Clinical trial

Nicotinamide Riboside as an Enhancer of Exercise Therapy in Hypertensive Older Adults (The NEET Trial)

Name
IRB201900746 -N-R
Description
More than 80% of older adults have hypertension, with higher prevalence of high systolic blood pressure (SBP) putting them at high risk for cardiovascular (CV) disease and death. Novel compound, nicotinamide riboside may enhance the effects of exercise therapy in hypertensive older adults.
Trial arms
Trial start
2020-07-28
Estimated PCD
2023-05-26
Trial end
2023-05-26
Status
Completed
Phase
Early phase I
Treatment
Walking Exercise
Participants randomized to this intervention 3 days/week of supervised, center-based walking exercise.
Arms:
NR plus Walking Exercise, Walking Exercise plus Placebo
Nicotinamide Riboside (NR)
Participants randomized to this intervention will receive 1,000 mg/day of NR.
Arms:
NR Alone, NR plus Walking Exercise
Size
147
Primary endpoint
Change in Daytime Systolic Blood Pressure
Baseline; Week 6
Eligibility criteria
Inclusion Criteria: * Age 55 years and older * Daytime average of systolic blood pressure of ≥ 130 mmHg and \< 160 mmHg. * Sedentary lifestyle, defined as \< 150 min/wk of moderate physical activity as assessed by the CHAMPS questionnaire. * Willingness to be randomized to either treatment group * Willingness to participate in all study procedures Exclusion Criteria: * Failure to provide informed consent. * Pregnant * Change in blood pressure therapy (type or dose) within the last 3 months- Temporary Exclusion * Daytime average of systolic blood pressure ≥160 mmHg. * Regular consumption of nicotinamide riboside supplement * Current involvement in supervised rehabilitation program * Absolute contraindication(s) to exercise training according to American College of Sports Medicine guidelines \[11\] * Daytime average of systolic blood pressure below 130mm Hg or Diastolic BP ≥ 100mm Hg. * Peripheral vascular disease; peripheral neuropathy; retinopathy * Severe cardiac disease, including NYHA Class III or IV congestive heart failure, clinically significant aortic stenosis, history of cardiac arrest, use of a cardiac defibrillator, or uncontrolled angina; * Myocardial infarction or stroke within past year * Significant cognitive impairment, including known dementia diagnosis or a Mini-Mental State Examination exam score \< 24 * Progressive, degenerative neurologic disease, e.g., Parkinson's Disease, multiple sclerosis; * Severe rheumatologic or orthopedic diseases, e.g., awaiting joint replacement, active inflammatory disease; * Severe pulmonary disease, requiring steroid therapy or the use of supplemental oxygen; * Hip fracture, hip or knee replacement, or spinal surgery within past 4 months; * Other significant co-morbid conditions that would impair ability to participate in the exercise-based intervention * Simultaneous participation in another intervention trial
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 147, 'type': 'ACTUAL'}}
Updated at
2024-06-06

1 organization

1 product

1 indication

Indication
Hypertension