Health Care UtilizationNCT05596474
Effect of Beet-root Juice and PBM Treatments on Muscle Fatigue
A study testing Beet-root juice and red-light therapy in people with Health Care Utilization and Healthy Aging, run by Wake Forest University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Health Care Utilization, Healthy Aging
- What is being tested?
- Beet-root juice and red-light therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Sep 2022to 31 Aug 2024
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Self-reports performing at least 30 minutes of light to moderate intensity physical activity 3 times per week for the last three months
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Wake Forest Univesity
Winston-Salem, North Carolina, 27106
Andrew D Wells, Ph.D., 336-758-5837 ext. 2156, wellsa@wfu.edu
About this study
Official title: 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?
- Conditions
- Health Care Utilization, Healthy Aging
- Being tested
- Beet-root juice, red-light therapy, Placebo, sham light
- Keywords
- Red light therapy, Forearm muscle endurance, Beet-root juice, Electromyography
- Medical subject headings
- Patient Acceptance of Health Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Beet-root juiceDietary supplement
Also called Beet it Sport
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.
red-light therapyRadiation
Also called MitoMIN
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.
PlaceboDietary supplement
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.
sham lightRadiation
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.
| Study group | Role | What they receive |
|---|---|---|
| Beet-root juice plus red-light therapy | Experimental | Not described Receives: Dietary Supplement: Beet-root juice; Radiation: red-light therapy |
| Beet-root juice plus sham light therapy | Sham comparator | Not described Receives: Dietary Supplement: Beet-root juice; Radiation: sham light |
| Placebo plus red-light therapy | Placebo comparator | Not described Receives: Radiation: red-light therapy; Dietary Supplement: Placebo |
| Placebo plus sham light therapy | Active comparator | Not described Receives: Dietary Supplement: Placebo; Radiation: sham light |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: During the forearm exercise fatigue protocol lasting up to 45 minutes
Secondary outcomes (2)
Forearm endurance
The duration of time the participant takes to complete the forearm fatigue protocol
Measured: During the forearm exercise fatigue protocol lasting up to 45 minutes
Intermuscular coordination
Surface electromyography measurements of muscle activity
Measured: During the forearm exercise fatigue protocol lasting up to 45 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2022
- Study start9 Sep 2022
- Primary completion31 Aug 2024 (estimated)
- Study completion31 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Health Care UtilizationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wake Forest University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrew Wells, Ph.D, Wake Forest University
- Investigators
- Andrew D Wells, Ph.D., Principal investigator, Wake Forest University, Reynolda Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05596474
- Sponsor's protocol ID
- IRB00024675
- Status last verified
- Mar 2024
- First submitted
- 21 Oct 2022
- Last updated
- 20 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of Beet-root Juice Supplementation and Photobiomodulation Treatment on Forearm Muscle Fatigue in Older Adults
- ClinicalTrials.gov ID
- NCT05596474
- Acronym / sponsor ID
- IRB00024675
- Conditions
- Health Care Utilization, Healthy Aging
- Keywords
- Red light therapy, Forearm muscle endurance, Beet-root juice, Electromyography
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Wake Forest UniversityUniversity, hospital or other
- Study start
- 9 Sep 2022 (actual)
- Primary completion
- 31 Aug 2024 (estimated)
- Study completion
- 31 Aug 2024 (estimated)
- First posted
- 27 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Beet-root juice plus red-light therapy | Experimental | Dietary Supplement: Beet-root juice, Radiation: red-light therapy |
| Beet-root juice plus sham light therapy | Sham comparator | Dietary Supplement: Beet-root juice, Radiation: sham light |
| Placebo plus red-light therapy | Placebo comparator | Radiation: red-light therapy, Dietary Supplement: Placebo |
| Placebo plus sham light therapy | Active comparator | Dietary Supplement: Placebo, Radiation: sham light |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- Self-reports performing at least 30 minutes of light to moderate intensity physical activity 3 times per week for the last three months
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Beet-root juiceAlso: Beet it SportTwo 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. | Dietary supplement | Beet-root juice plus red-light therapy, Beet-root juice plus sham light therapy |
| red-light therapyAlso: MitoMINParticipants 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. | Radiation | Beet-root juice plus red-light therapy, Placebo plus red-light therapy |
| PlaceboTwo 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. | Dietary supplement | Placebo plus red-light therapy, Placebo plus sham light therapy |
| sham lightParticipants will place their dominant forearm 15 centimeters away from the light source and have their dominant forearm exposed to sham light for 10-minutes. | Radiation | Beet-root juice plus sham light therapy, Placebo plus sham light therapy |
Primary outcome
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.
2 secondary outcomes
Forearm endurance
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Andrew D Wells, Ph.D. principal investigator
Wake Forest University, Reynolda Campus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Beet-root juice and red-light therapy in people with Health Care Utilization and Healthy Aging, run by Wake Forest University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Andrew D Wells, Ph.D. ((336) 758-5837 ext. 2156, wellsa@wfu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total forearm work performed (time frame: During the forearm exercise fatigue protocol lasting up to 45 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2024.