SportsNCT04292106
The Effects of Red Spinach Extract Supplementation on Isometric Strength, Resistance Exercise and Cognitive Performance
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. Red spinach extract has been shown to be beneficial in exercise performance, albeit mostly in aerobic exercise. 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
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Sep 2019to 30 Mar 2020
- 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
- 18-34 years old Participants must have at least 1 year of resistance training experience.
- Free of any physical limitations, medications, and supplements that may affect performance, as determined by a health and activity questionnaire.
- Are free of musculoskeletal injuries
- Are not taking medications that may interfere with study measurements
Who cannot join
- Participants 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 Supplementation on Isometric Strength, Resistance Exercise and Cognitive Performance.
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. Red spinach extract has been shown to be beneficial in exercise performance, albeit mostly in aerobic exercise. In a previous study in our lab, we found that dietary nitrate consumption resulted in significantly greater isometric force production in teenage males. However, currently there is little know regarding the effects of dietary nitrate supplementation on isometric strength, resistance exercise and cognitive performance.
Read the detailed description
This research study is designed to measure the effects of red spinach extract (RSE) on markers of physical and cognitive performance during and following anaerobic exercise.
- Conditions
- Sports
- Being tested
- Red Spinach Extract (RSE), Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Red Spinach Extract (RSE)Dietary supplement
Oral capsules containing 2g of Red Spinach Extract will be consumed daily for 7 days
PlaceboDietary supplement
Oral placebo capsules will be taken consisting of maltodrextrin daily for 7 days
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Dietary Supplement: Placebo |
| Red Spinach Extract (RSE) | 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.
Bench Press Repetitions to Fatiuge
Number of repetitions completed in each set during the acute exercise bout will be recorded and analyzed
Measured: Through study completion, during both treatments (~4 weeks)
Bench Press Power
Power during bench press repetitions will be measured via a linear transducer.
Measured: Through study completion, during both treatments (~4 weeks)
Isometric Mid-thigh pull (IMTP) Peak Force
Peak Force will be measured via dual force plates during a full-body isometric strength test.
Measured: Through study completion, during both treatments (~4 weeks)
Isometric Mid-thigh pull (IMTP) Rate of Force Development
Rate of Force development will be measured via dual force plates during a full-body isometric strength test.
Measured: Through study completion, during both treatments (~4 weeks)
Secondary outcomes (2)
Estimated Muscle Blood Flow via Near-infrared Spectroscopy (NIRS)
Measures of muscle oxygenation of the anterior deltoid will be estimated using a NIRS Device.
Measured: Through study completion, during both treatments (~4 weeks)
Cognitive Performance via Stroop Test
The Stroop Color and Word Test (SCWT) is a neuropsychological test used to assess cognitive performance. This will be administered before and after the fatiguing bench press protocol
Measured: Through study completion, during both treatments (~4 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2020
- Study start26 Sep 2019
- Primary completion30 Mar 2020
- Study completion30 Mar 2020
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
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lipscomb University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeremy Townsend, Lipscomb University
- Investigators
- Jeremy Townsend, PhD, Principal investigator, Lipscomb University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04292106
- Sponsor's protocol ID
- 092619
- Status last verified
- Jan 2022
- First submitted
- 17 Jan 2020
- Last updated
- 14 Jan 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Red Spinach Extract Supplementation on Isometric Strength, Resistance Exercise and Cognitive Performance.
- ClinicalTrials.gov ID
- NCT04292106
- Acronym / sponsor ID
- 092619
- Conditions
- Sports
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Lipscomb UniversityUniversity, hospital or other
- Study start
- 26 Sep 2019 (actual)
- Primary completion
- 30 Mar 2020 (actual)
- Study completion
- 30 Mar 2020 (actual)
- First posted
- 2 Mar 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. Red spinach extract has been shown to be beneficial in exercise performance, albeit mostly in aerobic exercise. In a previous study in our lab, we found that dietary nitrate consumption resulted in significantly greater isometric force production in teenage males. However, currently there is little know regarding the effects of dietary nitrate supplementation on isometric strength, resistance exercise and cognitive performance.
Detailed description
This research study is designed to measure the effects of red spinach extract (RSE) on markers of physical and cognitive performance during and following anaerobic exercise.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: Placebo |
| Red Spinach Extract (RSE) | 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)
- 18-34 years old Participants must have at least 1 year of resistance training experience.
- Free of any physical limitations, medications, and supplements that may affect performance, as determined by a health and activity questionnaire.
- Are free of musculoskeletal injuries
- Are not taking medications that may interfere with study measurements
Key exclusion criteria (5 listed)
- Participants 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 |
|---|---|---|
| Red Spinach Extract (RSE)Oral capsules containing 2g of Red Spinach Extract will be consumed daily for 7 days | Dietary supplement | Red Spinach Extract (RSE) |
| PlaceboOral placebo capsules will be taken consisting of maltodrextrin daily for 7 days | Dietary supplement | Placebo |
Primary outcome
Bench Press Repetitions to Fatiuge
Time frame: Through study completion, during both treatments (~4 weeks)
Number of repetitions completed in each set during the acute exercise bout will be recorded and analyzed
Bench Press Power
Time frame: Through study completion, during both treatments (~4 weeks)
Power during bench press repetitions will be measured via a linear transducer.
Isometric Mid-thigh pull (IMTP) Peak Force
Time frame: Through study completion, during both treatments (~4 weeks)
Peak Force will be measured via dual force plates during a full-body isometric strength test.
Isometric Mid-thigh pull (IMTP) Rate of Force Development
Time frame: Through study completion, during both treatments (~4 weeks)
Rate of Force development will be measured via dual force plates during a full-body isometric strength test.
2 secondary outcomes
Estimated Muscle Blood Flow via Near-infrared Spectroscopy (NIRS)
Time frame: Through study completion, during both treatments (~4 weeks)
Cognitive Performance via Stroop Test
Time frame: Through study completion, during both treatments (~4 weeks)
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 14 Jan 2022.
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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.
Jeremy Townsend, PhD principal investigator
Lipscomb University
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 14 Jan 2022. 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?
Bench Press Repetitions to Fatiuge (time frame: Through study completion, during both treatments (~4 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 14 Jan 2022.