Dose-response Effect of Dietary Nitrate on Muscle Function in Older Individuals

Completed · Phase 1 · Has a placebo group

Conditions studied: Aging, Sarcopenia

In brief

Nitrate is a naturally-occurring substance found in foods, especially green leafy vegetables and beets. Increasing nitrate intake (by drinking beetroot juice (BRJ) has been shown to improve muscle function young and middle-aged subjects, athletes, and patients with heart failure. The purpose of this study is to determine whether dietary nitrate provides a similar benefit in older individuals, and if so, the optimal dose. We will be comparing the effects of ingesting BRJ containing a smaller or greater amount of nitrate versus the effects of a placebo (BRJ from which the nitrate has been removed).

Key facts

Study ID

NCT03595774

Run by

Indiana University

People needed

13

Starts

2018-09-01

Expected to finish

2021-07-31

Last updated by the study team

2024-07-29

Who can join

Age: 65 and older, up to 79. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• In good health, as determined by the investigator's review of history (provided by subject at screening visit), physical examination, and routine blood and urine tests (done at screening visit)

You may not qualify if…

• Men and women <65 or >79 years of age
• Unable to provide informed consent
• Currently pregnant or lactating (given the age range for the study, verbal confirmation by subject is believed to be sufficient)
• Current smokers
• Significant orthopedic limitations or other contraindications to strenuous exercise
• Those taking phosphodiesterase inhibitors (e.g., Viagra)
• Those taking proton pump inhibitors, antacids, xanthine oxidase inhibitors, or on hormone replacement therapy
• Those taking anti-coagulants (e.g., Coumadin) or on anti-platelet therapy
• History of neuromuscular disease (e.g., cervical spondylotic radiculomyelpathy, lumbar spondylosis, amyotrophic lateral sclerosis, Guillain-Barré syndrome, and acquired demyelinating polyneuropathies), cardiovascular disease (e.g., > stage I hypertension, heart failure, myocardial infarction/ischemia, significant myocardial or pericardial diseases (e.g. amyloidosis, constriction), moderate or severe valvular disease, renal disease, liver disease, or anemia

Where it is running

• Indiana University School of Health and Human Sciences — Indianapolis, Indiana, United States

Full record on ClinicalTrials.gov

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