SportsNCT04282265
The Effects of Red Spinach Extract on Physical Performance Following Chronic Resistance Training in Trained Males
A study testing Red Spinach Extract (RSE) in people with Sports, run by Lipscomb University at 1 site in United States.
Trial summary
Red Spinach is a natural food which is a rich source of nitrates, which are beneficial in hemodynamics, cardiovascular function, and have natural hypotensive and antianginal effects . In recent research, Red spinach extract has been shown to be beneficial in acute exercise performance. Read more about this study
- Who is it for?
- Ages 18 to 34 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Sports
- What is being tested?
- Red Spinach Extract (RSE)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Aug 2019to 29 Nov 2019
- 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 18 to 34 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 18-35 years old
- At least 1 year of resistance training experience
- Are free of musculoskeletal injuries
- Are not taking medications that may interfere with study measurements
Who cannot join
- Participant that cannot take either the RSE or placebo supplement will be excluded, as this will be a double-blind study.
- Furthermore, participants that cannot participate in pre- and post-research testing, and/or those that cannot commit to regular training sessions will be excluded.
- Inability to perform physical exercise (determined by health and activity questionnaire)
- Taking any other nutritional supplement or performance enhancing drug.
- Any chronic illness that causes continuous medical care.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Red Spinach Extract on Health on Physical Performance Following Chronic Resistance Training in Trained Males
Red Spinach is a natural food which is a rich source of nitrates, which are beneficial in hemodynamics, cardiovascular function, and have natural hypotensive and antianginal effects . In recent research, Red spinach extract has been shown to be beneficial in acute exercise performance. However, currently it is unclear how these acute increases in performance may translate to long term training adaptations.
This research study is designed to measure the effects of red spinach extract (RSE) on markers of physical performance, body composition, and health following chronic resistance training and anaerobic exercise.
Read the detailed description
The investigators aim to measure muscle strength, athletic performance, body composition, and muscle size in two groups of adults before and after 11 weeks of intervention in a randomized, double blinded study. One group (n=15 ) will receive an intervention of resistance exercise and a Red Spinach Extract supplement, and the other group (n=15) will receive resistance exercise and a placebo (maltodextrin).
- Conditions
- Sports
- Being tested
- Placebo, Red Spinach Extract (RSE)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDietary supplement
Oral placebo capsules will be taken consisting of maltodrextrin daily for 11 weeks
Red Spinach Extract (RSE)Dietary supplement
Oral capsules containing 2g of Red Spinach Extract will be consumed daily for 11 weeks
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Dietary Supplement: Placebo |
| Red Spinach Extract | Experimental | Not described Receives: Dietary Supplement: Red Spinach Extract (RSE) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscular Strength
Muscular strength will be assessed via bench press 1-repetition maximum
Measured: 11 weeks
Muscular Hypertrophy
Muscle thickness of the Rectus femoris and vastus lateralis will be assessed via ultrasonography. Thickeness will be reported in cm.
Measured: 11 weeks
Body Composition
Lean Body Mass, Fat Mass, and Bone Mineral Content will be assessed via Dual X-ray absorptiometry (DXA)
Measured: 11 weeks
Wingate Anaerobic (WnT) Cycle test performance
A 30-second WnT test will be used to assess Average power, peak power, and fatiuge index
Measured: 11 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2020
- Study start23 Aug 2019
- Primary completion29 Nov 2019
- Study completion29 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SportsStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lipscomb University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeremy Townsend, Lipscomb University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04282265
- Sponsor's protocol ID
- 050719
- Status last verified
- Feb 2020
- First submitted
- 16 Jan 2020
- Last updated
- 24 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Red Spinach Extract on Health on Physical Performance Following Chronic Resistance Training in Trained Males
- ClinicalTrials.gov ID
- NCT04282265
- Acronym / sponsor ID
- 050719
- Conditions
- Sports
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Lipscomb UniversityUniversity, hospital or other
- Study start
- 23 Aug 2019 (actual)
- Primary completion
- 29 Nov 2019 (actual)
- Study completion
- 29 Nov 2019 (actual)
- First posted
- 24 Feb 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.
Red Spinach is a natural food which is a rich source of nitrates, which are beneficial in hemodynamics, cardiovascular function, and have natural hypotensive and antianginal effects . In recent research, Red spinach extract has been shown to be beneficial in acute exercise performance. However, currently it is unclear how these acute increases in performance may translate to long term training adaptations.
This research study is designed to measure the effects of red spinach extract (RSE) on markers of physical performance, body composition, and health following chronic resistance training and anaerobic exercise.
Detailed description
The investigators aim to measure muscle strength, athletic performance, body composition, and muscle size in two groups of adults before and after 11 weeks of intervention in a randomized, double blinded study. One group (n=15 ) will receive an intervention of resistance exercise and a Red Spinach Extract supplement, and the other group (n=15) will receive resistance exercise and a placebo (maltodextrin).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: Placebo |
| Red Spinach Extract | Experimental | Dietary Supplement: Red Spinach Extract (RSE) |
Who may qualify
- Ages
- 18 to 34 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 18-35 years old
- At least 1 year of resistance training experience
- Are free of musculoskeletal injuries
- Are not taking medications that may interfere with study measurements
Key exclusion criteria (5 listed)
- Participant that cannot take either the RSE or placebo supplement will be excluded, as this will be a double-blind study.
- Furthermore, participants that cannot participate in pre- and post-research testing, and/or those that cannot commit to regular training sessions will be excluded.
- Inability to perform physical exercise (determined by health and activity questionnaire)
- Taking any other nutritional supplement or performance enhancing drug.
- Any chronic illness that causes continuous medical care.
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 |
|---|---|---|
| PlaceboOral placebo capsules will be taken consisting of maltodrextrin daily for 11 weeks | Dietary supplement | Placebo |
| Red Spinach Extract (RSE)Oral capsules containing 2g of Red Spinach Extract will be consumed daily for 11 weeks | Dietary supplement | Red Spinach Extract |
Primary outcome
Muscular Strength
Time frame: 11 weeks
Muscular strength will be assessed via bench press 1-repetition maximum
Muscular Hypertrophy
Time frame: 11 weeks
Muscle thickness of the Rectus femoris and vastus lateralis will be assessed via ultrasonography. Thickeness will be reported in cm.
Body Composition
Time frame: 11 weeks
Lean Body Mass, Fat Mass, and Bone Mineral Content will be assessed via Dual X-ray absorptiometry (DXA)
Wingate Anaerobic (WnT) Cycle test performance
Time frame: 11 weeks
A 30-second WnT test will be used to assess Average power, peak power, and fatiuge index
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 24 Feb 2020.
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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 Red Spinach Extract (RSE) in people with Sports, run by Lipscomb University at 1 site in United States.
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 5 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 24 Feb 2020. 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 United States. 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?
Muscular Strength (time frame: 11 weeks). The study lists 4 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 24 Feb 2020.