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.
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)
- Type of treatment
- Lifestyle or therapy programme
- 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.
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 group | Role | What they receive |
|---|---|---|
| NR plus Walking Exercise | Active comparator | 1,000 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 Placebo | Active comparator | 1,000 mg/day of Placebo combined with three days/week of supervised, center-based walking exercise (n=18) Receives: Behavioral: Walking Exercise |
| NR Alone | Active comparator | 1,000 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.
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)
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.
- First posted2 Oct 2019
- Study start28 Jul 2020
- Primary completion26 May 2023
- Study completion26 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Robert Mankowski, PhD, Principal investigator, University of Florida
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
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nicotinamide Riboside as an Enhancer of Exercise Therapy in Hypertensive Older Adults (The NEET Trial)
- ClinicalTrials.gov ID
- NCT04112043
- Acronym / sponsor ID
- IRB201900746 -N-R
- Conditions
- Hypertension
- Keywords
- systolic blood pressure (SBP), cardiovascular (CV) disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 147 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 28 Jul 2020 (actual)
- Primary completion
- 26 May 2023 (actual)
- Study completion
- 26 May 2023 (actual)
- First posted
- 2 Oct 2019 (actual)
- Results
- Posted 6 Jun 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| NR plus Walking Exercise | Active comparator | Behavioral: Walking Exercise, Drug: Nicotinamide Riboside (NR)1,000 mg/day of NR combined with three days/week of supervised, center-based walking exercise (n=18) |
| Walking Exercise plus Placebo | Active comparator | Behavioral: Walking Exercise1,000 mg/day of Placebo combined with three days/week of supervised, center-based walking exercise (n=18) |
| NR Alone | Active comparator | Drug: Nicotinamide Riboside (NR)1,000 mg/day of NR |
Who may qualify
- Ages
- 55 to 105 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Walking ExerciseParticipants randomized to this intervention 3 days/week of supervised, center-based walking exercise. | Behavioural | NR plus Walking Exercise, Walking Exercise plus Placebo |
| Nicotinamide Riboside (NR)Participants randomized to this intervention will receive 1,000 mg/day of NR. | Drug | NR Alone, NR plus Walking Exercise |
Primary outcome
Change in Daytime Systolic Blood Pressure
Time frame: Baseline; Week 6
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.
1 secondary outcome
Change in Arterial Stiffness
Time frame: Baseline; Week 6
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert Mankowski, PhD principal investigator
University of Florida
1 site in 1 country: see every site and its status.
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.