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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04612127
Recruitment Status : Completed
First Posted : November 2, 2020
Last Update Posted : August 18, 2021
Sponsor:
Information provided by (Responsible Party):
Francisco Javier López Román, Universidad Católica San Antonio de Murcia

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.

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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

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.





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.



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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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04612127


Locations
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Spain
Catholic University of Murcia
Murcia, Spain, 30107
Sponsors and Collaborators
Universidad Católica San Antonio de Murcia
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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    Key Record Dates
Last Update Posted: August 18, 2021
Last Verified: October 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Sarcopenia
Muscular Atrophy
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Atrophy
Pathological Conditions, Anatomical