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

Sponsor
Wake Forest University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05596474
Collaborator
(none)
10
Enrollment
1
Location
4
Arms
15.7
Anticipated Duration (Months)
0.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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?

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: Beet-root juice
  • Radiation: red-light therapy
  • Dietary Supplement: Placebo
  • Radiation: sham light
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
10 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Single (Participant)
Primary Purpose:
Basic Science
Official Title:
Application of Beet-root Juice Supplementation and Photobiomodulation Treatment on Forearm Muscle Fatigue in Older Adults
Actual Study Start Date :
Sep 9, 2022
Anticipated Primary Completion Date :
Aug 31, 2023
Anticipated Study Completion Date :
Dec 31, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Beet-root juice plus red-light therapy

Dietary Supplement: Beet-root juice
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

    • Radiation: 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

    		•
    Sham Comparator: Beet-root juice plus sham light therapy

    Dietary Supplement: Beet-root juice
    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

    • Radiation: sham light
    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

    Radiation: 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

    • Dietary Supplement: Placebo
    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

    Dietary Supplement: Placebo
    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.

    Radiation: sham light
    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.

    Outcome Measures

    Primary Outcome Measures

    1. Total forearm work performed [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.

    Secondary Outcome Measures

    1. Forearm endurance [During the forearm exercise fatigue protocol lasting up to 45 minutes]

      The duration of time the participant takes to complete the forearm fatigue protocol

    2. Intermuscular coordination [During the forearm exercise fatigue protocol lasting up to 45 minutes]

      Surface electromyography measurements of muscle activity

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    65 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Wake Forest Univesity Winston-Salem North Carolina United States 27106

    Sponsors and Collaborators

    • Wake Forest University

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Andrew Wells, Principal Investigator, Wake Forest University
    ClinicalTrials.gov Identifier:
    NCT05596474
    Other Study ID Numbers:
    • IRB00024675
    First Posted:
    Oct 27, 2022
    Last Update Posted:
    Nov 1, 2022
    Last Verified:
    Oct 1, 2022
    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
    Keywords provided by Andrew Wells, Principal Investigator, Wake Forest University
    Red light therapy
    Forearm muscle endurance
    Beet-root juice
    Electromyography
    Additional relevant MeSH terms:
    Fatigue

    Study Results

    No Results Posted as of Nov 1, 2022