Phase 1
Completed N=13
Dose-response Effect of Dietary Nitrate on Muscle Function in Older Individuals
Source: ClinicalTrials.gov NCT03595774 ↗Enrolled (actual)
13
Serious AEs
0.0%
Results posted
Jul 2024
Primary outcomePrimary: Maximal Knee Extensor Velocity — 10.83; 11.91; 11.24 rad/s — p=0.0833
Summary
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maximal Knee Extensor Velocity |
10.83; 11.91; 11.24 | 0.0833 |
| PRIMARY Maximal Knee Extensor Power |
3.74; 3.92; 3.69 | 0.0131 sig |
| SECONDARY Plasma Nitrite |
.306; 40; .341; .299; .459; .478 | 0.012728 sig |
| SECONDARY Plasma Nitrate |
55; 40; 34; 57; 523; 793 | 0.00000002 sig |
| SECONDARY Breath Nitric Oxide |
19; 18; 18; 22; 39; 31 | 0.017215 sig |
Eligibility Criteria
Inclusion Criteria
- 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)
Exclusion Criteria
- Men and women 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
Data sourced from ClinicalTrials.gov (NCT03595774). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.