NCT03151239

Brief Summary

The purpose of the study is to understand the effect of the dietary supplement "Nicotinamide mononucleotide" on metabolic health in people.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2017

Longer than P75 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

First Submitted

Initial submission to the registry

May 8, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 12, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

July 1, 2017

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2019

Completed
2.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2021

Completed
Last Updated

July 14, 2021

Status Verified

July 1, 2021

Enrollment Period

1.9 years

First QC Date

May 8, 2017

Last Update Submit

July 13, 2021

Conditions

Glucose Metabolism Disorders

Outcome Measures

Primary Outcomes (1)

  • Change in muscle insulin sensitivity

    The outcome will be assessed by hyperinsulinemic-euglycemic clamp procedure in conjunction with stable isotopic tracer infusion before and after intervention period.

    before and after at least 8 weeks of treatment

Secondary Outcomes (12)

  • Changes in liver insulin sensitivity

    before and after at least 8 weeks of treatment

  • Change in adipose tissue insulin sensitivity

    before and after at least 8 weeks of treatment

  • Change in body fat mass

    before and after at least 8 weeks of treatment

  • Change in fat free mass

    before and after at least 8 weeks of treatment

  • Changes in intra-abdominal adipose tissue volume

    before and after at least 8 weeks of treatment

  • +7 more secondary outcomes

Study Arms (2)

Placebo

PLACEBO COMPARATOR
Other: Placebo

NMN supplementation

EXPERIMENTAL
Dietary Supplement: NMN supplement

Interventions

NMN supplementDIETARY_SUPPLEMENT

Intervention will last at least 8 weeks in the form of two capsules (250 mg total).

Also known as: nicotinamide mononucleotide
NMN supplementation
PlaceboOTHER

Intervention will last at least 8 weeks in the form of two capsules.

Placebo

Eligibility Criteria

Age55 Years - 75 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Postmenopausal women 55-75 years old
  • BMI 25.0-44.9 kg/m²
  • Fasting plasma glucose concentration ≥100 mg/dl, OGTT 2 hour glucose ≥ 140 mg/dl, HbA1C ≥5.7%, or HOMA-IR ≥2.5

You may not qualify if:

  • Diabetes
  • Premenopausal or menopause \<1 year
  • Persons who have received hormone replacement therapy within the past 6 months
  • Persons who take vitamin B supplementation and are not willing to discontinue supplementation for 3 weeks before and during the entire study period.
  • Structured exercise: ≥75 min/wk of vigorous exercise (e.g., jogging, activity that causes heavy breathing and sweating) or ≥150 min/wk of low intensity physical activity (e.g., brisk walking).
  • Unstable weight (\>3% change during the last 2 months before entering the study)
  • Significant organ system dysfunction or disease
  • Present cancer or history of cancer that has been in remission for \<5 years
  • Polycystic ovary syndrome
  • Major psychiatric illness
  • Use of medications known to affect study outcome measures (e.g., steroid) or increase the risk of study procedures (e.g., anticoagulants) that cannot be temporarily discontinued for the study
  • Metal implants
  • Smokes cigarettes
  • Persons who consume \>14 units of alcohol per week
  • Unable or unwilling to follow the study protocol or who, for any reason, is considered an inappropriate candidate for the study by the research team.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Related Publications (1)

  • Yoshino M, Yoshino J, Kayser BD, Patti GJ, Franczyk MP, Mills KF, Sindelar M, Pietka T, Patterson BW, Imai SI, Klein S. Nicotinamide mononucleotide increases muscle insulin sensitivity in prediabetic women. Science. 2021 Jun 11;372(6547):1224-1229. doi: 10.1126/science.abe9985. Epub 2021 Apr 22.

    PMID: 33888596DERIVED

MeSH Terms

Conditions

Glucose Metabolism Disorders

Interventions

Nicotinamide Mononucleotide

Condition Hierarchy (Ancestors)

Metabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

RibonucleotidesNucleotidesNucleic Acids, Nucleotides, and Nucleosides

Study Officials

  • Samuel Klein, MD

    Washington University School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 8, 2017

First Posted

May 12, 2017

Study Start

July 1, 2017

Primary Completion

May 30, 2019

Study Completion

June 30, 2021

Last Updated

July 14, 2021

Record last verified: 2021-07

Locations

US(1)