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AgingBOOST-XNCT07572266

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

A study testing Nitrate enriched beetroot juice, Nitrate depleted beetroot juice and 12 week of combined exercise training in people with Aging and Aging Well, run by Florida Institute for Human and Machine Cognition at 1 site in United States.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 60 years and olderHealthy volunteers can take part
Conditions the study is for
Aging, Aging Well, Healthy Aging
What is being tested?
Nitrate enriched beetroot juice, Nitrate depleted beetroot juice and 12 week of combined exercise training
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
226 participants
Where
1 siteUnited States
Study dates
Nov 2026to May 2031
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 29Show fewer
  • 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
  • Use of cannabis > 1/wk
  • Excessive alcohol consumption (3 drinks/d or 7 drinks/wk for females; 4 drinks/d or 14 drinks/wk for males)
  • Use of illicit drugs (e.g., cocaine, opioids)
  • Unable to commit to ~4 months required to complete the study

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Craig Tuggle, MA contact

850-202-4416

ctuggle@ihmc.org

United States1 site
  • Florida Institute for Human and Machine Cognition

    Pensacola, Florida, 32502

Other trials in United States

About this study

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.

Read the detailed description

Aging-related declines in health and intrinsic capacity are linked to biological processes profoundly affecting all organ systems and tissues including skeletal muscle. Exercise is a multipotent countermeasure to these processes. However, there is significant inter-individual response heterogeneity (IRH) in the magnitude of exercise-induced health benefits. Boosting exercise responsiveness among older adults is thus a top priority. The investigators have found in older adults that supplementation with nitric oxide (NO) precursors nitrate and nitrite is safe, well tolerated, and improves: (i) physical performance; (ii) vascular endothelial function; (iii) mitochondrial function; (iv) oxidative stress; and (v) muscle inflammation. The investigators suspect deficits among some older adults in nitrate bioavailability and/or exercise-induced NO production may in part drive suboptimal exercise responsiveness. Given the powerful and sustaining impact of exercise-induced health benefits on morbidity and mortality, the investigator's fundamental premise is that exercise responsiveness of every older adult should be maximized. In the BOOST-X Trial the investigators will determine if increasing nitrate bioavailability via dietary supplementation is an efficacious approach to more older adults attaining these essential health benefits. Low cardiorespiratory fitness (CRF, VO2max) and low functional muscle quality (fMQ; strength/muscle mass) are multi-system manifestations of degenerative aging that include vascular endothelial and mitochondrial dysfunction, oxidative stress, and inflammation. CRF and fMQ are modifiable with endurance (ET) and resistance (RT) training. This planned trial will be the first to evaluate the efficacy of coupling a nitrate-rich nutritional supplement with a combined ET+RT prescription in line with DHHS weekly exercise guidelines. The investigators will test the central hypothesis that daily nitrate supplementation will augment exercise training-induced gains in CRF and fMQ accompanied by improvements in vascular endothelial and mitochondrial function. Aim 1: Assess the clinical impact of nitrate supplementation on the proportion of older adults attaining exercise-induced health benefits. N=226 participants stratified by sex and age group (60-69 vs ≥70 y) with random assignment to nitrate (400 mg, 2x/day) (n=113) vs. placebo (nitratedepleted) (n=113) during 12 wk of 3x/wk ET+RT. 1˚ Outcomes: MCID attainment for CRF and fMQ. Expected Results: Daily nitrate will reduce the proportion of older adults not attaining CRF and fMQ MCIDs by a full 1/3. Aim 2: Assess potential mechanisms underpinning adaptations to exercise +/- nitrate supplementation. The investigators will test/integrate in vivo, ex vivo, in vitro and molecular mapping assays considered central to exercise +/- nitrate adaptations and leverage a multidimensional learning framework to better understand the biocircuitry underpinning MCID attainment. 1˚ Outcomes: Vascular endothelial function, muscle mitochondrial function. Expected Results: MCID attainment will be closely linked to improvements in vascular endothelial function and muscle mitochondrial function. The acute molecular responses to exercise will be differentially regulated by nitrate supplementation, and the novel biocircuitry will reveal key features that influence adaptability.

Being tested
Nitrate enriched beetroot juice, Nitrate depleted beetroot juice, 12 week of combined exercise training

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Nitrate enriched beetroot juiceDietary supplement

    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.

  • Nitrate depleted beetroot juiceDietary supplement

    Manufacturer-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 trainingOther

    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.

Study groups in NCT07572266
Study groupRoleWhat they receive
Nitrate GroupExperimentalParticipants 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.
Receives: Dietary Supplement: Nitrate enriched beetroot juice; Other: 12 week of combined exercise training
Placebo GroupPlacebo 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.
Receives: Dietary Supplement: Nitrate depleted beetroot juice; Other: 12 week of combined exercise training

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 12 weeks

Secondary outcomes (6)
  1. Cardiorespiratory demand during submaximal cycle exercise.

    Supportive analyses will include secondary (cardiorespiratory demand during submaximal steady state exercise) outcomes. The steady state exercise cycling will be 10 minutes at 60% of peak power (Watts) during the VO2 peak test.

    Measured: 12 weeks

  2. Neuromuscular fatiguability during isometric holds.

    The knee extensors will perform a 30 second isometric flexion on a dynamometer. The fatigue will be defined by the force decline across the 30 seconds.

    Measured: 12 weeks

  3. 10 meter max gait speed.

    Participants will walk as quickly as possible across a 10 meter, straight course. Time is recorded for up to three attempts. A lower time indicates a faster speed.

    Measured: 12 weeks

  4. modified Balance Error Scoring System (mBESS)

    Stability is assessed with the Sway Medical tablet app via three stances: double-leg, single-leg, and tandem. Scoring is decided by losing balance or opening eyes during closed eyed tests.

    Measured: 12 weeks

  5. NIH PROMIS Physical Function SF

    The NIH PROMIS Physical Function Short Form (SF) is a standardized tool used to evaluate an individual's physical abilities and limitations in daily activities. It is part of the broader Patient-Reported Outcomes Measurement Information System (PROMIS), which focuses on measuring patient-reported outcomes across various health domains.

    Measured: 12 weeks

  6. NIH PROMIS Fatigue SF

    PROMIS Fatigue SF refers to the short form of the Patient-Reported Outcomes Measurement Information System designed to assess fatigue levels in patients. It provides a standardized way to measure fatigue, which can be used in various clinical settings to evaluate patient health status.

    Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 May 2026
  2. Study startNov 2026 (estimated)
  3. Primary completionMay 2031 (estimated)
  4. Study completionMay 2031 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Sequential
Model description
Parallel randomized controlled trials typically aim to test whether intervention "A" outperforms placebo "B" in group wise analyses based on a statistical analysis of variance comparing group means, where the mathematical probability of detecting "significance" between A and B increases with the degree of homogeneity of individual responses in group A and in group B. Our analytic plan in BOOST-X is far more innovative; it leverages the heterogeneity among individuals. After over two decades of studying potential mechanisms of Individual Response Heterogeneity (IRH) and strategies to boost response rates including exercise dosing, adjuvant nutrition, and adjuvant medication, the investigators have come to expect IRH. The goal is to maximize the proportion of individuals who attain clinically important health benefits, specifically MCIDs for CRF and fMQ. And the investigators hypothesize adjuvant nitrate will substantially boost this proportion.
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
226 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07572266
Sponsor's protocol ID
IRB-2026-0019
Acronym
BOOST-X
Status last verified
Apr 2026
First submitted
17 Apr 2026
Last updated
10 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

Questions about this trial

What is this clinical trial studying?

A study testing Nitrate enriched beetroot juice, Nitrate depleted beetroot juice and 12 week of combined exercise training in people with Aging and Aging Well, run by Florida Institute for Human and Machine Cognition at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 10 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Craig Tuggle, MA (850-202-4416, ctuggle@ihmc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the 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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2026.

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