Adjuvant Nitrate to Boost Exercise-induced Health Benefits in Older Adults
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age60+
SponsorFlorida Institute for Human and Machine Cognition
About this trial
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
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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.
Trial design
Design model
Sequential
Treatments tested in this trial
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
Other interventionAll 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.
Treatment groups
226 Participants
are divided into 2 treatment groupsGroup A: Nitrate GroupExperimental treatment 2 interventions
Group B: Placebo GroupPlacebo comparator 2 interventions
Trial outcomes
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.
Time frame
12 weeksSecondary outcomes
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.
Time frame
12 weeks2
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.
Time frame
12 weeks3
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.
Time frame
12 weeks4
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.
Time frame
12 weeksOther outcomes
1
Cognitive function.
Cognitive function is assessed via Sway Medical reaction time via three assessments: visual processing speed: measures how quickly a person can interpret visual information.
Time frame
12 weeks2
Psychological state.
Depression and anxiety are assessed via the well-validated Patient Health Questionnaire 9 (PHQ-9) both via Sway. The PHQ-9, or Patient Health Questionnaire-9, is a tool used to screen for, diagnose, and measure the severity of depression. It consists of nine questions that assess how often a person has experienced symptoms of depression over the past two weeks.
Time frame
12 weeks3
Sleep quality and nocturnal stress.
Perceptions of sleep quality are measured using the short forms (SF) of PROMIS Sleep Disturbance and Sleep-Related Impairment. For direct monitoring, participants wear an Oura Gen-4 ring to quantify sleep behavior with stress monitored via Heart Rate /Heart Rate variability (HRV) across the full enrollment period, as we have done in previous studies including the ongoing NIA M3AX Trial (NCT06507189). The Oura ring is well validated against polysomnography for several sleep metrics and nocturnal HR/HRV.
Time frame
12 weeks4
Free-living activity via the Oura Gen 4.
Free-living activity is also monitored daily via the Oura Gen-4 ring worn throughout trial participation. Variables such as step count and heart rate will used to determine activity.
Time frame
12 weeksSponsors and contacts
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Source ClinicalTrials.gov
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