SarcopeniaSPISARNCT04612127
Efficacy of the Consumption of a Spinach Extract on Muscle Function in Subjects Over 50 Years of Age
A study testing Dietary supplement consumption and physical exercise in people with Sarcopenia and Physical Exercise, run by Universidad Católica San Antonio de Murcia at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Sarcopenia, Physical Exercise
- What is being tested?
- Dietary supplement consumption and physical exercise
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteSpain
- Study dates
- 14 Sep 2020to 31 Jul 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- Serious or terminal illnesses.
- Subjects with a body mass index above 32.
- Pregnant or lactating women.
- Inability to understand informed consent.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Sarcopenia, Physical Exercise
- Being tested
- Dietary supplement consumption and physical exercise
- Medical subject headings
- Sarcopenia, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary supplement consumption and physical exerciseDietary 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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group - Spinach | Experimental | Consumption for 90 days of spinach extract (1000mg)
Four capsules will be consumed per day, two with breakfast and two with lunch. Receives: Dietary Supplement: Dietary supplement consumption and physical exercise |
| control group Placebo (sucrose) | Placebo comparator | Four capsules will be consumed per day, two with breakfast and two with lunch. Receives: Dietary Supplement: Dietary supplement consumption and physical exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle function
Isokinetic dynamometry. Knee flexion and extension force
Measured: From baseline to 90 days
Muscle function
Isometric dynamometry
Measured: From baseline to 90 days
Secondary outcomes (6)
Muscle mass
Dual X-ray absorptiometry (DEXA), measured in grams.
Measured: From baseline to 90 days
Muscle mass
Bioimpedance, in grams.
Measured: From baseline to 90 days
Balance
Force platform Kistler
Measured: From baseline to 90 days
Health Questionnaire
Questionnaire Quality of life SF-36. It consists of 36 questions that assess the health and well-being of the person
Measured: From baseline to 90 days
Nutritional survey
24 hour memory
Measured: From baseline to 90 days
Liver safety variables
It is a blood test blood, with the aim of determining if there is any alteration in the liver.
Measured: It is measured on an empty stomach, before and after the consumption time (60 days) with the experimental product and the placebo product.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2020
- Study start14 Sep 2020
- Primary completion8 Jun 2021
- Study completion31 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SarcopeniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Católica San Antonio de Murcia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Francisco Javier López Román, Universidad Católica San Antonio de Murcia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04612127
- Sponsor's protocol ID
- UCAMCFE-00016
- Acronym
- SPISAR
- Status last verified
- Oct 2020
- First submitted
- 15 Oct 2020
- Last updated
- 18 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04612127
- Acronym / sponsor ID
- SPISAR / UCAMCFE-00016
- Conditions
- Sarcopenia, Physical Exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Universidad Católica San Antonio de MurciaUniversity, hospital or other
- Study start
- 14 Sep 2020 (actual)
- Primary completion
- 8 Jun 2021 (actual)
- Study completion
- 31 Jul 2021 (actual)
- First posted
- 2 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group - Spinach | Experimental | Dietary Supplement: Dietary supplement consumption and physical exerciseConsumption for 90 days of spinach extract (1000mg) Four capsules will be consumed per day, two with breakfast and two with lunch. |
| control group Placebo (sucrose) | Placebo comparator | Dietary Supplement: Dietary supplement consumption and physical exerciseFour capsules will be consumed per day, two with breakfast and two with lunch. |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dietary supplement consumption and physical exerciseThe 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. | Dietary supplement | Experimental group - Spinach, control group Placebo (sucrose) |
Primary outcome
Muscle function
Time frame: From baseline to 90 days
Isokinetic dynamometry. Knee flexion and extension force
Muscle function
Time frame: From baseline to 90 days
Isometric dynamometry
6 secondary outcomes
Muscle mass
Time frame: From baseline to 90 days
Muscle mass
Time frame: From baseline to 90 days
Balance
Time frame: From baseline to 90 days
Health Questionnaire
Time frame: From baseline to 90 days
Nutritional survey
Time frame: From baseline to 90 days
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dietary supplement consumption and physical exercise in people with Sarcopenia and Physical Exercise, run by Universidad Católica San Antonio de Murcia at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Muscle function (time frame: From baseline to 90 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2021.