NCT07475208

Brief Summary

Hypertension continues to pose a significant global health challenge, with rates of optimal blood pressure control remaining low - particularly in China, where fewer than 5% of individuals with hypertension achieve guideline-recommended targets. Age-associated endothelial dysfunction and arterial stiffness are recognized as the key contributors to the development of hypertension and the unique role of nicotinamide adenine dinucleotide (NAD) depletion in the pathogenesis of vascular dysfunction has been recently discovered. Treatment with nicotinamide riboside (NR), an NAD precursor, has shown promise in preliminary clinical trials for improving blood pressure and vascular health in at-risk populations. In parallel, aerobic exercise is a well-established non-pharmacologic intervention known to improve cardiovascular outcomes. Emerging studies suggest that exercise may modulate NAD biosynthesis pathways, pointing toward a synergistic potential when combined with NAD-boosting strategies. However, clinical data evaluating the combined effects of NR supplementation and aerobic exercise remain scarce. Our randomized, placebo-controlled, four-arm, parallel-group design seeks to address this gap. The investigators will investigate the independent and combined effects of 10-week NR supplementation and brisk walking on blood pressure and vascular health in post-menopausal women with elevated/stage I hypertension. This population is specifically targeted due to their heightened risk for vascular dysfunction post-menopause and the observed responsiveness to NR-based interventions in prior studies. The investigators believe the findings from this trial will provide insight into the feasibility, safety, and efficacy of combining NAD-boosting supplementation with structured exercise in a uniquely vulnerable and previously understudied population. The potential to identify a low-risk, non-pharmaceutical therapeutic approach holds strong implications for public health, particularly in aging women with early-stage hypertension.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
112

participants targeted

Target at P50-P75 for not_applicable

Timeline
18mo left

Started Apr 2026

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress9%
Apr 2026Dec 2027

First Submitted

Initial submission to the registry

March 12, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 16, 2026

Completed
16 days until next milestone

Study Start

First participant enrolled

April 1, 2026

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

March 18, 2026

Status Verified

March 1, 2026

Enrollment Period

8 months

First QC Date

March 12, 2026

Last Update Submit

March 16, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Blood pressure

    Blood pressure will be measured using an automated sphygmomanometer that meets the standards from the Association for the Advancement of Medical Instrumentation and the European Society for Hypertension and following standardized procedures. Two measurements will be taken after 5 min sitting rest in a quiet room with comfortable temperature. During assessments, participants will be seated with their back supported, feet flat on the floor, legs uncrossed, and their arm resting on a table with the midpoint of the upper arm aligned at heart level. Two readings of systolic and diastolic blood pressures will be obtained, spaced 2 minutes apart, and the average of the two measurements will be recorded as the final blood pressure reading. If the difference between the two measurements exceeds 5 mmHg, an additional reading will be taken, and the average of all three readings will be used as the final measurement.

    From enrollment to the end of follow-up at 20 weeks

Secondary Outcomes (13)

  • Whole Blood NAD concentration

    From enrollment to the end of follow-up at 20 weeks

  • Endothelin 1

    From enrollment to the end of follow-up at 20 weeks

  • Angiotensin

    From enrollment to the end of follow-up at 20 weeks

  • Body mass

    From enrollment to the end of follow-up at 20 weeks

  • Fat mass

    From enrollment to the end of follow-up at 20 weeks

  • +8 more secondary outcomes

Other Outcomes (6)

  • Food diary

    From enrollment to the end of follow-up at 20 weeks

  • Medication usage

    From enrollment to the end of follow-up at 20 weeks

  • International Physical Activity Questionnaire (IPAQ)

    From enrollment to the end of follow-up at 20 weeks

  • +3 more other outcomes

Study Arms (4)

NR + BW

EXPERIMENTAL

NR supplementation plus brisk walking

Behavioral: Brisk walkingDietary Supplement: Nicotinamide Riboside 1000 mg

PL + BW

PLACEBO COMPARATOR

Placebo plus brisk walking

Behavioral: Brisk walkingOther: Placebo

NR

ACTIVE COMPARATOR

NR supplementation only

Dietary Supplement: Nicotinamide Riboside 1000 mg

PL

PLACEBO COMPARATOR

Placebo only

Other: Placebo

Interventions

Brisk walkingBEHAVIORAL

Brisk walking twice per week

NR + BWPL + BW

Nicotinamide Riboside supplementation 1000 mg per day

NRNR + BW
PlaceboOTHER

Placebo

PLPL + BW

Eligibility Criteria

Age55 Years - 80 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • women absent of menstruation for over one year,
  • Chinese, and
  • fulfill the criteria of elevated/stage I hypertension according to 2025 American College of Cardiology/American Heart Association Guideline for the Prevention, Detection, Evaluation, and Management of High Blood Pressure in Adults (i.e., blood pressure ≥120/80 mmHg based on an average of ≥2 readings obtained on ≥2 occasions)

You may not qualify if:

  • presence of health conditions that contraindicate participation in exercise training, such as a history of cardiovascular disease, cancer, or musculoskeletal disorders,
  • a history of hysterectomy,
  • current use of vitamin B supplements and/or NAD precursors,
  • ongoing hormone replacement therapy within the past six months,
  • any changes in antihypertensive medication type or dosage within the last three months, or
  • engagement in regular physical activity, defined as at least 150 minutes of moderate-intensity exercise or 75 minutes of vigorous-intensity exercise per week, during the three months prior to enrollment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Hypertension

Interventions

nicotinamide-beta-riboside

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 12, 2026

First Posted

March 16, 2026

Study Start

April 1, 2026

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2027

Last Updated

March 18, 2026

Record last verified: 2026-03