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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05596474
Other study ID # IRB00024675
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date September 9, 2022
Est. completion date August 31, 2024

Study information

Verified date March 2024
Source Wake Forest University
Contact Andrew D Wells, Ph.D.
Phone (336) 758-5837
Email wellsa@wfu.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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?


Recruitment information / eligibility

Status Recruiting
Enrollment 10
Est. completion date August 31, 2024
Est. primary completion date August 31, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 65 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.
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.
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.

Locations

Country Name City State
United States Wake Forest Univesity Winston-Salem North Carolina

Sponsors (1)

Lead Sponsor Collaborator
Wake Forest University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Forearm endurance The duration of time the participant takes to complete the forearm fatigue protocol During the forearm exercise fatigue protocol lasting up to 45 minutes
Secondary Intermuscular coordination Surface electromyography measurements of muscle activity During the forearm exercise fatigue protocol lasting up to 45 minutes
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