Efficacy of the Consumption of a Spinach Extract on Muscle Function in Subjects Over 50 Years of Age

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Sarcopenia, Physical Exercise

Intervention / Treatment
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* Dietary Supplement: Dietary supplement consumption and physical exercise


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental group - Spinach<br>Consumption for 90 days of spinach extract (1000mg) Four capsules will be consumed per day, two with breakfast and two with lunch. | Dietary Supplement: Dietary supplement consumption and physical exercise<br>* 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.<br>|
| Placebo Comparator: control group Placebo (sucrose)<br>Four capsules will be consumed per day, two with breakfast and two with lunch. | Dietary Supplement: Dietary supplement consumption and physical exercise<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Muscle function | Isokinetic dynamometry. Knee flexion and extension force | From baseline to 90 days | 
| Muscle function | Isometric dynamometry | From baseline to 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Muscle mass | Dual X-ray absorptiometry (DEXA), measured in grams. | From baseline to 90 days | 
| Muscle mass | Bioimpedance, in grams. | From baseline to 90 days | 
| Balance | Force platform Kistler | From baseline to 90 days | 
| Health Questionnaire | Questionnaire Quality of life SF-36. It consists of 36 questions that assess the health and well-being of the person | From baseline to 90 days | 
| Nutritional survey | 24 hour memory | From baseline to 90 days | 
| Liver safety variables | It is a blood test blood, with the aim of determining if there is any alteration in the liver. | It is measured on an empty stomach, before and after the consumption time (60 days) with the experimental product and the placebo product. |