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HypertensionPhase 1NCT04112043

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

A Phase 1 study testing Walking Exercise and Nicotinamide Riboside (NR) in people with Hypertension, run by University of Florida at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 55 to 105 years
Conditions the study is for
Hypertension
What is being tested?
Walking Exercise and Nicotinamide Riboside (NR)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
147 participants
Where
1 siteUnited States
Study dates
28 Jul 2020to 26 May 2023
Phase
Phase 1
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 55 to 105 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 18Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • UF Institute on Aging

    Gainesville, Florida, 32611

Other trials in United States

About this study

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.

Read the detailed description

More than 80% of older adults have hypertension, with a higher prevalence of high systolic blood pressure (SBP) putting them at high risk for cardiovascular (CV) disease and death. Because drug therapy that lowers SBP is associated with side effects such as hypotension, syncope, and kidney dysfunction, there is a great need for effective lifestyle SBP-lowering interventions for the older population that can replace drug therapy. While aerobic exercise is a recommended lifestyle intervention for controlling SBP and preventing CV disease naturally, in older adults it has been shown to be less effective in vascular-tissue remodeling because of arterial stiffness, resulting in less efficient SBP control. Reduced bioavailability of nicotinamide adenine dinucleotide (NAD+), a cofactor for the deacetylase sirtuin1 (SIRT1), may contribute to age-related vascular dysfunction via oxidative stress and reduced nitric oxide (NO). Exercise-induced overexpression of NAD+-dependent SIRT1 improves the bioavailability of NO. Preclinical evidence suggests that poor vascular function improvement in response to exercise in older mice is caused by insufficient NAD+ levels to stimulate SIRT1 activity. Importantly, replenishment of NAD+ levels induced vascular remodeling, improved vascular function, and reduced SBP in mice. An objective of this study, therefore, is to test a combination of aerobic exercise and nicotinamide riboside, a compound that replenishes NAD+ levels, to optimize exercise's SBP-lowering effect in hypertensive older adults. Initial human clinical trials demonstrated that nicotinamide riboside supplementation (1,000 mg/day) was safe and showed a higher potential to reduce SBP and arterial stiffness in participants with elevated SBP. As we have preclinical evidence that combining NAD+ replenishment with exercise is an ideal strategy for improving vascular function, our central hypothesis is that the intervention of aerobic-exercise training combined with nicotinamide riboside supplementation will reduce SBP in hypertensive older adults more effectively than will exercise alone. We will enroll 54 participants ≥ 55 years and older into either: (1) 1,000 mg/day of nicotinamide riboside plus 3 days/week of supervised, center-based walking exercise (n=18), or (2) the same exercise program combined with placebo (n=18), or (3) 1,000 mg/day of nicotinamide riboside alone (n=18). All participants will undergo daytime continuous SBP at baseline, 3 weeks, and 6 weeks, and arterial-stiffness measurements by pulse-wave velocity at baseline and at 6 weeks. Elevated SBP will be determined as daytime average equal to or above 130 mmHg, measured by the 24-hour blood-pressure device. To our knowledge, this study will be the first attempt to enhance exercise therapy with nicotinamide riboside in hypertensive older adults. We believe that nicotinamide riboside is "the missing piece of the puzzle" in improving vascular remodeling and SBP management in older adults. Preliminary evidence from this pilot study may support a full-scale Phase III clinical trial in hypertensive older adults. The ultimate goal of this line of research is to find adjuvant strategies to improve the exercise's SBP-lowering effects in older adults.

Conditions
Hypertension
Being tested
Walking Exercise, Nicotinamide Riboside (NR)
Keywords
systolic blood pressure (SBP), cardiovascular (CV) disease
Medical subject headings
Hypertension, Disease

What participants receive

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

  • Walking ExerciseBehavioural

    Participants randomized to this intervention 3 days/week of supervised, center-based walking exercise.

  • Nicotinamide Riboside (NR)Drug

    Participants randomized to this intervention will receive 1,000 mg/day of NR.

Study groups in NCT04112043
Study groupRoleWhat they receive
NR plus Walking ExerciseActive comparator1,000 mg/day of NR combined with three days/week of supervised, center-based walking exercise (n=18)
Receives: Behavioral: Walking Exercise; Drug: Nicotinamide Riboside (NR)
Walking Exercise plus PlaceboActive comparator1,000 mg/day of Placebo combined with three days/week of supervised, center-based walking exercise (n=18)
Receives: Behavioral: Walking Exercise
NR AloneActive comparator1,000 mg/day of NR
Receives: Drug: Nicotinamide Riboside (NR)

What is being measured

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

  1. Change in Daytime Systolic Blood Pressure

    The primary outcome of this study is the change in average daytime systolic blood pressure. Systolic blood pressure was measured every 20 minutes (min) during the day (from 0700 to 2200 hours) at baseline and week 6 visits. Based on the American Heart Association guideline, we selected twenty valid daytime blood pressure recordings to calculate the average daytime value, then we calculated the mean differences between week 6 and baseline.

    Measured: Baseline; Week 6

Secondary outcomes (1)
  1. Change in Arterial Stiffness

    The measurement of aortic pulse-wave velocity (PWV), particularly between the carotid and femoral arteries (cfPWV), was conducted using the SphygmoCor XCEL system. Briefly, cfPWV was determined by recording pressure pulse waves at the carotid and femoral arteries using a high-fidelity micromanometer and calculating the distance between the recording sites divided by the time delay between the carotid and the femoral pulse waves.

    Measured: Baseline; Week 6

Timeline

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

  1. First posted2 Oct 2019
  2. Study start28 Jul 2020
  3. Primary completion26 May 2023
  4. Study completion26 May 2023

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 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
147 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04112043
Sponsor's protocol ID
IRB201900746 -N-R
Other IDs
OCR26682, 5R21AG064282, AWD06755
Status last verified
May 2024
First submitted
27 Sep 2019
Last updated
6 Jun 2024
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Walking Exercise and Nicotinamide Riboside (NR) in people with Hypertension, run by University of Florida 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 5 inclusion and 18 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: finished, as of the sponsor's last update on 6 Jun 2024. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 Jun 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Daytime Systolic Blood Pressure (time frame: Baseline; Week 6). 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 6 Jun 2024.

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