Safety & Efficacy of Nicotinamide Riboside Supplementation for Improving Physiological Function in Middle-Aged and Older Adults

Aging Clinical Trial

Official title:

Safety & Efficacy of Nicotinamide Riboside Supplementation for Improving Physiological Function in Middle-Aged and Older Adults

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02921659
• Other study ID #: 14-0475
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: September 29, 2016
• Last updated: November 29, 2016
• Start date: April 2015
• Est. completion date: October 2016

Study information

• Verified date: November 2016
• Source: University of Colorado, Boulder
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Data and Safety Monitoring Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: October 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 55 Years to 79 Years

Eligibility

Inclusion Criteria:

• Ability to provide informed consent

• Baseline brachial flow-mediated dilation (FMD) < 6%? (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).

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Aging

Intervention

Dietary Supplement:
• Niagen™
nicotinamide riboside chloride, 250mg capsules
• Placebo
silicified microcrystalline cellulose, vegetarian capsule

Locations

Country	Name	City	State
United States	Clinical Translational Research Center	Boulder	Colorado

Sponsors (2)

Lead Sponsor	Collaborator
University of Colorado, Boulder	ChromaDex, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of treatment emergent adverse events	self reported side effects, vital signs, hematology, liver enzymes, markers of kidney function and blood chemistry	6 weeks	No
Secondary	Endothelium Dependent Dilation	Brachial Artery Flow-Mediated Dilation (FMD)	6 weeks	No
Secondary	Arterial Stiffness	Aortic Pulse Wave Velocity (PWV)	6 weeks	No
Secondary	Cognitive Function	NIH Toolbox Cognitive Function Battery	6 weeks	No
Secondary	Motor Function	NIH Toolbox Motor Function Battery	6 weeks	No
Secondary	Systemic markers of oxidative stress and inflammation	Assessment of plasma C-reactive protein (CRP) and circulating and mononuclear cell-derived cytokine and antioxidant expression.	6 weeks	No

External Links

•   Description of Research Laboratory