NRM on Vascular Perfusion in Healthy Adults (NRM)
The Effect of Oral Nicotinamide Riboside on Systemic Vascular Perfusion in Healthy Adults: A Critical Foundation of Cerebrovascular Health, Cardiovascular Health, and Healthy Aging
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Detailed Description
Study Type
Study Type
Enrollment (Estimated)
Enrollment
Phase
Phase
- Not Applicable
Contacts and Locations
Study Contact
Study Contact
- Name: Snigdha Panda, BS
- Phone Number: 507 538-5827
- Email: GIMResearchStudies@mayo.edu
Study Contact Backup
- Name: Jennifer Soderlind
- Phone Number: 507 284-4799
- Email: GIMResearchStudies@mayo.edu
Study Locations
-
-
Minnesota
-
Rochester, Minnesota, United States, 55905
- Mayo Clinic in Rochester
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- >= 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
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Active Comparator: 830 mg Nicotinamide and Placebo
830 mg Nicotinamide supplement capsule and 1 identical Placebo capsule twice a day for 12 weeks
|
Placebo
Active supplement.
Other Names:
|
|
Active Comparator: 1660 mg Nicotinamide
1660 mg Nicotinamide supplement; 2 of the 830 mg capsules twice a day for 12 weeks
|
Active supplement.
Other Names:
|
|
Placebo Comparator: Placebo
2 identical Placebo capsules twice a day for 12 weeks
|
Placebo
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of Participants with Reduced 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
Sponsor
Sponsor
Investigators
Investigators
- Principal Investigator: Ryan Hurt, MD, PhD, Mayo Clinic
- Principal Investigator: Brent Bauer, MD, Mayo Clinic
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Estimated)
Primary Completion
Study Completion (Estimated)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- 23-005288
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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.