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Nitrites, Skeletal Muscle Mitochondrial Bioenergetics, and Physical Activity in Old Age

NCT04405180 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2024-10-10

Study results available
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Summary

This 2-site randomized double blinded controlled trial is to confirm and more definitively clarify the impact of a 12-week course of nitrite versus placebo on mitochondrial bioenergetics in older sedentary adults. This investigator will take an integrative physiology approach to determine the effect of nitrite therapy on a comprehensive assessment of mitochondrial energetics, skeletal muscle vascular function, and whole body physical function (cardiorespiratory function, exercise endurance, strength, balance, and physical activity) and fatigability.

Conditions

  • Aging
  • Sedentary Lifestyle
  • Frailty

Interventions

DRUG

Placebos

Oral placebo capsule at a dose of 20 mg administered three times per day, during the day.

DRUG

20mg sodium nitrite tid

Oral, inorganic sodium nitrite capsule at a dose of 20 mg administered three times per day, during the day.

Sponsors & Collaborators

  • National Institutes of Health (NIH)

    collaborator NIH

  • National Institute on Aging (NIA)

    collaborator NIH

  • Gladwin, Mark, MD

    lead INDIV

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-23
Primary Completion
2023-07-14
Completion
2023-07-14
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04405180 on ClinicalTrials.gov