NCT03501433

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2018

Typical duration for not_applicable

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

February 1, 2018

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 10, 2018

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 18, 2018

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

September 25, 2020

Status Verified

September 1, 2020

Enrollment Period

1.8 years

First QC Date

April 10, 2018

Last Update Submit

September 23, 2020

Conditions

Keywords

postpandiallipemiamicrovascular

Outcome Measures

Primary Outcomes (1)

  • NAD+

    Blood and peripheral blood mononuclear cell (PBMC) levels

    7 days

Secondary Outcomes (3)

  • Vasodilatory responsiveness

    7 days

  • Lipdemia

    7 days

  • Oxidative stress and inflammation

    7 days

Study Arms (2)

Nicotinamide Riboside Chloride (Niagen)

EXPERIMENTAL

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

Dietary Supplement: Nicotinamide riboside chloride (Niagen)

Placebo

PLACEBO COMPARATOR

7 days of placebo supplementation (2/day)

Dietary Supplement: Placebo

Interventions

250 mg capsules 2x/day for 7 days

Also known as: Nicotinamide Riboside, Niagen
Nicotinamide Riboside Chloride (Niagen)
PlaceboDIETARY_SUPPLEMENT

2x/day for 7 days

Placebo

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Iowa State University

Ames, Iowa, 50011, United States

Location

MeSH Terms

Conditions

Hyperlipidemias

Interventions

nicotinamide-beta-riboside

Condition Hierarchy (Ancestors)

DyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Rudy Valentine, PhD

    Iowa State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
I single investigator will be responsible for blinding. All researchers involved in collection and evaluation of data will remain blinded to treatments.
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Model Details: Randomized, cross-over
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

April 10, 2018

First Posted

April 18, 2018

Study Start

February 1, 2018

Primary Completion

December 1, 2019

Study Completion

December 1, 2019

Last Updated

September 25, 2020

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will not share

Locations