Nutritional Clinical Trial to Evaluate the Efficacy of Daily Consumption for 12 Weeks of a Spinach Extract on Muscle Function in Subjects Over 50 Years of Age
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Sarcopenia
- Sponsor
- Universidad Católica San Antonio de Murcia
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Muscle function
- Status
- Completed
- Last Updated
- 4 years ago
Overview
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.
Investigators
Francisco Javier López Román
Principal Investigator
Universidad Católica San Antonio de Murcia
Eligibility Criteria
Inclusion Criteria
- •Age between 50 and 75 years.
- •Body mass index less than
- •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
- •Pregnant or lactating women.
- •Inability to understand informed consent.
Outcomes
Primary Outcomes
Muscle function
Time Frame: From baseline to 90 days
Isometric dynamometry
Secondary Outcomes
- Muscle mass(From baseline to 90 days)
- Health Questionnaire(From baseline to 90 days)
- 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.)
- Balance(From baseline to 90 days)
- Nutritional survey(From baseline to 90 days)