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

Sarcopenia Clinical Trial

— SPISAR  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04612127
• Other study ID #: UCAMCFE-00016
• Status: Completed
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Physical Exercise
• Sarcopenia

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.