Effect of "Nicotinamide Mononucleotide" (NMN) on Cardiometabolic Function

NCT ID: NCT03151239

Last Updated: 2021-07-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-07-01

Study Completion Date

2021-06-30

Brief Summary

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

Detailed Description

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This study is is looking at the effect of the dietary supplement "Nicotinamide mononucleotide" (NMN) on key cardiovascular and metabolic functions, specifically those that are important risk factors for diabetes and cardiovascular disease. Accordingly, the investigators will evaluate the effect of NMN on how well the hormone insulin works to control blood sugar. The investigators will also look at the effects of NMN on blood lipids; body fat and liver fat; and other blood, fat tissue and muscle tissue markers of cardiovascular (heart) and metabolic health. Data from studies conducted in rodents have shown that NMN supplementation has beneficial effects on cardiovascular and metabolic health, but this has not yet been studied in people.

Conditions

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Glucose Metabolism Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

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

NMN supplementation

Group Type EXPERIMENTAL

NMN supplement

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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NMN supplement

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

Intervention Type DIETARY_SUPPLEMENT

Placebo

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

Intervention Type OTHER

Other Intervention Names

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nicotinamide mononucleotide

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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.
Minimum Eligible Age

55 Years

Maximum Eligible Age

75 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Washington University School of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Samuel Klein, MD

Role: PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

Locations

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Washington University School of Medicine

St Louis, Missouri, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 33888596 (View on PubMed)

Other Identifiers

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201701096

Identifier Type: -

Identifier Source: org_study_id

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