Overview

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

Status:
Recruiting
Trial end date:
2022-05-31
Target enrollment:
0
Participant gender:
All
Summary
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.
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
University of Florida
Collaborator:
National Institute on Aging (NIA)
Treatments:
Niacin
Niacinamide
Nicotinic Acids
Criteria
Inclusion Criteria:

- Daytime average of systolic blood pressure of >130 mmHg and < 160 mmHg. We will
recruit participants without an active hypertension medication treatment.

- 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;

- 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

- 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 either steroid pills or injections 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