Effect of Beet-root Juice and PBM Treatments on Muscle Fatigue

March 19, 2024 updated by: Andrew Wells, Ph.D, Wake Forest University

Application of Beet-root Juice Supplementation and Photobiomodulation Treatment on Forearm Muscle Fatigue in Older Adults

The goal of this randomized counterbalanced repeated measures study is to test beet-root juice supplementation and red light therapy augment forearm muscle endurance in apparently healthy older adults over 65 years of age. The main questions seek to answer the following question:

Does beet-root juice supplementation improve forearm muscle endurance compared to a placebo supplement?

Does red light therapy improve forearm muscle endurance compared to a sham light exposure?

Does beet-root juice supplementation in combination with red light therapy improve forearm muscle endurance compared to a placebo-sham light control?

Study Overview

Study Type

Interventional

Enrollment (Estimated)

10

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 Contact

  • Name: Andrew D Wells, Ph.D.
  • Phone Number: 2156 (336) 758-5837
  • Email: wellsa@wfu.edu

Study Locations

    • North Carolina
      • Winston-Salem, North Carolina, United States, 27106
        • Recruiting
        • Wake Forest Univesity
        • Contact:
          • Andrew D Wells, Ph.D.
          • Phone Number: 2156 336-758-5837
          • Email: wellsa@wfu.edu

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

65 years and older (Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Self-reports performing at least 30 minutes of light to moderate intensity physical activity 3 times per week for the last three months

Exclusion Criteria:

  • Currently smoke
  • Have smoked within the last 6 months
  • Are taking taking supplements known to increase blood nitrate levels
  • Have a known kidney disease
  • Have a known liver disease
  • Have a known thyroid condition
  • Have a known gastritis condition
  • Are taking medications that are known to cause complications with nitrate supplementation
  • Have known or reported joint pain within the dominant hand

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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Beet-root juice plus red-light therapy
Two days prior to the forearm endurance protocol, participants will be provided and instructed to consume a 400mg nitrate once per day. On the day of the forearm endurance protocol, the participants will be provided and instructed to consume a third 400mg dose of nitrates at least 150 minutes before forearm endurance testing.
Other Names:
  • Beet it Sport
Participants will place their dominant forearm 15 centimeters away from the light source and have their dominant forearm exposed to 660nm wave length light for 10-minutes.
Other Names:
  • MitoMIN
Sham Comparator: Beet-root juice plus sham light therapy
Two days prior to the forearm endurance protocol, participants will be provided and instructed to consume a 400mg nitrate once per day. On the day of the forearm endurance protocol, the participants will be provided and instructed to consume a third 400mg dose of nitrates at least 150 minutes before forearm endurance testing.
Other Names:
  • Beet it Sport
Participants will place their dominant forearm 15 centimeters away from the light source and have their dominant forearm exposed to sham light for 10-minutes.
Placebo Comparator: Placebo plus red-light therapy
Participants will place their dominant forearm 15 centimeters away from the light source and have their dominant forearm exposed to 660nm wave length light for 10-minutes.
Other Names:
  • MitoMIN
Two days prior to the forearm endurance protocol, participants will be provided and instructed to consume a nitrate depleted placebo once per day. On the day of the forearm endurance protocol, the participants will be provided and instructed to consume a third dose of the nitrate depleted placebo at least 150 minutes before forearm endurance testing.
Active Comparator: Placebo plus sham light therapy
Participants will place their dominant forearm 15 centimeters away from the light source and have their dominant forearm exposed to sham light for 10-minutes.
Two days prior to the forearm endurance protocol, participants will be provided and instructed to consume a nitrate depleted placebo once per day. On the day of the forearm endurance protocol, the participants will be provided and instructed to consume a third dose of the nitrate depleted placebo at least 150 minutes before forearm endurance testing.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total forearm work performed
Time Frame: During the forearm exercise fatigue protocol lasting up to 45 minutes
Work is the product of the number of times the forearm is activated multiplied by the amount of force produced by the forearm in kilograms.
During the forearm exercise fatigue protocol lasting up to 45 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Forearm endurance
Time Frame: During the forearm exercise fatigue protocol lasting up to 45 minutes
The duration of time the participant takes to complete the forearm fatigue protocol
During the forearm exercise fatigue protocol lasting up to 45 minutes
Intermuscular coordination
Time Frame: During the forearm exercise fatigue protocol lasting up to 45 minutes
Surface electromyography measurements of muscle activity
During the forearm exercise fatigue protocol lasting up to 45 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Andrew D Wells, Ph.D., Wake Forest University, Reynolda Campus

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 9, 2022

Primary Completion (Estimated)

August 31, 2024

Study Completion (Estimated)

August 31, 2024

Study Registration Dates

First Submitted

October 21, 2022

First Submitted That Met QC Criteria

October 26, 2022

First Posted (Actual)

October 27, 2022

Study Record Updates

Last Update Posted (Actual)

March 20, 2024

Last Update Submitted That Met QC Criteria

March 19, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00024675

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

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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