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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04345237
Other study ID # UCAMCFE-00013
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 15, 2019
Est. completion date April 30, 2020

Study information

Verified date April 2020
Source Universidad Católica San Antonio de Murcia
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 142
Est. completion date April 30, 2020
Est. primary completion date February 15, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 55 Years to 70 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Spain Catholic University of Murcia Murcia

Sponsors (1)

Lead Sponsor Collaborator
Universidad Católica San Antonio de Murcia

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary Muscle mass Dual X-ray absorptiometry (DEXA) Change of this measurement at 3 months.
Primary Total fat mass Dual X-ray absorptiometry (DEXA) Change of this measurement at 3 months.
Primary Total fat free mass Dual X-ray absorptiometry (DEXA) Change of this measurement at 3 months.
Primary Fat free mass on upper limb Dual X-ray absorptiometry (DEXA) Change of this measurement at 3 months.
Primary Upper limb fat mass Dual X-ray absorptiometry (DEXA) Change of this measurement at 3 months.
Primary Fat-free mass in the lower limb Dual X-ray absorptiometry (DEXA) Change of this measurement at 3 months.
Primary Lower limb fat mass Dual X-ray absorptiometry (DEXA) Change of this measurement at 3 months.
Secondary 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).
Secondary 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).
Secondary 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).
Secondary 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).
Secondary 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.
Secondary 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.
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