NRM on Vascular Perfusion in Healthy Adults

Not Applicable

• Conditions: Vascular Stiffness
• Interventions: Other: Placebo; Dietary Supplement: Nicotinamide Riboside Malate

• Registration Number: NCT06345443
• Lead Sponsor: Mayo Clinic

Brief Summary

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

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 Timeline

• Study First Submitted: 2024-03-28
• Study First Submitted QC: 2024-03-28
• Study First Posted: 2024-04-03
• Study Start: 2024-11-25
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-18
• Last Update Posted: 2025-04-23
• Primary Completion: 2026-02-28
• Study Completion: 2026-09-30

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 200

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	2 identical Placebo capsules twice a day for 12 weeks
830 mg Nicotinamide and Placebo	Placebo	830 mg Nicotinamide supplement capsule and 1 identical Placebo capsule twice a day for 12 weeks
1660 mg Nicotinamide	Nicotinamide Riboside Malate	1660 mg Nicotinamide supplement; 2 of the 830 mg capsules twice a day for 12 weeks
830 mg Nicotinamide and Placebo	Nicotinamide Riboside Malate	830 mg Nicotinamide supplement capsule and 1 identical Placebo capsule twice a day for 12 weeks

Primary Outcome Measures

Name	Time	Method
Number of Participants with Reduced Endothelial Stiffness	Baseline to End of study at 12 weeks	Endothelial Peripheral Arterial Tonometry testing will be used to assess endothelial stiffness changes over study

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States