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Effects of Nicotinamide Riboside on Metabolism and Vascular Function

Primary Purpose

Aging, Lipemia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Nicotinamide riboside chloride (Niagen)
Placebo
Sponsored by
Iowa State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Aging focused on measuring postpandial, lipemia, microvascular

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Iowa State University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Nicotinamide Riboside Chloride (Niagen)

Placebo

Arm Description

7 days of nicotinamide riboside supplementation (250 mg/d x 2/day).

7 days of placebo supplementation (2/day)

Outcomes

Primary Outcome Measures

NAD+
Blood and peripheral blood mononuclear cell (PBMC) levels

Secondary Outcome Measures

Vasodilatory responsiveness
Post-Occlusion Reactive Hyperemia (PORH)
Lipdemia
Fasting and postprandial
Oxidative stress and inflammation
Plasma markers and expression in circulating PBMCs

Full Information

First Posted
April 10, 2018
Last Updated
September 23, 2020
Sponsor
Iowa State University
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1. Study Identification

Unique Protocol Identification Number
NCT03501433
Brief Title
Effects of Nicotinamide Riboside on Metabolism and Vascular Function
Official Title
Effects of Nicotinamide Riboside on Metabolism and Vascular Function
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
February 1, 2018 (Actual)
Primary Completion Date
December 1, 2019 (Actual)
Study Completion Date
December 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Iowa State University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aging, Lipemia
Keywords
postpandial, lipemia, microvascular

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Randomized, cross-over
Masking
ParticipantOutcomes Assessor
Masking Description
I single investigator will be responsible for blinding. All researchers involved in collection and evaluation of data will remain blinded to treatments.
Allocation
Randomized
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Nicotinamide Riboside Chloride (Niagen)
Arm Type
Experimental
Arm Description
7 days of nicotinamide riboside supplementation (250 mg/d x 2/day).
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
7 days of placebo supplementation (2/day)
Intervention Type
Dietary Supplement
Intervention Name(s)
Nicotinamide riboside chloride (Niagen)
Other Intervention Name(s)
Nicotinamide Riboside, Niagen
Intervention Description
250 mg capsules 2x/day for 7 days
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
2x/day for 7 days
Primary Outcome Measure Information:
Title
NAD+
Description
Blood and peripheral blood mononuclear cell (PBMC) levels
Time Frame
7 days
Secondary Outcome Measure Information:
Title
Vasodilatory responsiveness
Description
Post-Occlusion Reactive Hyperemia (PORH)
Time Frame
7 days
Title
Lipdemia
Description
Fasting and postprandial
Time Frame
7 days
Title
Oxidative stress and inflammation
Description
Plasma markers and expression in circulating PBMCs
Time Frame
7 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rudy Valentine, PhD
Organizational Affiliation
Iowa State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Iowa State University
City
Ames
State/Province
Iowa
ZIP/Postal Code
50011
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Effects of Nicotinamide Riboside on Metabolism and Vascular Function

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