NRM on Vascular Perfusion in Healthy Adults

NCT ID: NCT06345443

Last Updated: 2025-04-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-11-25

Study Completion Date

2026-09-30

Brief Summary

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

Detailed Description

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This study is a randomized, double-blind, placebo-controlled, parallel-dose clinical trial. Participants will be randomly assigned to one of three groups. Study measurements will be completed at three timepoints and intervention taken daily throughout the subject's 12 weeks of participation.

Conditions

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Vascular Stiffness

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Investigators
The pharmacy will be responsible for randomization and dispensing appropriate randomized intervention.

Study Groups

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830 mg Nicotinamide and Placebo

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

Group Type ACTIVE_COMPARATOR

Nicotinamide Riboside Malate

Intervention Type DIETARY_SUPPLEMENT

Active supplement.

Placebo

Intervention Type OTHER

Placebo

1660 mg Nicotinamide

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

Group Type ACTIVE_COMPARATOR

Nicotinamide Riboside Malate

Intervention Type DIETARY_SUPPLEMENT

Active supplement.

Placebo

2 identical Placebo capsules twice a day for 12 weeks

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Placebo

Interventions

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Nicotinamide Riboside Malate

Active supplement.

Intervention Type DIETARY_SUPPLEMENT

Placebo

Placebo

Intervention Type OTHER

Other Intervention Names

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NRM

Eligibility Criteria

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Inclusion Criteria

* \>= 40 and \<=60
* 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

Exclusion Criteria

* Pregnant, nursing, or trying to conceive
* BMI Restrictions: \<30
* 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.
Minimum Eligible Age

40 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Ryan T. Hurt, M.D., Ph.D.

Principle Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ryan Hurt, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Brent Bauer, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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Mayo Clinic in Rochester

Rochester, Minnesota, United States

Site Status

Countries

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United States

Other Identifiers

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23-005288

Identifier Type: -

Identifier Source: org_study_id

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