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| Name | Class |
|---|---|
| Midwest Center for Metabolic and Cardiovascular Research | OTHER |
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The sponsor of this study is ChromaDex, Inc. This is a double-blind, randomized, crossover study to investigate the effects of 300 mg/d and 1000 mg/d TRU NIAGEN (nicotinamide riboside) compared to a placebo control on cognitive function, mood and sleep in men and women over 55 years of age. The trial is managed by Midwest Center for Metabolic and Cardiovascular Research.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Each subject will be randomly assigned to receive placebo for an 8-week treatment period. Subjects will be instructed to take two capsules (placebo) in the morning with breakfast and two capsules (placebo) in the evening with dinner. At the end of each 8-week treatment period subjects will crossover to the next treatment group until all three treatment periods have been completed at 24 weeks. |
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| TRU NIAGEN (nicotinamide riboside) 300 mg/day | Experimental | Each subject will be randomly assigned to receive 300 mg/day of TRU NIAGEN (nicotinamide riboside) for an 8-week treatment period. Subjects will be instructed to take two capsules of TRU NIAGEN in the morning with breakfast and two capsules of TRU NIAGEN in the evening with dinner. At the end of each 8-week treatment period subjects will crossover to the next treatment group until all three treatment periods have been completed at 24 weeks. |
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| TRU NIAGEN (nicotinamide riboside) 1000 mg/day | Experimental | Each subject will be randomly assigned to receive 1000 mg/day of TRU NIAGEN (nicotinamide riboside) for an 8-week treatment period. Subjects will be instructed to take two capsules of TRU NIAGEN in the morning with breakfast and two capsules of TRU NIAGEN in the evening with dinner. At the end of each 8-week treatment period subjects will crossover to the next treatment group until all three treatment periods have been completed at 24 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 300 mg/day of TRU NIAGEN (nicotinamide riboside) | Dietary Supplement | Treatment with 300 mg/day of TRU NIAGEN (nicotinamide riboside) will be administered daily as 4 capsules in a double-blind, randomized, crossover manner for three 8-week treatment periods. Each subject will receive one placebo and two active treatments in a crossover design. The two active treatments are 300 mg/d TRU NIAGEN (nicotinamide riboside) and 1000 mg/d TRU NIAGEN (nicotinamide riboside). |
| Measure | Description | Time Frame |
|---|---|---|
| The primary comparison will be the low dose (300 mg/d nicotinamide riboside) condition to the placebo condition for the change from baseline to the end of each relevant treatment period. | The primary outcome variable will be the difference between treatments in the change from baseline (defined as visit 2 value for each of the three treatment periods) in executive function measured with the CNS Vital Signs test battery, using the standard score. | 8 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MB Clinical Research | Boca Raton | Florida | 33487 | United States |
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Treatments will be administered daily as 4 capsules in a double-blind, randomized, crossover manner for three 8-week treatment periods. Each subject will receive one placebo and two active treatments in a crossover design.
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The study site will be provided placebo and TRU NIAGEN capsules, each labeled with the protocol number, blinded product code, expiration date, batch number, the statement "For Investigational Use Only" and a space to write the subject's initials, screen and date dispensed.
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| 1000 mg/day of TRU NIAGEN (nicotinamide riboside) | Dietary Supplement | Treatment 1000 mg/day of TRU NIAGEN (nicotinamide riboside) will be administered daily as 4 capsules in a double-blind, randomized, crossover manner for three 8-week treatment periods. Each subject will receive one placebo and two active treatments in a crossover design. The two active treatments are 300 mg/d TRU NIAGEN (nicotinamide riboside) and 1000 mg/d TRU NIAGEN (nicotinamide riboside). |
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| Placebo | Dietary Supplement | Treatment with placebo capsules will be administered daily as 4 capsules in a double-blind, randomized, crossover manner for three 8-week treatment periods. Each subject will receive one placebo and two active treatments in a crossover design. The two active treatments are 300 mg/d TRU NIAGEN (nicotinamide riboside) and 1000 mg/d TRU NIAGEN (nicotinamide riboside). |
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| ID | Term |
|---|---|
| C018613 | nicotinamide-beta-riboside |
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