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

NCT ID: NCT04612127

Last Updated: 2021-08-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-14
• Study Completion Date: 2021-07-31

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.

Conditions

Sarcopenia; Physical Exercise

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Experimental group - Spinach

Consumption for 90 days of spinach extract (1000mg)

Four capsules will be consumed per day, two with breakfast and two with lunch.

Group Type: EXPERIMENTAL

Dietary supplement consumption and physical exercise

Intervention Type: 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.

control group Placebo (sucrose)

Four capsules will be consumed per day, two with breakfast and two with lunch.

Group Type: PLACEBO_COMPARATOR

Dietary supplement consumption and physical exercise

Intervention Type: 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.

Interventions

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.

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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.

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Universidad Católica San Antonio de Murcia

OTHER

Sponsor Role: lead

Responsible Party

Francisco Javier López Román

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Catholic University of Murcia

Murcia, , Spain

Countries

Spain

Other Identifiers

UCAMCFE-00016

Identifier Type: -

Identifier Source: org_study_id