- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04292106
The Effects of Red Spinach Extract Supplementation on Isometric Strength, Resistance Exercise and Cognitive Performance
January 13, 2022 updated by: Jeremy Townsend, Lipscomb University
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
11
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Tennessee
-
Nashville, Tennessee, United States, 37215
- Jeremy Townsend
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 34 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Placebo Comparator: Placebo
|
Oral placebo capsules will be taken consisting of maltodrextrin daily for 7 days
|
|
Experimental: Red Spinach Extract (RSE)
|
Oral capsules containing 2g of Red Spinach Extract will be consumed daily for 7 days
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
Through study completion, during both treatments (~4 weeks)
|
|
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.
|
Through study completion, during both treatments (~4 weeks)
|
|
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.
|
Through study completion, during both treatments (~4 weeks)
|
|
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.
|
Through study completion, during both treatments (~4 weeks)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Estimated Muscle Blood Flow via Near-infrared Spectroscopy (NIRS)
Time Frame: Through study completion, during both treatments (~4 weeks)
|
Measures of muscle oxygenation of the anterior deltoid will be estimated using a NIRS Device.
|
Through study completion, during both treatments (~4 weeks)
|
|
Cognitive Performance via Stroop Test
Time Frame: Through study completion, during both treatments (~4 weeks)
|
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
|
Through study completion, during both treatments (~4 weeks)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Jeremy Townsend, PhD, Lipscomb University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 26, 2019
Primary Completion (Actual)
March 30, 2020
Study Completion (Actual)
March 30, 2020
Study Registration Dates
First Submitted
January 17, 2020
First Submitted That Met QC Criteria
February 28, 2020
First Posted (Actual)
March 2, 2020
Study Record Updates
Last Update Posted (Actual)
January 14, 2022
Last Update Submitted That Met QC Criteria
January 13, 2022
Last Verified
January 1, 2022
More Information
Terms related to this study
Other Study ID Numbers
- 092619
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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