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

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

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.

Study Overview

• Status: Completed
• Conditions: Sarcopenia; Physical Exercise
• Intervention / Treatment: Dietary supplement: Dietary supplement consumption and physical exercise

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 Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Murcia, Spain, 30107
    • Catholic University of Murcia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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.
Placebo Comparator: control group Placebo (sucrose); Four capsules will be consumed per day, two with breakfast and two with lunch.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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
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.

Collaborators and Investigators

• Sponsor: Universidad Católica San Antonio de Murcia

Study record dates

Study Major Dates

• Study Start (Actual): September 14, 2020
• Primary Completion (Actual): June 8, 2021
• Study Completion (Actual): July 31, 2021

Study Registration Dates

• First Submitted: October 15, 2020
• First Submitted That Met QC Criteria: October 27, 2020
• First Posted (Actual): November 2, 2020

Study Record Updates

• Last Update Posted (Actual): August 18, 2021
• Last Update Submitted That Met QC Criteria: August 17, 2021
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Neuromuscular Manifestations; Pathological Conditions, Anatomical; Muscular Atrophy; Atrophy; Sarcopenia
• Other Study ID Numbers: UCAMCFE-00016

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No