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NCT07572266

Adjuvant Nitrate to Boost Exercise-induced Health Benefits in Older Adults

Sponsor: Florida Institute for Human and Machine Cognition

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

60 Years - Any

Study Type

INTERVENTIONAL

Enrollment

226

Start Date

2026-07

Completion Date

2031-05

Last Updated

2026-07-10

Healthy Volunteers

Yes

Conditions

Aging Aging Well Healthy Aging

Interventions

DIETARY_SUPPLEMENT

Nitrate enriched beetroot juice

Participants will be randomized to an intervention in which they take 800 mg (2 x 400 mg) nitrate-enriched beetroot juice drink \[Beet It Sport Nitrate 400 (70 ml per drink)\]. Both nitrate and placebo will be purchased from Beet It.

DIETARY_SUPPLEMENT

Nitrate depleted beetroot juice

Manufacturer-matched placebo that is nitrate-depleted beetroot juice (70 ml per drink). Both nitrate and placebo will be purchased from Beet It.

OTHER

12 week of combined exercise training

All participants: An exercise dose will be composed of 12 wk of 3d/wk laboratory based supervised prescribed with strategic variations in intensity, volume, and modality across the 3 weekly sessions. During Monday and Friday RT sessions, participants complete 3 sets x 8-12 reps to volitional fatigue for leg press, knee extension, leg curl, overhead press, lat pulldown or row, and chest press in superset fashion with a 60 s rest between supersets. On Wednesday, participants perform 2 sets of 13-15 reps of leg press, knee extension, chest press and lat pulldowns with specific cues for speed and fast contractions. RT is complemented by the ET component which follows a Moderate-High Moderate intensity schedule with 30 min of 70-75% HRR steady state cycling on Monday and Friday separated by a Wednesday 20 min high intensity interval session on a cycle ergometer (1 min on/off; 10 cycles) at near maximal intensity with a target of 90% HRR.

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 \<90/60 mmHg or \>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 \<11.0 (♂),10.0 (♂) gm/dl 10. Diabetes with HgbA1c \>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

Locations (1)

Florida Institute for Human and Machine Cognition

Pensacola, Florida, United States