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

Universidad Católica San Antonio de Murcia

Status: Completed

Conditions: Elderly Person; Physical Exercise; Body Composition

Treatments: Dietary Supplement: dietary supplement consumption

Study type: Interventional

Funder types: Other

Identifiers

NCT04345237

UCAMCFE-00013

Details and patient eligibility

About

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.

Full 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.

Enrollment: 142 patients

Sex: All

Ages: 55 to 70 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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142 participants in 6 patient groups

Experimental group 1 (TS + placebo)

Experimental group

Description:

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.

Treatment:

Dietary Supplement: dietary supplement consumption

Experimental group 2 (TS + leucine)

Experimental group

Description:

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.

Treatment:

Dietary Supplement: dietary supplement consumption

Experimental group 3 (HRC + placebo)

Experimental group

Description:

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.

Treatment:

Dietary Supplement: dietary supplement consumption

Experimental group 4 (HRC + leucine)

Experimental group

Description:

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.

Treatment:

Dietary Supplement: dietary supplement consumption

Experimental group 5 (no physical exercise + leucine)

Experimental group

Description:

The subjects will not carry out any type of physical activity. Daily consumption for 3 months of milk enriched with leucine.

Treatment:

Dietary Supplement: dietary supplement consumption

Control (no physical exercise + placebo)

No Intervention group

Description:

The subjects will not carry out any type of physical activity. Daily consumption for 3 months of placebo milk.