Use of 31P MRS to Assess Brain NAD+ in Healthy Current an... | NCT02721537

Studies
Use of 31P MRS to Assess Brain NAD+ in Healthy Current and Former Collegiate Athletes

NCT02721537

Sponsor

Mayo Clinic

Status

Completed

Last Update Posted

Aug 3, 2022Actual

Enrollment

30Actual

Phase

Not Applicable

Conditions

Concussion, Mild

Interventions

Nicotinamide Riboside
Matching 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

Aug 2022

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

Sep 2016

Primary Completion Date

Aug 2022Actual

Completion Date

Aug 2022Actual

First Submitted Date

Mar 24, 2016

First Submission Date that Met QC Criteria

Mar 24, 2016

First Posted Date

Mar 29, 2016Estimated

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

Aug 2, 2022

Last Update Posted Date

Aug 3, 2022Actual

Name	Class
University of Minnesota	OTHER
Thorne HealthTech, Inc	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

Can nicotinamide riboside (750 mg/day for 12 weeks) affect the levels of NAD+ in the brain as measured by 31P MRS?

Detailed Description

Healthy collegiate athletes (football, soccer, rugby, hockey, and volleyball) will take Nicotinamide Riboside (NR) or placebo twice daily for 84 days. Pre- and post-intervention evaluations include physical assessment, blood tests for safety and toxicity monitoring, blood tests for biomarkers, neurologic testing, quality of life questionnaires, and the 31P MRI exam.

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

30Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Arm A: Healthy Collegiate Athletes	Active Comparator	Healthy collegiate athletes will take active Nicotinamide Riboside	Dietary Supplement: Nicotinamide Riboside
Arm B: Healthy Collegiate Athletes	Placebo Comparator	Healthy collegiate athletes will take a matching placebo	Other: Matching placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Nicotinamide Riboside	Dietary Supplement	Three capsules, twice per day for 84 days	Arm A: Healthy Collegiate Athletes

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in brain NAD+ levels	As measured by 31P MRI	baseline, day 84

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Adult current and former (within 2 years) collegiate athletes (football, rugby, soccer, hockey, and volleyball)
Body mass index (estimated based on height and weight) from 23 to 37
Willing to provide informed consent, ingest test substance, and provide blood specimens
Willing to comply with study instructions and maintain current level of physical activity throughout the study

Exclusion Criteria:

History of loss of consciousness of more than 5 minutes
Contraindications to Magnetic Resonance Imaging (MRI), such as implanted medical devices, metal objects, or pacemakers
History of epilepsy
History of more than 3 concussions
History of headache preceding a concussion
History of depression preceding a concussion
History of developmental delays or Attention Deficit Hyperactivity Disorder (ADHD)
History of post-traumatic seizures
History of complex spine and/or skull trauma

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Brent A Bauer, MD	Mayo Clinic in Rochester, MN	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Minnesota Center for Magnetic Resonance Research		Minneapolis	Minnesota	55455	United States

Label	URL
Mayo Clinic Clinical Trials	View source

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D001924	Brain Concussion

Ancestor Terms

ID	Term
D000070642	Brain Injuries, Traumatic
D001930	Brain Injuries
D001927	Brain Diseases
D002493	Central Nervous System 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