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

NCT04345237 | Completed DMC

• 1 other identifier: UCAMCFE-00013
• Study Type: interventional
• Target: 142
• Locations: 1 country
• Sites: 1

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.

Conditions

Elderly Person; Body Composition; Physical Exercise

Outcome Measures

Primary Outcomes (7)

• Muscle mass

  Dual X-ray absorptiometry (DEXA)

  Change of this measurement at 3 months.

• Total fat mass

  Dual X-ray absorptiometry (DEXA)

  Change of this measurement at 3 months.

• Total fat free mass

  Dual X-ray absorptiometry (DEXA)

  Change of this measurement at 3 months.

• Fat free mass on upper limb

  Dual X-ray absorptiometry (DEXA)

  Change of this measurement at 3 months.

• Upper limb fat mass

  Dual X-ray absorptiometry (DEXA)

  Change of this measurement at 3 months.

• Fat-free mass in the lower limb

  Dual X-ray absorptiometry (DEXA)

  Change of this measurement at 3 months.

• Lower limb fat mass

  Dual X-ray absorptiometry (DEXA)

  Change of this measurement at 3 months.

Secondary Outcomes (6)

• Elbow extension

  This measurement is carried out in each of the groups, at the beginning (baseline) and at 3 months (end).

• Elbow flexion

  This measurement is carried out in each of the groups, at the beginning (baseline) and at 3 months (end).

• Knee extension

  This measurement is carried out in each of the groups, at the beginning (baseline) and at 3 months (end).

• Knee flexion

  This measurement is carried out in each of the groups, at the beginning (baseline) and at 3 months (end).

• Blood samples: Glycid metabolism and lipid metabolism.

  Blood samples will be taken twice, once at baseline, at the beginning of the trial and once at the end after 3 months.

Study Arms (6)

Experimental group 1 (TS + placebo)

EXPERIMENTAL

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.

Dietary Supplement: dietary supplement consumption

Experimental group 2 (TS + leucine)

EXPERIMENTAL

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.

Dietary Supplement: dietary supplement consumption

Experimental group 3 (HRC + placebo)

EXPERIMENTAL

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.

Dietary Supplement: dietary supplement consumption

Experimental group 4 (HRC + leucine)

EXPERIMENTAL

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.

Dietary Supplement: dietary supplement consumption

Experimental group 5 (no physical exercise + leucine)

EXPERIMENTAL

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

Dietary Supplement: dietary supplement consumption

Control (no physical exercise + placebo)

NO INTERVENTION

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

Interventions

dietary supplement consumption 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 1 (TS + placebo); Experimental group 2 (TS + leucine); Experimental group 3 (HRC + placebo); Experimental group 4 (HRC + leucine); Experimental group 5 (no physical exercise + leucine)

Eligibility Criteria

• Age: 55 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad Católica San Antonio de Murcia: lead

Study Sites (1)

Catholic University of Murcia

Murcia, 30107, Spain

Location

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 8, 2020
• First Posted: April 14, 2020
• Study Start: November 15, 2019
• Primary Completion: February 15, 2020
• Study Completion: April 30, 2020
• Last Updated: May 21, 2020

Record last verified: 2020-04

Locations

ES (1)