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

NCT07161973 | Recruiting

• 1 other identifier: 28101
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Keywords

Dietary Nitrate; Immobilization

Outcome Measures

Primary Outcomes (1)

• Muscle mitochondrial function

  Muscle mitochondrial respiratory capacity assessed in vitro using high resolution respirometry and in vivo using a near infrared spectroscopy/occlusion protocol

  14 days

Secondary Outcomes (3)

• Muscle strength

  14 days

• Muscle speed

  14 days

• Muscle power

  14 days

Study Arms (2)

Nitrate

EXPERIMENTAL

Nitrate-rich beetroot juice

Dietary Supplement: Beetroot Juice - Active

Placebo

PLACEBO COMPARATOR

Nitrate-free beetroot juice

Dietary Supplement: Placebo Beetroot Juice Without Nitrate

Interventions

Beetroot Juice - Active DIETARY_SUPPLEMENT

Nitrate-rich beetroot juice

Nitrate

Placebo Beetroot Juice Without Nitrate DIETARY_SUPPLEMENT

Nitrate-free beetroot juice

Placebo

Eligibility Criteria

• Age: 18 Years - 44 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Men age 18-44
• Above the minimum threshold of the IPAQ questionnaire
• Below the maximum threshold of the IPAQ questionnaire

You may not qualify if:

• Men and women \<18 or \>44 years of age
• Unable to provide informed consent
• Known clotting disorder
• Previous history of deep vein thrombosis
• Injury to either leg resulting in reduced mobility in the previous year
• Currently dieting or weight instability for the past 3 months
• Epileptic
• Pacemaker or other implantable heart device
• Currently taking antibiotics
• Current smoker
• Stage II hypertension (resting blood pressure \>140/\>90)
• Previously undergone a revascularization procedure involving a vascular graft or stenting of the femoral or popliteal arteries
• Those taking phosphodiesterase inhibitors (e.g., Viagra), proton pump inhibitors, antacids, xanthine oxidase inhibitors, hormonal contraceptives or on hormone replacement therapy
• If participant's doctor has ever said that he/she has a heart condition and that he/she should only do physical activity recommended by a doctor
• Pain in chest when doing physical activity

Sponsors & Collaborators

• Indiana University: lead

Study Sites (1)

Indiana University Indianapolis

Indianapolis, Indiana, 46202, United States

RECRUITING

MeSH Terms

Conditions

Muscular Disorders, Atrophic

Interventions

Nitrates

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Anions; Ions; Electrolytes; Inorganic Chemicals; Nitric Acid; Nitrogen Compounds; Organic Chemicals

Study Officials

• Andrew R Coggan, PhD

  Indiana University Indianapolis

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Andrew R Coggan, PhD

CONTACT

317-274-0656; acoggan@iu.edu

William S Zoughaib, BS

CONTACT

wzoughai@iu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: August 8, 2025
• First Posted: September 9, 2025
• Study Start: January 30, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: February 23, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Time Frame: Data will be made available upon completion of the study and publication of the final results.

Locations

US (1)