Adjuvant Nitrate to Boost Exercise-induced Health Benefits in Older Adults
BOOST-X
1 other identifier
interventional
226
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2026
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 17, 2026
CompletedStudy Start
First participant enrolled
May 1, 2026
CompletedFirst Posted
Study publicly available on registry
May 7, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2031
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 1, 2031
May 7, 2026
April 1, 2026
5 years
April 17, 2026
April 30, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Assess the clinical impact of nitrate supplementation on a proportion of older adults attaining exercise-induced health benefits.
The primary outcome will be assessed using logistic regression with the proportion not attaining Cardiorespiratory Fitness and functional Muscle Quality Minimally Clinical Differences as the response variable and treatment adjusted for sex and age group across the 12 week intervention.
12 weeks
Secondary Outcomes (6)
Cardiorespiratory demand during submaximal cycle exercise.
12 weeks
Neuromuscular fatiguability during isometric holds.
12 weeks
10 meter max gait speed.
12 weeks
modified Balance Error Scoring System (mBESS)
12 weeks
NIH PROMIS Physical Function SF
12 weeks
- +1 more secondary outcomes
Other Outcomes (4)
Cognitive function.
12 weeks
Psychological state.
12 weeks
Sleep quality and nocturnal stress.
12 weeks
- +1 more other outcomes
Study Arms (2)
Nitrate Group
EXPERIMENTALParticipants 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 Group
PLACEBO COMPARATORParticipants 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.
Interventions
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.
Manufacturer-matched placebo that is nitrate-depleted beetroot juice (70 ml per drink). Both nitrate and placebo will be purchased from Beet It.
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.
Eligibility Criteria
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
- +14 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Florida Institute for Human and Machine Cognition
Pensacola, Florida, 32502, United States
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Masking Details
- Participants will be randomized in double-blind fashion to consume 2x/day nitrate-rich beetroot juice (Beet-it®, 400 mg inorganic nitrate per dose x 2/day) or nitrate-depleted placebo beetroot juice. To bolster trial rigor, the placebo is also produced by Beet-it®, is taste- and volume-matched, contains all other potentially bioactive ingredients sans nitrate, and active vs. placebo bottles are indistinguishable. The blind will be held by independent research staff not involved in the study. Daily consumption of each dose will be closely monitored via a phone-based logging app integrated with the electronic DEMS. The app also enables research staff to push reminders to participants as needed. Participant tolerance has not been a concern in our prior and ongoing studies. However, the investigators will monitor individual tolerance and address any issues on a case-by-case basis.
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 17, 2026
First Posted
May 7, 2026
Study Start
May 1, 2026
Primary Completion (Estimated)
May 1, 2031
Study Completion (Estimated)
May 1, 2031
Last Updated
May 7, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR
- Time Frame
- Data share will begin when as soon as first data collections begin. Sub award sites will enter participant data on the secure Data Entry Management System (DEMS). Data shares will continue until the close of study.
- Access Criteria
- Access to all study data is granted on the researcher regulatory training and local IRB approval.
De-identified phenotyping data will be made accessible through supplementary data tables and files alongside manuscript publication or via third-party repositories. This data will also be hosted on secure server space without any link to PHI and made accessible through a publicly available Shiny app. Primary cell aliquots and biobanked snap frozen muscle and/or frozen blood samples will be provided to investigators upon reasonable request along with de-identified metadata.