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Effects of Nicotinamide Riboside on Metabolism and Vascular Function

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ClinicalTrials.gov Identifier: NCT03501433
Recruitment Status : Recruiting
First Posted : April 18, 2018
Last Update Posted : April 18, 2018
Sponsor:
Information provided by (Responsible Party):
Rudy Valentine, Iowa State University

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.

Condition or disease Intervention/treatment Phase
Aging Lipemia Dietary Supplement: Nicotinamide riboside chloride (Niagen) Dietary Supplement: Placebo Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Randomized, cross-over
Masking: Double (Participant, Outcomes 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.
Primary Purpose: Basic Science
Official Title: Effects of Nicotinamide Riboside on Metabolism and Vascular Function
Actual Study Start Date : February 1, 2018
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Nicotinamide Riboside Chloride (Niagen)
7 days of nicotinamide riboside supplementation (250 mg/d x 2/day).
Dietary Supplement: Nicotinamide riboside chloride (Niagen)
250 mg capsules 2x/day for 7 days
Other Name: Nicotinamide Riboside, Niagen

Placebo Comparator: Placebo
7 days of placebo supplementation (2/day)
Dietary Supplement: Placebo
2x/day for 7 days




Primary Outcome Measures :
  1. NAD+ [ Time Frame: 7 days ]
    Blood and peripheral blood mononuclear cell (PBMC) levels


Secondary Outcome Measures :
  1. Vasodilatory responsiveness [ Time Frame: 7 days ]
    Post-Occlusion Reactive Hyperemia (PORH)

  2. Lipdemia [ Time Frame: 7 days ]
    Fasting and postprandial

  3. Oxidative stress and inflammation [ Time Frame: 7 days ]
    Plasma markers and expression in circulating PBMCs



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03501433


Contacts
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Contact: Rudy Valentine, PhD 515-294-3867 rvalenti@iastate.edu

Locations
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United States, Iowa
Iowa State University Recruiting
Ames, Iowa, United States, 50011
Contact: Rudy Valentine, Ph.D.    515-294-3867    rvalenti@iastate.edu   
Principal Investigator: Rudy Valentine, Ph.D.         
Sponsors and Collaborators
Iowa State University
Investigators
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Principal Investigator: Rudy Valentine, PhD Iowa State University

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Responsible Party: Rudy Valentine, Assistant Professor, Iowa State University
ClinicalTrials.gov Identifier: NCT03501433     History of Changes
Other Study ID Numbers: 17-603
First Posted: April 18, 2018    Key Record Dates
Last Update Posted: April 18, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Rudy Valentine, Iowa State University:
postpandial
lipemia
microvascular
Additional relevant MeSH terms:
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Niacinamide
Niacin
Nicotinic Acids
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Vitamin B Complex
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Vasodilator Agents