- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03501433
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
Status
Completed
Intervention / Treatment
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:
|
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.
Sponsor
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
Keywords
Additional Relevant MeSH Terms
- Metabolic Diseases
- Lipid Metabolism Disorders
- Dyslipidemias
- Hyperlipidemias
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Vasodilator Agents
- Antimetabolites
- Micronutrients
- Hypolipidemic Agents
- Lipid Regulating Agents
- Vitamins
- Vitamin B Complex
- Nicotinic Acids
- Niacinamide
- Niacin
Other Study ID Numbers
- 17-603
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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