Status:

NOT_YET_RECRUITING

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

Lead Sponsor:

Indiana University

Conditions:

Mitochondrial Energetics

Dietary Nitrate

Eligibility:

MALE

18-44 years

Phase:

NA

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 ...

Detailed Description

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 ...

Eligibility Criteria

Inclusion

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

Exclusion

  • 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
  • An answer of yes to any of the seven questions on the first page of the Physical Activity Readiness Questionnaire (PAR-Q. These exclusions include the following:
  • 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
  • In past month, chest pain when not doing physical activity
  • If participant has ever lost balance because of dizziness or has ever lost consciousness
  • Muscle, bone, or joint problem that could be made worse by physical activity
  • Currently on prescribed drugs for blood pressure or heart condition.
  • If the participant knows of any other reason he/she should not do physical activity.

Key Trial Info

Start Date :

January 1 2026

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

December 31 2026

Estimated Enrollment :

24 Patients enrolled

Trial Details

Trial ID

NCT07161973

Start Date

January 1 2026

End Date

December 31 2026

Last Update

December 22 2025

Active Locations (1)

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1

Indiana University Indianapolis

Indianapolis, Indiana, United States, 46202