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| Name | Class |
|---|---|
| ChromaDex, Inc. | INDUSTRY |
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This study will evaluate the effect of repeated doses of Niagen™ on Niagen™ metabolite concentrations in blood, urine and muscle. There will be 3 doses of Niagen™ compared to a placebo. One quarter of subjects will receive the low dose of Niagen™, one quarter will receive the moderate dose of Niagen™, one quarter will receive the higher dose of Niagen™ and one quarter will reveive the placebo.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Niagen™ 100 | Experimental |
| |
| Niagen™ 300 | Experimental |
| |
| Niagen™ 1000 | Experimental |
| |
| Placebo | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Niagen™ 100 | Dietary Supplement |
| ||
| Niagen™ 300 |
| Measure | Description | Time Frame |
|---|---|---|
| Urinary Methylnicotinamide | Change in levels | 8 weeks: from baseline to end of study |
| Measure | Description | Time Frame |
|---|---|---|
| Blood Nicotinamide Riboside Metabolites | Change in levels | 8 weeks: from baseline to end of study |
| Urinary Nicotinamide Riboside Metabolites | Change in levels |
| Measure | Description | Time Frame |
|---|---|---|
| Resting Metabolic Rate | Change in Levels (kcal/day) Assessed by the ReeVue Indirect Calorimeter | 8 weeks: from baseline to end of study |
| Expression profile: Branched Amino Acids | 8 weeks: from baseline to end of study |
Inclusion Criteria:
BMI 25-30kg/m²
If female, subject is not of child bearing potential, which is defined as females who have had a hysterectomy or oophorectomy, bilateral tubal ligation or are post-menopausal (natural or surgically with > 1 year since last menstruation) OR Females of childbearing potential must agree to use a medically approved method of birth control and have a negative urine pregnancy test result. Acceptable methods of birth control include:
Healthy as determined by laboratory results, medical history, and physical exam
Agrees to comply with study procedure
Agrees to maintain current level of physical activity throughout the study and avoid exercising on the day of study visits 3 to 7 (prior to the visit).
Agrees to refrain from consuming caffeine (i.e. coffee) on the days of study visits 3 to 7 (prior to the visit)
Agrees to avoid taking Vitamin B3 (niacin, nicotinic acid,niacinamide) supplements or multivitamins 14 days prior to randomization and for the duration of the study period
Has given voluntary, written, informed consent to participate in the study
Agrees to avoid foods that contain high amounts of tryptophan and niacin and limit their ingestion of foods containing moderate amounts of tryptophan and niacin
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gordon Schacter, MD | KGK Science Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| KGK Synergize Inc. | London | Ontario | N6A 5R8 | Canada |
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| Niagen™ 1000 | Dietary Supplement |
|
| Placebo | Other |
|
| 8 weeks: from baseline to end of study |
| Muscle Nicotinamide Riboside Metabolites | Change in Levels of Metabolites Assessed from Muscle Tissue collected with Micro-Needle Biopsy | 8 weeks: from baseline to end of study |
| Expression profile: high sensitivity C-reactive protein | 8 weeks: from baseline to end of study |
| Incidence of Abnormal Vital Signs | Resting blood pressure | 8 weeks: from baseline to end of study |
| Incidence of Abnormal Laboratory Values | Assessment of hematology and clinical chemistry parameters: CBC, electrolytes (Na, K, CL), AST, ALT, GGT, BUN, HDL, LDL, triglycerides and total cholesterol | 8 weeks: baseline to end of study |
| Incidence of Adverse Events | Review of adverse events | 8 weeks: baseline to end of study |