for 3 months, milk placebo or experimental product (leucine milk).

In addition, 5 of the arms perform physical activity training

Experimental group 3 (HRC + placebo)

Training twice a week, with wave periodization. High intensity training (HRC) on two circuits. Each exercise is separated by a rest period of 35 seconds and 5 minutes between circuits.

Daily consumption for 3 months of placebo milk.

Group Type: EXPERIMENTAL

dietary supplement consumption

Intervention Type: DIETARY_SUPPLEMENT

Consumption of the product under study for 3 months, milk placebo or experimental product (leucine milk).

In addition, 5 of the arms perform physical activity training

Experimental group 4 (HRC + leucine)

Training twice a week, with wave periodization. High intensity training (HRC) on two circuits. Each exercise is separated by a rest period of 35 seconds and 5 minutes between circuits.

Daily consumption for 3 months of milk enriched with leucine.

Group Type: EXPERIMENTAL

dietary supplement consumption

Intervention Type: DIETARY_SUPPLEMENT

Consumption of the product under study for 3 months, milk placebo or experimental product (leucine milk).

In addition, 5 of the arms perform physical activity training

Experimental group 5 (no physical exercise + leucine)

The subjects will not carry out any type of physical activity.

Daily consumption for 3 months of milk enriched with leucine.

Group Type: EXPERIMENTAL

dietary supplement consumption

Intervention Type: DIETARY_SUPPLEMENT

Consumption of the product under study for 3 months, milk placebo or experimental product (leucine milk).

In addition, 5 of the arms perform physical activity training

Control (no physical exercise + placebo)

The subjects will not carry out any type of physical activity.

Daily consumption for 3 months of placebo milk.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

dietary supplement consumption

Consumption of the product under study for 3 months, milk placebo or experimental product (leucine milk).

In addition, 5 of the arms perform physical activity training

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

• Subjects of both sexes with age between 55-70 years.
• Body mass index less than 35.
• Subjects who have given written informed consent to participate in the study.

Exclusion Criteria

• Consumption during the 6 months prior to the study of functional food enriched with leucine or nutritional supplement based on protein concentrate or that presents in its chemical composition leucine.
• Presence of absolute or relative contraindications ruled by the American College of Sports Medicine (ACSM, 1995), during the performance of stress tests.
• Presence of chronic diseases that prevent the performance of a physical exercise program or an exercise test (disabling arthropathies, moderate / severe chronic lung diseases, ischemic heart disease under treatment, arrhythmias, etc).
• Abuse in the ingestion of alcohol.
• Present hypersensitivity or intolerance to any of the components of the products under study.
• Inability to understand informed consent.

• Minimum Eligible Age: 55 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Universidad Católica San Antonio de Murcia

OTHER

Sponsor Role: lead

Responsible Party

Francisco Javier López Román

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Catholic University of Murcia

Murcia, , Spain

Countries

Spain

Other Identifiers

UCAMCFE-00013

Identifier Type: -

Identifier Source: org_study_id