- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05596474
Effect of Beet-root Juice and PBM Treatments on Muscle Fatigue
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
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
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
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
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
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:
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:
|
|
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:
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:
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
Sponsor
Investigators
- Principal Investigator: Andrew D Wells, Ph.D., Wake Forest University, Reynolda Campus
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
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
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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