Effect of Dietary Nitrate on Immobilization-induced Changes in Skeletal Muscle in Young Healthy Men

Part of paid clinical trials in Indianapolis, Indiana.

Sponsor
Indiana University
Study ID
NCT07161973
Status
Recruiting
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Conditions

  • Dietary Nitrate
  • Disuse Atrophy (Muscle) of Lower Leg
  • Mitochondrial Energetics

Eligibility Criteria

Sex
MALE
Age
18 Years - 44 Years
Healthy Volunteers
Accepted

Interventions

  • Beetroot Juice - Active — DIETARY_SUPPLEMENT
    Nitrate-rich beetroot juice
  • Placebo Beetroot Juice Without Nitrate — DIETARY_SUPPLEMENT
    Nitrate-free beetroot juice

Study Details

Diminished use of skeletal muscle, such as occurs with many chronic diseases (e.g., heart failure or cancer cachexia), denervation, bedrest, immobilization (e.g., limb casting or bracing), etc., is a common clinical condition affecting untold millions of individuals each year. Such disuse leads to a rapid decline in muscle fiber area and hence whole muscle size, contributing to a decrease in strength, speed, and power as well as alterations in energy metabolism. Collectively, these changes lead to reduced physical function and contribute to the seriousness of any disease, illness (e.g., pneumonia), surgery (e.g., joint replacement), or injury (e.g., broken bone) accompanied by decreased muscular activity. Currently, there are no effective pharmacological treatments to prevent disuse-associated muscle wasting in humans. The above-described effects of disuse appear to be due, at least in part, to a decrease in nitric oxide (NO) bioavailability. Reduced synthesis of NO and/or increased NO destruction (due to increased production of oxygen free radicals) likely contributes to the mitochondrial changes, energetic abnormalities, and muscle atrophy resulting from immobilization. The objective of this study is to investigate the potential benefits of dietary nitrate supplementation on immobilization-induced changes in muscle contractile function and mitochondrial respiratory capacity in young healthy men. Our disuse-induced muscle atrophy model will involve wearing a knee brace for a period of 14 d.

Key Dates

Start date
Jan 30, 2026
Status verified
Feb 2026
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
24 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Nitrate
    Nitrate-rich beetroot juice
  • Placebo Comparator: Placebo
    Nitrate-free beetroot juice

Primary Outcome Measure

Muscle mitochondrial function [ Time Frame: 14 days ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Indiana University IndianapolisIndianapolisIndiana46202
Andrew R Coggan, PhD
[email protected]
317-274-0656
William S Zoughaib, BS
[email protected]
Andrew R Coggan, PhD (PRINCIPAL_INVESTIGATOR)

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