NRM on Vascular Perfusion in Heathy Adults (NRM)

March 28, 2024 updated by: Ryan T. Hurt, M.D., Ph.D., Mayo Clinic

The Effect of Oral Nicotinamide Riboside on Systemic Vascular Perfusion in Heathy Adults: A Critical Foundation of Cerebrovascular Health, Cardiovascular Health, and Healthy Aging

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group A
830 mg Nicotinamide supplement capsule and 1 identical Placebo capsule twice a day for 12 weeks
Other: Placebo
Placebo
Dietary supplement: Nicotinamide Riboside Malate
Active supplement.
Other Names:
  • NRM
Active Comparator: Group B
1660 mg Nicotinamide supplement; 2 of the 830 mg capsules twice a day for 12 weeks
Dietary supplement: Nicotinamide Riboside Malate
Active supplement.
Other Names:
  • NRM
Placebo Comparator: Group C
2 identical Placebo capsules twice a day for 12 weeks
Other: Placebo
Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reduction of Endothelial stiffness
Time Frame: Baseline to End of study at 12 weeks
Endothelial Peripheral Arterial Tonometry testing will be used to assess endothelial stiffness changes over study
Baseline to End of study at 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Investigators

  • Principal Investigator: Brent Bauer, MD, Mayo Clinic
  • Principal Investigator: Ryan Hurt, MD, Mayo Clinic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 15, 2024

Primary Completion (Estimated)

December 31, 2025

Study Completion (Estimated)

May 31, 2026

Study Registration Dates

First Submitted

March 28, 2024

First Submitted That Met QC Criteria

March 28, 2024

First Posted (Actual)

April 3, 2024

Study Record Updates

Last Update Posted (Actual)

April 3, 2024

Last Update Submitted That Met QC Criteria

March 28, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 23-005288

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Vascular Stiffness

Clinical Trials on Placebo

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in France

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe