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OpenTrials
Completed

NCT Number: NCT04612127

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

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.

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Key information

Age range

50 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Catholic University of Murcia

Murcia, 30107, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Universidad Católica San Antonio de Murcia

Other

Registry information

Official study 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

Acronym: SPISAR

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Nov 2, 2020
Registry last updated
Aug 18, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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