Clinical trial NCT02921659: Safety & Efficacy of Nicotinamide Riboside Supplementation for Improving Physiological Function in Middle-Aged and Older Adults
Official title: Safety & Efficacy of Nicotinamide Riboside Supplementation for Improving Physiological Function in Middle-Aged and Older Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Aging
Keywords: nicotinamide riboside
aging
arterial stiffness
endothelial dysfunction
Lead sponsor: University of Colorado, Boulder
Sponsor class: OTHER
Collaborators: name: ChromaDex, Inc.
First posted: 2016-10-03
Enrollment: 30
Sex: ALL
Minimum age (years): 55
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the efficacy of supplementation with the Nicotinamide Adenine Dinucleotide (NAD+) precursor compound, Nicotinamide Riboside (NR), for improving physiological function (vascular, motor, and cognitive) in healthy middle-aged and older adults.

Detailed description: Overall, the proposed research project has the long-term potential to influence clinical practice by establishing novel therapies for treating multiple domains of age-associated physiological dysfunction and thereby reducing the risk of clinical disease and disability.

Eligibility criteria: Inclusion Criteria:

* Ability to provide informed consent
* Baseline brachial flow-mediated dilation (FMD) \< 6%Δ (rationale: non-invasive screening to ensure exclusion of subjects with exceptionally high baseline endothelial function.
* Ability to perform motor and cognitive tests (e.g., can rise from a chair, walk for 2 min, climb 10 stairs)
* Women will be confirmed as postmenopausal (either natural or surgical) based on cessation of menses for \>1 year.

Exclusion Criteria:

* ages \<55 years or ≥80 years
* body mass index (BMI) \>40 kg/m2 (rationale: vascular function and blood pressure measurements can be inaccurate in severely obese subjects and these subjects may differ in many ways from normal weight, overweight or less obese subjects)
* not weight stable in the prior 3 months (\>2 kg weight change) or unwilling to remain weight stable throughout study (rationale: recent weight change or weight loss can influence vascular function)
* having unstable angina, acute myocardial infarction, coronary angioplasty, or aorto-coronary bypass surgery as defined by the occurrence of an event, symptom, surgery, or change in medication and/or dosage within 3 months prior to enrollment
* having thyroid disease that is not controlled by medications or \<3 month's use of a particular medication and/or dosage (rationale: uncontrolled thyroid diseases are associated with alterations in vascular function)
* having past or present alcohol dependence or abuse, as defined by the American Psychiatry Association, Diagnostic and Statistical Manual of Mental Disorders
* abnormal blood chemistries for renal and liver function (\>1 standard deviation outside the normal range)
* Moderate or severe peripheral artery disease (ankle-brachial index \<0.7).
* Insufficient health to participate in a VO2max test based on a physical examination and/or graded exercise test (this will be determined in accordance with stated contraindications for exercise testing provided by the American Heart Association).

Primary outcomes:
measure: Incidence of treatment emergent adverse events
timeFrame: 6 weeks
Secondary outcomes:
measure: Endothelium Dependent Dilation
timeFrame: 6 weeks
measure: Arterial Stiffness
timeFrame: 6 weeks
measure: Cognitive Function
timeFrame: 6 weeks
measure: Motor Function
timeFrame: 6 weeks
measure: Systemic markers of oxidative stress and inflammation
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Boulder
country: United States
facility: Clinical Translational Research Center
state: Colorado
Study officials:
affiliation: University of Colorado, Boulder
name: Christopher R Martens, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: