Back to resultsEfficacy of the Consumption of a Spinach Extract on Muscle Function in Subjects Over 50 Years of Age (SPISAR)
Primary Purpose
Sarcopenia, Physical Exercise
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Dietary supplement consumption and physical exercise
Sponsored by
About this trial
This is an interventional treatment trial for Sarcopenia
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.
Sites / Locations
- Catholic University of Murcia
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Experimental group - Spinach
control group Placebo (sucrose)
Arm Description
Consumption for 90 days of spinach extract (1000mg) Four capsules will be consumed per day, two with breakfast and two with lunch.
Four capsules will be consumed per day, two with breakfast and two with lunch.
Outcomes
Primary Outcome Measures
Muscle function
Isokinetic dynamometry. Knee flexion and extension force
Muscle function
Isometric dynamometry
Secondary Outcome Measures
Muscle mass
Dual X-ray absorptiometry (DEXA), measured in grams.
Muscle mass
Bioimpedance, in grams.
Balance
Force platform Kistler
Health Questionnaire
Questionnaire Quality of life SF-36. It consists of 36 questions that assess the health and well-being of the person
Nutritional survey
24 hour memory
Liver safety variables
It is a blood test blood, with the aim of determining if there is any alteration in the liver.
Full Information
NCT ID
NCT04612127
First Posted
October 15, 2020
Last Updated
August 17, 2021
Sponsor
Universidad Católica San Antonio de Murcia
1. Study Identification
Unique Protocol Identification Number
NCT04612127
Brief Title
Efficacy of the Consumption of a Spinach Extract on Muscle Function in Subjects Over 50 Years of Age
Acronym
SPISAR
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
2. Study Status
Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
September 14, 2020 (Actual)
Primary Completion Date
June 8, 2021 (Actual)
Study Completion Date
July 31, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad Católica San Antonio de Murcia
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sarcopenia, Physical Exercise
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Experimental group - Spinach
Arm Type
Experimental
Arm Description
Consumption for 90 days of spinach extract (1000mg)
Four capsules will be consumed per day, two with breakfast and two with lunch.
Arm Title
control group Placebo (sucrose)
Arm Type
Placebo Comparator
Arm Description
Four capsules will be consumed per day, two with breakfast and two with lunch.
Intervention Type
Dietary Supplement
Intervention Name(s)
Dietary supplement consumption and physical exercise
Intervention Description
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 Measure Information:
Title
Muscle function
Description
Isokinetic dynamometry. Knee flexion and extension force
Time Frame
From baseline to 90 days
Title
Muscle function
Description
Isometric dynamometry
Time Frame
From baseline to 90 days
Secondary Outcome Measure Information:
Title
Muscle mass
Description
Dual X-ray absorptiometry (DEXA), measured in grams.
Time Frame
From baseline to 90 days
Title
Muscle mass
Description
Bioimpedance, in grams.
Time Frame
From baseline to 90 days
Title
Balance
Description
Force platform Kistler
Time Frame
From baseline to 90 days
Title
Health Questionnaire
Description
Questionnaire Quality of life SF-36. It consists of 36 questions that assess the health and well-being of the person
Time Frame
From baseline to 90 days
Title
Nutritional survey
Description
24 hour memory
Time Frame
From baseline to 90 days
Title
Liver safety variables
Description
It is a blood test blood, with the aim of determining if there is any alteration in the liver.
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Facility Information:
Facility Name
Catholic University of Murcia
City
Murcia
ZIP/Postal Code
30107
Country
Spain
12. IPD Sharing Statement
Learn more about this trial
Efficacy of the Consumption of a Spinach Extract on Muscle Function in Subjects Over 50 Years of Age
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