← Back to all trials
Not Yet Recruiting
NCT07572266
Adjuvant Nitrate to Boost Exercise-induced Health Benefits in Older Adults
Conditions: Aging, Aging Well, Healthy Aging
Sex: All
Ages: 60 Years – N/A
Healthy volunteers: Yes
Phase: NA
Enrollment: 226
Sponsor: Florida Institute for Human and Machine Cognition
Location: Florida Institute for Human and Machine Cognition Pensacola Florida
Summary
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.
Eligibility Criteria
Inclusion Criteria:
1. Male or female aged 60 years or older
2. Free of chronic disease or disorder that would preclude full participation or have the potential to confound results
3. No structured exercise program (2 or more bouts/wk) within previous 12 months
4. Cognitively capable of providing informed consent
Exclusion Criteria:
1. BMI ≥ 30.0 kg/m2
2. Neurodegenerative disease
3. Neuromuscular, musculoskeletal or orthopedic disorder or condition that would limit ability to perform the exercise prescription and/or physical performance testing
4. 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.
5. Resting blood pressure \160/95 mmHg
6. Uncontrolled hypertension
7. Any current cardiovascular disease or cardiopulmonary instability
8. Recent cardiovascular event or procedure within the preceding 6 months
1. If valve replacement has been performed, patient may not be enrolled for 12 months after the procedure
2. Any mechanical valve replacement that requires continuous warfarin anti-coagulation
9. Anemia: Hgb \7.0% or fasting blood glucose ≥ 130 mg/dl
11. Liver disease with ALT \> 52 U/l)
12. Chronic kidney disease (eGFR \< 45)
13. Any current infectious disease
14. 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)
15. Life expectancy \< 1 year Medications / lifestyle
16. Insulin sensitizing/blood glucose lowering agents such as metformin
17. Currently on or have used GLP-1 agonist or other metabolic / weight loss drug in previous 12 weeks
18. Use of nitrate medications
19. High dose statin (≥40 mg/d simvastatin equivalence)
20. Chronic corticosteroids
21. Testosterone or other anabolic/androgenic hormone therapy
22. Lidocaine allergy
23. Regular tobacco use and/or vaping \> 1/wk
24. Use of cannabis \> 1/wk
25. Excessive alcohol consumption (3 drinks/d or 7 drinks/wk for females; 4 drinks/d or 14 drinks/wk for males)
26. Use of illicit drugs (e.g., cocaine, opioids)
27. Unable to commit to \~4 months required to complete the study
Source: ClinicalTrials.gov (NCT07572266). StuddyBuddy aggregates publicly available trial information.