Clinical trial NCT04612127: Efficacy of the Consumption of a Spinach Extract on Muscle Function in Subjects Over 50 Years of Age
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sarcopenia
Physical Exercise
Lead sponsor: Universidad Católica San Antonio de Murcia
Sponsor class: OTHER
First posted: 2020-11-02
Enrollment: 50
Sex: ALL
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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.

Primary outcomes:
measure: Muscle function
timeFrame: From baseline to 90 days
measure: Muscle function
timeFrame: From baseline to 90 days
Secondary outcomes:
measure: Muscle mass
timeFrame: From baseline to 90 days
measure: Muscle mass
timeFrame: From baseline to 90 days
measure: Balance
timeFrame: From baseline to 90 days
measure: Health Questionnaire
timeFrame: From baseline to 90 days
measure: Nutritional survey
timeFrame: From baseline to 90 days
measure: Liver safety variables
timeFrame: It is measured on an empty stomach, before and after the consumption time (60 days) with the experimental product and the placebo product.
Other outcomes:
Locations:
city: Murcia
country: Spain
facility: Catholic University of Murcia
Study officials:
References: