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

Universidad Católica San Antonio de Murcia

Status: Completed

Conditions: Physical Exercise; Sarcopenia

Treatments: Dietary Supplement: Dietary supplement consumption and physical exercise

Study type: Interventional

Funder types: Other

Identifiers

NCT04612127

UCAMCFE-00016

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 patients

Sex: All

Ages: 50 to 75 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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50 participants in 2 patient groups, including a placebo group

Experimental group - Spinach

Experimental group

Description:

Consumption for 90 days of spinach extract (1000mg) Four capsules will be consumed per day, two with breakfast and two with lunch.

Treatment:

Dietary Supplement: Dietary supplement consumption and physical exercise

control group Placebo (sucrose)

Placebo Comparator group

Description:

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

Treatment:

Dietary Supplement: Dietary supplement consumption and physical exercise