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

NCT05596474 | Recruiting FDA Device

• 1 other identifier: IRB00024675
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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?

Conditions

Health Care Utilization; Healthy Aging

Keywords

Red light therapy; Forearm muscle endurance; Beet-root juice; Electromyography

Outcome Measures

Primary Outcomes (1)

• 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.

  During the forearm exercise fatigue protocol lasting up to 45 minutes

Secondary Outcomes (2)

• Forearm endurance

  During the forearm exercise fatigue protocol lasting up to 45 minutes

• Intermuscular coordination

  During the forearm exercise fatigue protocol lasting up to 45 minutes

Study Arms (4)

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

Interventions

Beet-root juice DIETARY_SUPPLEMENT

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.

Also known as: Beet it Sport

Beet-root juice plus red-light therapy; Beet-root juice plus sham light therapy

red-light therapy RADIATION

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.

Also known as: MitoMIN

Beet-root juice plus red-light therapy; Placebo plus red-light therapy

Placebo DIETARY_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.

Placebo plus red-light therapy; Placebo plus sham light therapy

sham light RADIATION

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.

Beet-root juice plus sham light therapy; Placebo plus sham light therapy

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Wake Forest University: lead

Study Sites (1)

Wake Forest Univesity

Winston-Salem, North Carolina, 27106, United States

RECRUITING

MeSH Terms

Conditions

Patient Acceptance of Health Care

Condition Hierarchy (Ancestors)

Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Andrew D Wells, Ph.D.

  Wake Forest University, Reynolda Campus

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Andrew D Wells, Ph.D.

CONTACT

(336) 758-5837; wellsa@wfu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 21, 2022
• First Posted: October 27, 2022
• Study Start: September 9, 2022
• Primary Completion: August 31, 2024
• Study Completion: August 31, 2024
• Last Updated: March 20, 2024

Record last verified: 2024-03

Locations

US (1)