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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
11

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • United States
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Placebo
Dietary supplement: Placebo
Oral placebo capsules will be taken consisting of maltodrextrin daily for 7 days
Experimental: Red Spinach Extract (RSE)
Dietary supplement: 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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Lipscomb University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 26, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 30, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 30, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 17, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 28, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 2, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 14, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 13, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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