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

NCT04112043 | Completed Phase 1 Results DMC FDA Drug

• 4 other identifiers: IRB201900746 -N-ROCR266825R21AG064282AWD06755
• Study Type: interventional
• Target: 147
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hypertension

Keywords

systolic blood pressure (SBP); cardiovascular (CV) disease

Outcome Measures

Primary Outcomes (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.

  Baseline; Week 6

Secondary Outcomes (1)

• Change in Arterial Stiffness

  Baseline; Week 6

Study Arms (3)

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)

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)

Behavioral: Walking Exercise

NR Alone

ACTIVE COMPARATOR

1,000 mg/day of NR

Drug: Nicotinamide Riboside (NR)

Interventions

Walking Exercise BEHAVIORAL

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

NR plus Walking Exercise; Walking Exercise plus Placebo

Nicotinamide Riboside (NR) DRUG

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

NR Alone; NR plus Walking Exercise

Eligibility Criteria

• Age: 55 Years - 105 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Failure to provide informed consent.
• Pregnant
• 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;

Sponsors & Collaborators

• University of Florida: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

UF Institute on Aging

Gainesville, Florida, 32611, United States

Location

MeSH Terms

Conditions

Hypertension; Disease

Interventions

nicotinamide-beta-riboside

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr. Robert Mankowski
• Organization: University of Florida

r.mankowski@ufl.edu

352-294-5055

Study Officials

• Robert Mankowski, PhD

  University of Florida

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 27, 2019
• First Posted: October 2, 2019
• Study Start: July 28, 2020
• Primary Completion: May 26, 2023
• Study Completion: May 26, 2023
• Last Updated: June 6, 2024
• Results First Posted: June 6, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)