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

Randomized Clinical Trial on Changes in Body Composition When Ingesting a Dairy Compound Enriched With Leucine Daily for 3 Months

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.

Study Overview

• Status: Completed
• Conditions: Body Composition; Physical Exercise; Elderly Person
• Intervention / Treatment: Dietary supplement: dietary supplement consumption

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.

• Study Type: Interventional
• Enrollment (Actual): 142
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Murcia, Spain, 30107
    • Catholic University of Murcia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Dietary supplement: 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
Experimental: 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.	Dietary supplement: 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
Experimental: 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.	Dietary supplement: 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
Experimental: 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.	Dietary supplement: 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
Experimental: 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.	Dietary supplement: 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
No Intervention: Control (no physical exercise + placebo); The subjects will not carry out any type of physical activity. Daily consumption for 3 months of placebo milk.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Elbow extension	Upper limb isokinetic dynamometry. The angular velocities used were 60 ° · s-1 and 270 ° · s-1. The variables measured for each of them were maximum isokinetic torque, maximum isokinetic torque in relation to body weight, total work and average power.	This measurement is carried out in each of the groups, at the beginning (baseline) and at 3 months (end).
Elbow flexion	Upper limb isokinetic dynamometry. The angular velocities used were 60 ° · s-1 and 270 ° · s-1. The variables measured for each of them were maximum isokinetic torque, maximum isokinetic torque in relation to body weight, total work and average power.	This measurement is carried out in each of the groups, at the beginning (baseline) and at 3 months (end).
Knee extension	Lower limb isokinetic dynamometry. The angular velocities used were 60 ° · s-1 and 270 ° · s-1. The variables measured for each of them were maximum isokinetic torque, maximum isokinetic torque in relation to body weight, total work and average power.	This measurement is carried out in each of the groups, at the beginning (baseline) and at 3 months (end).
Knee flexion	Lower limb isokinetic dynamometry. The angular velocities used were 60 ° · s-1 and 270 ° · s-1. The variables measured for each of them were maximum isokinetic torque, maximum isokinetic torque in relation to body weight, total work and average power.	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.	Basic glucemia, total cholesterol, cholesterol HDL, cholesterol LDL, , triglycerides.	Blood samples will be taken twice, once at baseline, at the beginning of the trial and once at the end after 3 months.
Liver safety variables	It is a blood test that measures the presence of some enzymes, proteins and bilirubin in the blood, with the aim of determining if there is any alteration in the liver.	Blood samples will be taken twice, once at baseline, at the beginning of the trial and once at the end after 3 months.

Collaborators and Investigators

• Sponsor: Universidad Católica San Antonio de Murcia

Study record dates

Study Major Dates

• Study Start (Actual): November 15, 2019
• Primary Completion (Actual): February 15, 2020
• Study Completion (Actual): April 30, 2020

Study Registration Dates

• First Submitted: April 8, 2020
• First Submitted That Met QC Criteria: April 11, 2020
• First Posted (Actual): April 14, 2020

Study Record Updates

• Last Update Posted (Actual): May 21, 2020
• Last Update Submitted That Met QC Criteria: May 20, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: UCAMCFE-00013

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No