Effects of Nicotinamide Riboside on Metabolism and Vascular Function

September 23, 2020 updated by: Rudy Valentine, Iowa State University
The purpose of this study is to determine the effects of Nicotinamide Riboside (NR) supplementation on metabolism and vascular function following high-fat meal. Differences between young (18-35) and older (60-75) adults will be determined.

Study Overview

Detailed Description

The purpose of this study is to determine the effects of 7 days of Nicotinamide Riboside (NR) or placebo supplementation on metabolism and vascular function following high-fat meal. Differences between young (18-35) and older (60-75) adults will be determined.

Study Type

Interventional

Enrollment (Actual)

16

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Iowa
      • Ames, Iowa, United States, 50011
        • Iowa State University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 73 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age 18 to 35 (young) and 60 to 75 (older)
  • Normo- or pre-hypertensive (blood pressure <140/90 mmHg)
  • Non-smokers
  • Able to give informed consent and participate in all laboratory visits

Exclusion Criteria:

  • Currently taking any medications that could interfere with cardiovascular or metabolic outcomes will be excluded from the study (e.g., beta-blockers)
  • Known metabolic (e.g. Type I or Type II diabetes, cardiovascular disease, etc.) or immunologic (e.g. HIV, cancer, autoimmune, etc.) diseases
  • Food allergies to egg, milk, soy or wheat
  • Women who are pregnant or planning to become pregnant during the course of the study,
  • Pacemaker or other implanted device
  • Unwilling to participate in the experimental protocol or blood draws will be excluded

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Nicotinamide Riboside Chloride (Niagen)
7 days of nicotinamide riboside supplementation (250 mg/d x 2/day).
250 mg capsules 2x/day for 7 days
Other Names:
  • Nicotinamide Riboside, Niagen
Placebo Comparator: Placebo
7 days of placebo supplementation (2/day)
2x/day for 7 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
NAD+
Time Frame: 7 days
Blood and peripheral blood mononuclear cell (PBMC) levels
7 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Vasodilatory responsiveness
Time Frame: 7 days
Post-Occlusion Reactive Hyperemia (PORH)
7 days
Lipdemia
Time Frame: 7 days
Fasting and postprandial
7 days
Oxidative stress and inflammation
Time Frame: 7 days
Plasma markers and expression in circulating PBMCs
7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Rudy Valentine, PhD, Iowa State University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2018

Primary Completion (Actual)

December 1, 2019

Study Completion (Actual)

December 1, 2019

Study Registration Dates

First Submitted

April 10, 2018

First Submitted That Met QC Criteria

April 10, 2018

First Posted (Actual)

April 18, 2018

Study Record Updates

Last Update Posted (Actual)

September 25, 2020

Last Update Submitted That Met QC Criteria

September 23, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

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