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

NCT04612127 | Completed DMC

• 1 other identifier: UCAMCFE-00016
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Sarcopenia; Physical Exercise

Outcome Measures

Primary Outcomes (2)

• Muscle function

  Isokinetic dynamometry. Knee flexion and extension force

  From baseline to 90 days

• Muscle function

  Isometric dynamometry

  From baseline to 90 days

Secondary Outcomes (6)

• Muscle mass

  From baseline to 90 days

• Muscle mass

  From baseline to 90 days

• Balance

  From baseline to 90 days

• Health Questionnaire

  From baseline to 90 days

• Nutritional survey

  From baseline to 90 days

Study Arms (2)

Experimental group - Spinach

EXPERIMENTAL

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

control group Placebo (sucrose)

PLACEBO COMPARATOR

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

Dietary Supplement: Dietary supplement consumption and physical exercise

Interventions

Dietary supplement consumption and physical exercise 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.

Experimental group - Spinach; control group Placebo (sucrose)

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad Católica San Antonio de Murcia: lead

Study Sites (1)

Catholic University of Murcia

Murcia, 30107, Spain

Location

MeSH Terms

Conditions

Sarcopenia; Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 15, 2020
• First Posted: November 2, 2020
• Study Start: September 14, 2020
• Primary Completion: June 8, 2021
• Study Completion: July 31, 2021
• Last Updated: August 18, 2021

Record last verified: 2020-10

Locations

ES (1)