NRM on Vascular Perfusion in Healthy Adults

Mayo Clinic

Status: Invitation-only

Conditions: Vascular Stiffness

Treatments: Dietary Supplement: Nicotinamide Riboside Malate; Other: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT06345443

23-005288

Details and patient eligibility

About

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

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 40 to 60 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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200 participants in 3 patient groups, including a placebo group

830 mg Nicotinamide and Placebo

Active Comparator group

Description:

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

Treatment:

Other: Placebo

Dietary Supplement: Nicotinamide Riboside Malate

1660 mg Nicotinamide

Active Comparator group

Description:

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

Treatment:

Dietary Supplement: Nicotinamide Riboside Malate

Placebo

Placebo Comparator group

Description:

2 identical Placebo capsules twice a day for 12 weeks

Treatment:

Other: Placebo