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

Body Composition Clinical Trial

— LEUCI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04345237
• Other study ID #: UCAMCFE-00013
• Status: Completed
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Body Composition
• Elderly Person
• Physical Exercise

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.