Back to resultsEffect of Beet-root Juice and PBM Treatments on Muscle Fatigue
Primary Purpose
Health Care Utilization, Healthy Aging
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Beet-root juice
red-light therapy
Placebo
sham light
Sponsored by
About this trial
This is an interventional basic science trial for Health Care Utilization focused on measuring Red light therapy, Forearm muscle endurance, Beet-root juice, Electromyography
Eligibility Criteria
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
Sites / Locations
- Wake Forest UnivesityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Sham Comparator
Placebo Comparator
Active Comparator
Arm Label
Beet-root juice plus red-light therapy
Beet-root juice plus sham light therapy
Placebo plus red-light therapy
Placebo plus sham light therapy
Arm Description
Outcomes
Primary Outcome Measures
Total forearm work performed
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
Forearm endurance
The duration of time the participant takes to complete the forearm fatigue protocol
Intermuscular coordination
Surface electromyography measurements of muscle activity
Full Information
NCT ID
NCT05596474
First Posted
October 21, 2022
Last Updated
October 27, 2022
Sponsor
Wake Forest University
1. Study Identification
Unique Protocol Identification Number
NCT05596474
Brief Title
Effect of Beet-root Juice and PBM Treatments on Muscle Fatigue
Official Title
Application of Beet-root Juice Supplementation and Photobiomodulation Treatment on Forearm Muscle Fatigue in Older Adults
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 9, 2022 (Actual)
Primary Completion Date
August 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Wake Forest University
4. Oversight
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
Data Monitoring Committee
No
5. 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?
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Health Care Utilization, Healthy Aging
Keywords
Red light therapy, Forearm muscle endurance, Beet-root juice, Electromyography
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
10 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Beet-root juice plus red-light therapy
Arm Type
Experimental
Arm Title
Beet-root juice plus sham light therapy
Arm Type
Sham Comparator
Arm Title
Placebo plus red-light therapy
Arm Type
Placebo Comparator
Arm Title
Placebo plus sham light therapy
Arm Type
Active Comparator
Intervention Type
Dietary Supplement
Intervention Name(s)
Beet-root juice
Other Intervention Name(s)
Beet it Sport
Intervention Description
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.
Intervention Type
Radiation
Intervention Name(s)
red-light therapy
Other Intervention Name(s)
MitoMIN
Intervention Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
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.
Intervention Type
Radiation
Intervention Name(s)
sham light
Intervention Description
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.
Primary Outcome Measure Information:
Title
Total forearm work performed
Description
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.
Time Frame
During the forearm exercise fatigue protocol lasting up to 45 minutes
Secondary Outcome Measure Information:
Title
Forearm endurance
Description
The duration of time the participant takes to complete the forearm fatigue protocol
Time Frame
During the forearm exercise fatigue protocol lasting up to 45 minutes
Title
Intermuscular coordination
Description
Surface electromyography measurements of muscle activity
Time Frame
During the forearm exercise fatigue protocol lasting up to 45 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Andrew D Wells, Ph.D.
Phone
(336) 758-5837
Ext
2156
Email
wellsa@wfu.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrew D Wells, Ph.D.
Organizational Affiliation
Wake Forest University, Reynolda Campus
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wake Forest Univesity
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27106
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andrew D Wells, Ph.D.
Phone
336-758-5837
Ext
2156
Email
wellsa@wfu.edu
12. IPD Sharing Statement
Learn more about this trial
Effect of Beet-root Juice and PBM Treatments on Muscle Fatigue
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