NCT06345443

Brief Summary

The purpose of this study is to better understand the effects of nicotinamide riboside supplement in overall cardiovascular health in healthy adults.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
8mo left

Started Nov 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress69%
Nov 2024Dec 2026

First Submitted

Initial submission to the registry

March 28, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 3, 2024

Completed
8 months until next milestone

Study Start

First participant enrolled

November 25, 2024

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2026

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

March 18, 2026

Status Verified

March 1, 2026

Enrollment Period

1.8 years

First QC Date

March 28, 2024

Last Update Submit

March 16, 2026

Conditions

Vascular Stiffness

Keywords

cardiovascularNicotinamide RibosideSupplementsNRM

Outcome Measures

Primary Outcomes (1)

  • Number of Participants with Reduced Endothelial Stiffness

    Endothelial Peripheral Arterial Tonometry testing will be used to assess endothelial stiffness changes over study

    Baseline to End of study at 12 weeks

Study Arms (3)

830 mg Nicotinamide and Placebo

ACTIVE COMPARATOR

830 mg Nicotinamide supplement capsule and 1 identical Placebo capsule twice a day for 12 weeks

Dietary Supplement: Nicotinamide Riboside MalateOther: Placebo

1660 mg Nicotinamide

ACTIVE COMPARATOR

1660 mg Nicotinamide supplement; 2 of the 830 mg capsules twice a day for 12 weeks

Dietary Supplement: Nicotinamide Riboside Malate

Placebo

PLACEBO COMPARATOR

2 identical Placebo capsules twice a day for 12 weeks

Other: Placebo

Interventions

Nicotinamide Riboside MalateDIETARY_SUPPLEMENT

Active supplement.

Also known as: NRM
1660 mg Nicotinamide830 mg Nicotinamide and Placebo
PlaceboOTHER

Placebo

830 mg Nicotinamide and PlaceboPlacebo

Eligibility Criteria

Age35 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \>= 35 and \<=70
  • Provides consent to participate in the study
  • Not pregnant at time of consent
  • Understands and agrees to follow all study procedures and limitations
  • Have no contraindicating comorbid health condition as determined by the clinical investigators

You may not qualify if:

  • Pregnant, nursing, or trying to conceive
  • BMI Restrictions: \<35
  • Allergy or sensitivity to study agent ingredients
  • Hypertension treated with medication
  • Use of natural health products containing nicotinamide riboside, quercetin, trans-resveratrol, or betaine anhydrous within 7 days prior to randomization and during the course of the study.
  • Surgery planned during the course of the trial
  • History or past diagnosis of chronic diseases, unstable medical conditions, blood/bleeding disorders or stroke
  • History or current diagnosis of cancer (except for successfully treated basal cell carcinoma diagnosed less than 5 years prior to screening or cancer in full remission more than 5 years after diagnosis.
  • Abnormal blood chemistries for renal or liver function (defined as 1 standard deviation outside of the normal range), alcohol dependence, uncontrolled thyroid disease, severe obesity (body mass index \>40 kg m-2), or weight stable for at least 3 months prior to enrolling in the study (defined as \>2 kg change in body mass).
  • An unstable medical or mental health condition as determined by the physician investigator.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Study Officials

  • Ryan Hurt, MD, PhD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

  • Brent Bauer, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Masking Details
The pharmacy will be responsible for randomization and dispensing appropriate randomized intervention.
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator

Study Record Dates

First Submitted

March 28, 2024

First Posted

April 3, 2024

Study Start

November 25, 2024

Primary Completion (Estimated)

September 30, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

March 18, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)