Adjuvant Nitrate to Boost Exercise-induced Health Benefits in Older Adults
Part of paid clinical trials in Pensacola, Florida.
- Sponsor
- Florida Institute for Human and Machine Cognition
- Study ID
- NCT07572266
- Status
- Not Yet Recruiting
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Conditions
- Aging
- Aging Well
- Healthy Aging
Eligibility Criteria
- Sex
- ALL
- Age
- 60 Years - N/A
- Healthy Volunteers
- Accepted
Interventions
- Nitrate enriched beetroot juice — DIETARY_SUPPLEMENTParticipants 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.
- Nitrate depleted beetroot juice — DIETARY_SUPPLEMENTManufacturer-matched placebo that is nitrate-depleted beetroot juice (70 ml per drink). Both nitrate and placebo will be purchased from Beet It.
- 12 week of combined exercise training — OTHERAll 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.
Study Details
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 Dates
- Start date
- May 31, 2026
- Status verified
- Apr 2026
- Primary completion
- May 31, 2031
- Completion
- May 31, 2031
Study Design
- Enrollment
- 226 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- SEQUENTIAL
- Primary purpose
- TREATMENT
Arms
- Experimental: Nitrate GroupParticipants 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.
- Placebo Comparator: Placebo GroupParticipants will be randomized to an intervention in which they take 800 mg (2 x 400 mg) nitrate-deprived, manufacturer-matched beetroot juice drink \[Beet It Sport Nitrate 400 (70 ml per drink)\]. Both nitrate and placebo will be purchased from Beet It.
Primary Outcome Measure
Assess the clinical impact of nitrate supplementation on a proportion of older adults attaining exercise-induced health benefits. [ Time Frame: 12 weeks ]
Central Contacts
- Craig Tuggle, MA850-202-4416
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Florida Institute for Human and Machine Cognition | Pensacola | Florida | 32502 | - |
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