NRM on Vascular Perfusion in Heathy Adults

Vascular Stiffness Clinical Trial

— NRM  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06345443
• Other study ID #: 23-005288
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 15, 2024
• Est. completion date: May 31, 2026

Study information

• Verified date: March 2024
• Source: Mayo Clinic
• Contact: Snigdha Panda, BS
• Phone: 507 538-5827
• Email: GIMResearchStudies[@]mayo.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: May 31, 2026
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Vascular Stiffness

Intervention

Dietary Supplement:
• Nicotinamide Riboside Malate
Active supplement.

Other:
• Placebo
Placebo

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction of 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