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| Name | Class |
|---|---|
| United States Department of Defense | FED |
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The goal of this proposal is to determine whether the beneficial effects of NMN on metabolic function observed in rodents applies to people.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | At least 16 weeks of placebo. |
|
| NMN supplementation | Experimental | At least 16 weeks of NMN. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Other | Intervention will last at least 16 weeks in the form of two capsules. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Muscle Insulin Sensitivity | The outcome will be assessed during hyperinsulinemic-euglycemic clamp procedure in conjunction with stable isotopic tracer infusion after intervention period. | After at least 16 weeks of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Glucose Tolerance | The outcome will be assessed during modified oral glucose tolerance test after the intervenion | After at least 16 weeks of treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Samuel Klein, MD | Washington University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
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56 participants met the inclusion criteria and were randomly assigned in a double-blind fashion to either placebo or NMN.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | At least 16 weeks of placebo. |
| FG001 | NMN Supplementation | At least 16 weeks of NMN. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | At least 16 weeks of placebo. |
| BG001 | NMN Supplementation | At least 16 weeks of NMN. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Muscle Insulin Sensitivity | The outcome will be assessed during hyperinsulinemic-euglycemic clamp procedure in conjunction with stable isotopic tracer infusion after intervention period. | Posted | Mean | Standard Deviation | (nmol/kg FFM/min) / (µU/mL) | After at least 16 weeks of treatment |
|
|
From enrollment until the end of follow up after 16 weeks of supplementation
We used the adverse events definitions defined by ClinicalTrials.gov
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | At least 16 weeks of placebo. | 0 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cold symptoms | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sarah Farabi | Washington University in St. Louis | 3142735454 | ssfarabi@wustl.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan: Up to date protocol | May 15, 2023 | Jan 28, 2026 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| ID | Term |
|---|---|
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D013812 | Therapeutics |
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| Treatment |
| Dietary Supplement |
Intervention will last at least 16 weeks in the form of two or three NMN capsules (total of 300 or 450 mg/day). |
|
| BG002 |
| Total |
Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Muscle Insulin Sensitivity | Insulin sensitivity expressed as glucose disposal rate divided by plasma insulin concentration during the hyperinsulinemic-euglycemic clamp procedure | Mean | Standard Deviation | (nmol/kg FFM/min) / (µU/mL) |
|
| 3-Hour Glucose Under the Concentration Curve | Total glucose under the concentration curve measured during a 3-hour modified oral glucose tolerance test | Mean | Standard Deviation | mg/dLx3hr |
|
| Participants |
|
|
|
| Secondary | Changes in Glucose Tolerance | The outcome will be assessed during modified oral glucose tolerance test after the intervenion | One person in the placebo group did not complete their Oral Glucose Tolerance test at the post visit. | Posted | Mean | Standard Deviation | mg/dLx3 Hr | After at least 16 weeks of treatment |
|
|
|
|
| 28 |
| 0 |
| 28 |
| 11 |
| 28 |
| EG001 | NMN Supplementation | At least 16 weeks of NMN. | 0 | 28 | 0 | 28 | 10 | 28 |
| Nausea/vomiting/diarrhea | Gastrointestinal disorders | Non-systematic Assessment |
|
| Bruising/hematoma | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Headache | Nervous system disorders | Non-systematic Assessment |
|
| Dizziness/Blurred Vision | Nervous system disorders | Non-systematic Assessment |
|
| Cold sore | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
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