Adjuvant Nitrate to Boost Exercise-induced Health Benefits in Older Adults
Starting soon · Not applicable · Has a placebo group
Conditions studied: Aging, Aging Well, Healthy Aging
In brief
Aging-related functional declines are thought to be caused by hallmark biological processes that ultimately manifest in physical, mental, and metabolic impairments to compromise intrinsic capacity and healthspan. Exercise is the only multipotent treatment with promise to mitigate many of the aging hallmarks, but there is substantial variability in individual exercise responsiveness. Thus, the investigators approach to boosting exercise responsiveness in aging is to combine an exercise training prescription containing both endurance and resistance training (in alignment with DHHS guidelines) with a nitrate-enriched dietary supplement to augment the cellular, tissue, and systemic adaptations that induce myriad health benefits of exercise in older adults.
Key facts
- Study ID
- NCT07572266
- Run by
- Florida Institute for Human and Machine Cognition
- People needed
- 226
- Starts
- 2026-11-01
- Expected to finish
- 2031-05-01
- Last updated by the study team
- 2026-08-10
Who can join
Age: 60 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Male or female aged 60 years or older
- Free of chronic disease or disorder that would preclude full participation or have the potential to confound results
- No structured exercise program (2 or more bouts/wk) within previous 12 months
- Cognitively capable of providing informed consent
You may not qualify if…
- BMI ≥ 30.0 kg/m2
- Neurodegenerative disease
- Neuromuscular, musculoskeletal or orthopedic disorder or condition that would limit ability to perform the exercise prescription and/or physical performance testing
- Diagnosed orthostatic hypotension, i.e., a drop in systolic blood pressure of at least 20 mmHg or a drop in diastolic blood pressure of at least 10 mmHg within three minutes of standing up from a sitting or lying position.
- Resting blood pressure <90/60 mmHg or >160/95 mmHg
- Uncontrolled hypertension
- Any current cardiovascular disease or cardiopulmonary instability
- Recent cardiovascular event or procedure within the preceding 6 months
- If valve replacement has been performed, patient may not be enrolled for 12 months after the procedure
- Any mechanical valve replacement that requires continuous warfarin anti-coagulation
- Anemia: Hgb <11.0 (♂),10.0 (♂) gm/dl
- Diabetes with HgbA1c >7.0% or fasting blood glucose ≥ 130 mg/dl
- Liver disease with ALT > 52 U/l)
- Chronic kidney disease (eGFR < 45)
- Any current infectious disease
- Any other disease or disorder that could influence exercise response, preclude full participation or have the potential to confound results (e.g., chronic lung disease, cognitive impairment, current cancer diagnosis or within 2 yr remission, cerebrovascular disease, pain)
- Life expectancy < 1 year Medications / lifestyle
- Insulin sensitizing/blood glucose lowering agents such as metformin
- Currently on or have used GLP-1 agonist or other metabolic / weight loss drug in previous 12 weeks
- Use of nitrate medications
- High dose statin (≥40 mg/d simvastatin equivalence)
- Chronic corticosteroids
- Testosterone or other anabolic/androgenic hormone therapy
- Lidocaine allergy
- Regular tobacco use and/or vaping > 1/wk
Where it is running
- Florida Institute for Human and Machine Cognition — Pensacola, Florida, United States
Full record on ClinicalTrials.gov
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