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

Not Applicable

Completed

• Conditions: Sarcopenia; Physical Exercise
• Interventions: Dietary Supplement: Dietary supplement consumption and physical exercise

• Registration Number: NCT04612127
• Lead Sponsor: Universidad Católica San Antonio de Murcia

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.

Study Timeline

• Study Start: 2020-09-14
• Status Verified: 2020-10
• Study First Submitted: 2020-10-15
• Study First Submitted QC: 2020-10-27
• Study First Posted: 2020-11-02
• Primary Completion: 2021-06-08
• Study Completion: 2021-07-31
• Last Update Submitted: 2021-08-17
• Last Update Posted: 2021-08-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental group - Spinach	Dietary supplement consumption and physical exercise	Consumption for 90 days of spinach extract (1000mg) Four capsules will be consumed per day, two with breakfast and two with lunch.
control group Placebo (sucrose)	Dietary supplement consumption and physical exercise	Four capsules will be consumed per day, two with breakfast and two with lunch.

Primary Outcome Measures

Name	Time	Method
Muscle function	From baseline to 90 days	Isometric dynamometry

Secondary Outcome Measures

Name	Time	Method
Muscle mass	From baseline to 90 days	Bioimpedance, in grams.
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
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.
Balance	From baseline to 90 days	Force platform Kistler
Nutritional survey	From baseline to 90 days	24 hour memory

Trial Locations

Locations (1)

Catholic University of Murcia; 🇪🇸 Murcia, Spain