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

• Sponsor: Universidad Católica San Antonio de Murcia (Other)
• Overall Status: Completed
• CT.gov ID: NCT04612127
• Collaborator: (none)
• Enrollment: 50
• Location: 1
• Arms: 2
• Actual Duration (Months): 10.5
• Patients Per Site Per Month: 4.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Sarcopenia; Physical Exercise	Dietary Supplement: Dietary supplement consumption and physical exercise	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 50 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Sep 14, 2020
• Actual Primary Completion Date: Jun 8, 2021
• Actual Study Completion Date: Jul 31, 2021

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Muscle function [From baseline to 90 days]

   Isokinetic dynamometry. Knee flexion and extension force

2. Muscle function [From baseline to 90 days]

   Isometric dynamometry

Secondary Outcome Measures

1. Muscle mass [From baseline to 90 days]

   Dual X-ray absorptiometry (DEXA), measured in grams.

2. Muscle mass [From baseline to 90 days]

   Bioimpedance, in grams.

3. Balance [From baseline to 90 days]

   Force platform Kistler

4. 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

5. Nutritional survey [From baseline to 90 days]

   24 hour memory

6. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 50 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Catholic University of Murcia	Murcia		Spain	30107

Sponsors and Collaborators

• Universidad Católica San Antonio de Murcia

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Francisco Javier López Román, Principal Investigator, Universidad Católica San Antonio de Murcia
• ClinicalTrials.gov Identifier: NCT04612127
• Other Study ID Numbers: UCAMCFE-00016
• First Posted: Nov 2, 2020
• Last Update Posted: Aug 18, 2021
• Last Verified: Oct 1, 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Sarcopenia

Study Results

No Results Posted as of Aug 18, 2021