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Completed

NCT Number: NCT04345237

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

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.

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Key information

Conditions

Elderly Person Behavior Body Composition Motor Activity Physical Exercise

Age range

55 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Catholic University of Murcia

Murcia, 30107, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Primary outcomes

  1. Muscle mass

    Time frame: Change of this measurement at 3 months.

    Dual X-ray absorptiometry (DEXA)

  2. Total fat mass

    Time frame: Change of this measurement at 3 months.

    Dual X-ray absorptiometry (DEXA)

  3. Total fat free mass

    Time frame: Change of this measurement at 3 months.

    Dual X-ray absorptiometry (DEXA)

  4. Fat free mass on upper limb

    Time frame: Change of this measurement at 3 months.

    Dual X-ray absorptiometry (DEXA)

  5. Upper limb fat mass

    Time frame: Change of this measurement at 3 months.

    Dual X-ray absorptiometry (DEXA)

  6. Fat-free mass in the lower limb

    Time frame: Change of this measurement at 3 months.

    Dual X-ray absorptiometry (DEXA)

  7. Lower limb fat mass

    Time frame: Change of this measurement at 3 months.

    Dual X-ray absorptiometry (DEXA)

Secondary outcomes

  1. Elbow extension

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

    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.

  2. Elbow flexion

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

    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.

  3. Knee extension

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

    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.

  4. Knee flexion

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

    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.

  5. Blood samples: Glycid metabolism and lipid metabolism.

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

    Basic glucemia, total cholesterol, cholesterol HDL, cholesterol LDL, , triglycerides.

  6. Liver safety variables

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

    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.

Sponsors and collaborators

Lead sponsor

Universidad Católica San Antonio de Murcia

Other

Registry information

Official study title

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

Acronym: LEUCI

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Apr 14, 2020
Registry last updated
May 21, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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