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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental group - Spinach | Experimental | Consumption for 90 days of spinach extract (1000mg) Four capsules will be consumed per day, two with breakfast and two with lunch. |
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| control group Placebo (sucrose) | Placebo Comparator | Four capsules will be consumed per day, two with breakfast and two with lunch. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dietary supplement consumption and physical exercise | Dietary Supplement | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Catholic University of Murcia | Murcia | 30107 | Spain |
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| ID | Term |
|---|---|
| D055948 | Sarcopenia |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D009133 | Muscular Atrophy |
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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| 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. |
| D001284 | Atrophy |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |
| D001519 | Behavior |