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

• ClinicalTrials.gov Identifier: NCT04612127
• Recruitment Status: Completed
• First Posted: November 2, 2020
• Last Update Posted: August 18, 2021
• Sponsor: Universidad Católica San Antonio de Murcia
• Information provided by (Responsible Party): Francisco Javier López Román, Universidad Católica San Antonio de Murcia

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	Not Applicable

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 (Clinical Trial)
• 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: September 14, 2020
• Actual Primary Completion Date: June 8, 2021
• Actual Study Completion Date: July 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 [ Time Frame: From baseline to 90 days ]
   Isokinetic dynamometry. Knee flexion and extension force
2. Muscle function [ Time Frame: From baseline to 90 days ]
   Isometric dynamometry

Secondary Outcome Measures :

1. Muscle mass [ Time Frame: From baseline to 90 days ]
   Dual X-ray absorptiometry (DEXA), measured in grams.
2. Muscle mass [ Time Frame: From baseline to 90 days ]
   Bioimpedance, in grams.
3. Balance [ Time Frame: From baseline to 90 days ]
   Force platform Kistler
4. Health Questionnaire [ Time Frame: 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 [ Time Frame: From baseline to 90 days ]
   24 hour memory
6. Liver safety variables [ Time Frame: 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

• Ages Eligible for Study: 50 Years to 75 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

Spain

Catholic University of Murcia

Murcia, Spain, 30107

Sponsors and Collaborators

Universidad Católica San Antonio de Murcia

More Information

• 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: November 2, 2020
• Last Update Posted: August 18, 2021
• Last Verified: October 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Sarcopenia; Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical