NCT02921659

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Apr 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2015

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

September 29, 2016

Completed
2 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 3, 2016

Completed
Last Updated

December 1, 2016

Status Verified

November 1, 2016

Enrollment Period

1.5 years

First QC Date

September 29, 2016

Last Update Submit

November 29, 2016

Conditions

Aging

Keywords

nicotinamide ribosideagingarterial stiffnessendothelial dysfunction

Outcome Measures

Primary Outcomes (1)

  • Incidence of treatment emergent adverse events

    self reported side effects, vital signs, hematology, liver enzymes, markers of kidney function and blood chemistry

    6 weeks

Secondary Outcomes (5)

  • Endothelium Dependent Dilation

    6 weeks

  • Arterial Stiffness

    6 weeks

  • Cognitive Function

    6 weeks

  • Motor Function

    6 weeks

  • Systemic markers of oxidative stress and inflammation

    6 weeks

Study Arms (2)

Placebo

PLACEBO COMPARATOR

placebo, 500 mg, 2x/day for 6 weeks

Dietary Supplement: Placebo

Niagen™

ACTIVE COMPARATOR

Niagen™ (nicotinamide riboside chloride, ChromaDex, Inc.) 500mg, 2x/day for 6 weeks.

Dietary Supplement: Niagen™

Interventions

Niagen™DIETARY_SUPPLEMENT

nicotinamide riboside chloride, 250mg capsules

Also known as: Nicotinamide Riboside
Niagen™
PlaceboDIETARY_SUPPLEMENT

silicified microcrystalline cellulose, vegetarian capsule

Placebo

Eligibility Criteria

Age55 Years - 79 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Ability to provide informed consent
  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical Translational Research Center

Boulder, Colorado, 80309, United States

Location

Related Links

MeSH Terms

Interventions

nicotinamide-beta-riboside

Study Officials

  • Christopher R Martens, Ph.D.

    University of Colorado, Boulder

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 29, 2016

First Posted

October 3, 2016

Study Start

April 1, 2015

Primary Completion

October 1, 2016

Study Completion

October 1, 2016

Last Updated

December 1, 2016

Record last verified: 2016-11

Data Sharing

IPD Sharing
Will not share

Locations

US(1)