Body Composition, Elderly Person, Physical Exercise
Conditions
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.
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.
Interventions
DIETARY_SUPPLEMENTdietary 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
Sponsors
Universidad Católica San Antonio de Murcia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
55 Years to 70 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Lower limb fat mass | Change of this measurement at 3 months. | Dual X-ray absorptiometry (DEXA) |
| Muscle mass | Change of this measurement at 3 months. | Dual X-ray absorptiometry (DEXA) |
| Total fat mass | Change of this measurement at 3 months. | Dual X-ray absorptiometry (DEXA) |
| Total fat free mass | Change of this measurement at 3 months. | Dual X-ray absorptiometry (DEXA) |
| Fat free mass on upper limb | Change of this measurement at 3 months. | Dual X-ray absorptiometry (DEXA) |
| Upper limb fat mass | Change of this measurement at 3 months. | Dual X-ray absorptiometry (DEXA) |
| Fat-free mass in the lower limb | Change of this measurement at 3 months. | Dual X-ray absorptiometry (DEXA) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Elbow flexion | 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. |
| Knee extension | 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. |
| Knee flexion | 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. |
| 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. | Basic glucemia, total cholesterol, cholesterol HDL, cholesterol LDL, , triglycerides. |
| Liver safety variables | 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. |
| Elbow extension | 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. |
Countries
Spain
Outcome results
None listed