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Completed

NCT Number: NCT03151239

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

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

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Key information

Age range

55 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

NMN supplement

Dietary Supplement

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

Other names: nicotinamide mononucleotide

Placebo

Other

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

Primary outcomes

  1. Change in muscle insulin sensitivity

    Time frame: before and after at least 8 weeks of treatment

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

Secondary outcomes

  1. Changes in liver insulin sensitivity

    Time frame: before and after at least 8 weeks of treatment

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

  2. Change in adipose tissue insulin sensitivity

    Time frame: before and after at least 8 weeks of treatment

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

  3. Change in body fat mass

    Time frame: before and after at least 8 weeks of treatment

    The outcome will be measured by using dual-energy X-ray absorptiometry before and after intervention period.

  4. Change in fat free mass

    Time frame: before and after at least 8 weeks of treatment

    The outcome will be measured by using dual-energy X-ray absorptiometry before and after intervention period.

  5. Changes in intra-abdominal adipose tissue volume

    Time frame: before and after at least 8 weeks of treatment

    The outcome will be measured by using magnetic resonance imaging before and after intervention period.

  6. Changes in intrahepatic triglyceride content

    Time frame: before and after at least 8 weeks of treatment

    The outcome will be measured by using magnetic resonance imaging before and after intervention period.

  7. Changes in blood pressure

    Time frame: before and after at least 8 weeks of treatment

    The outcome will be assessed by measuring blood pressure at rest before and after intervention period.

  8. Changes in plasma glucose concentration

    Time frame: before and after at least 8 weeks of treatment

    The outcome will be determined by plasma glucose concentration after overnight fasting, before and after intervention period.

  9. Changes in fasting insulin

    Time frame: before and after at least 8 weeks of treatment

    The outcome will be determined by plasma insulin concentration after overnight fasting, before and after intervention period.

  10. Changes in fasting free fatty acid

    Time frame: before and after at least 8 weeks of treatment

    The outcome will be determined by plasma free fatty acid concentration after overnight fasting, before and after intervention period.

  11. Changes in tissue NAD content

    Time frame: before and after at least 8 weeks of treatment

    The outcome will be assessed by measuring NAD content before and after intervention period

  12. Changes in protein levels in skeletal muscle insulin signaling

    Time frame: before and after at least 8 weeks of treatment

    The outcome will be determined by Western blot by using samples collected before and after intervention period

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Registry information

Official study title

Effect of NMN (Nicotinomide Mononucleotide) Supplementation on Cardiometabolic Function

Acronym: NMN

Important dates

Study start
2017
Primary completion
2019
Study completion
2021
First posted
May 12, 2017
Registry last updated
Jul 14, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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