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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04612127
Other study ID # UCAMCFE-00016
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 14, 2020
Est. completion date July 31, 2021

Study information

Verified date October 2020
Source Universidad Católica San Antonio de Murcia
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 50
Est. completion date July 31, 2021
Est. primary completion date June 8, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 50 Years to 75 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Dietary 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.

Locations

Country Name City State
Spain Catholic University of Murcia Murcia

Sponsors (1)

Lead Sponsor Collaborator
Universidad Católica San Antonio de Murcia

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary Muscle function Isokinetic dynamometry. Knee flexion and extension force From baseline to 90 days
Primary Muscle function Isometric dynamometry From baseline to 90 days
Secondary Muscle mass Dual X-ray absorptiometry (DEXA), measured in grams. From baseline to 90 days
Secondary Muscle mass Bioimpedance, in grams. From baseline to 90 days
Secondary Balance Force platform Kistler From baseline to 90 days
Secondary 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
Secondary Nutritional survey 24 hour memory From baseline to 90 days
Secondary 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.
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