Effects of Nicotinamide Riboside on Metabolism and Vascul... | NCT03501433

Studies
Effects of Nicotinamide Riboside on Metabolism and Vascular Function

NCT03501433

Sponsor

Iowa State University

Status

Completed

Last Update Posted

Sep 25, 2020Actual

Enrollment

16Actual

Phase

Not Applicable

Conditions

Aging
Lipemia

Interventions

Nicotinamide riboside chloride (Niagen)
Placebo

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 1, 2018Actual

Primary Completion Date

Dec 1, 2019Actual

Completion Date

Dec 1, 2019Actual

First Submitted Date

Apr 10, 2018

First Submission Date that Met QC Criteria

Apr 10, 2018

First Posted Date

Apr 18, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 23, 2020

Last Update Posted Date

Sep 25, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

16Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Nicotinamide riboside chloride (Niagen)	Dietary Supplement	250 mg capsules 2x/day for 7 days	Nicotinamide Riboside Chloride (Niagen)

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Vasodilatory responsiveness	Post-Occlusion Reactive Hyperemia (PORH)	7 days
Lipdemia	Fasting and postprandial	7 days

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Rudy Valentine, PhD	Iowa State University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Iowa State University		Ames	Iowa	50011	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D006949	Hyperlipidemias

Ancestor Terms

ID	Term
D050171	Dyslipidemias
D052439	Lipid Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C018613	nicotinamide-beta-riboside

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided

Masking Info

Masking

Double

Masking Description

I single investigator will be responsible for blinding. All researchers involved in collection and evaluation of data will remain blinded to treatments.

Who Masked

ParticipantOutcomes Assessor