Physical Exercise, Sarcopenia
Conditions
Brief summary
Controlled, randomized, single-center, double-blind clinical trial, with two parallel branches depending on the product consumed, to measure the efficacy of a supplement extracted from spinach on muscle strength in subjects over 50 years of age.
Detailed description
Subjects who meet the selection criteria will make two visits to the laboratory to perform the tests established in the protocol. In addition, all subjects will develop a program of strength, polyarticular, individualized and progressive exercises in which the main muscle groups are worked. The program will be held three days a week (36 sessions). Subsequently, a statistical analysis will be performed with the variables measured in the study to obtain results.
Interventions
DIETARY_SUPPLEMENTDietary supplement consumption and physical exercise
The consumption time of the experimental product was 90 days and the control consumption time was 90 days. During this time, training should be done three times a week.
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
50 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
* Age between 50 and 75 years. * Body mass index less than 32. * Subjects who do not develop physical exercise scheduled on a weekly basis. * 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 or supplement that modifies body composition. * Presence of absolute or relative contraindications dictated by the American College of Sports Medicine, for the performance of physical exercise. * Presence of chronic diseases that prevent the performance of a physical exercise program (disabling arthropathies, moderate / severe chronic lung disease, 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. * Serious or terminal illnesses. * Subjects with a body mass index above 32. * Pregnant or lactating women. * Inability to understand informed consent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Muscle function | From baseline to 90 days | Isokinetic dynamometry. Knee flexion and extension force |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Muscle mass | From baseline to 90 days | Dual X-ray absorptiometry (DEXA), measured in grams. |
| Balance | From baseline to 90 days | Force platform Kistler |
| Health Questionnaire | From baseline to 90 days | Questionnaire Quality of life SF-36. It consists of 36 questions that assess the health and well-being of the person |
| Nutritional survey | From baseline to 90 days | 24 hour memory |
| Liver safety variables | It is measured on an empty stomach, before and after the consumption time (60 days) with the experimental product and the placebo product. | It is a blood test blood, with the aim of determining if there is any alteration in the liver. |
Countries
Spain
Outcome results
None listed