Glucose Metabolism Disorders
Conditions
Brief summary
The goal of this proposal is to determine whether the beneficial effects of NMN on metabolic function observed in rodents applies to people.
Detailed description
This study 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.
Interventions
OTHERPlacebo
Intervention will last at least 16 weeks in the form of two capsules.
DIETARY_SUPPLEMENTTreatment
Intervention will last at least 16 weeks in the form of two or three NMN capsules (total of 300 or 450 mg/day).
Sponsors
United States Department of Defense
Washington University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
45 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
* BMI 25.0-50.0 kg/m² * Prediabetes defined as fasting plasma glucose of ≥100 mg/dL, or HbA1C ≥5.7, or HOMA-IR ≥2.5.
Exclusion criteria
* Women who are still having menses * Persons who take niacin, nicotinamide, or other vitamin B3-related supplementation and are not willing to discontinue supplementation for 3 weeks before medical screening and during the entire study period * Persons who consume moderate-large amounts of caffeine daily (\>2 cups of coffee or 8 oz caffeinated drinks per day) or consume less amounts of caffeine but believe withdrawal symptoms (e.g. headache) are likely if caffeine is stopped * Unstable weight (\>3% change during the last 2 months before entering the study)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Muscle Insulin Sensitivity | After 16 weeks of treatment | The outcome (mean change in muscle sensitivity from baseline to after intervention) will be assessed during hyperinsulinemic-euglycemic clamp procedure in conjunction with stable isotopic tracer infusion after intervention period. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Glucose Tolerance | After 16 weeks of treatment | The outcome (mean change in oral glucose tolerance from baseline to after intervention) will be assessed during modified oral glucose tolerance test after the intervention |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORSamuel Klein, MD
Washington University School of Medicine
Participant flow
Recruitment details
56 participants met the inclusion criteria and were randomly assigned in a double-blind fashion to either placebo or NMN.
Baseline characteristics
| Characteristic | — |
|---|---|
| 3-Hour Glucose Under the Concentration Curve | 372 mg/dLx3hr STANDARD_DEVIATION 64 |
| Age, Continuous | 61.9 years STANDARD_DEVIATION 7.2 |
| Muscle Insulin Sensitivity | 506.0 (nmol/kg FFM/min) / (µU/mL) STANDARD_DEVIATION 170 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 38 Participants |
| Sex: Female, Male Female | 15 Participants |
| Sex: Female, Male Male | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 28 | 0 / 28 |
| other Total, other adverse events | 11 / 28 | 10 / 28 |
| serious Total, serious adverse events | 0 / 28 | 0 / 28 |
Outcome results
None listed