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| Name | Class |
|---|---|
| Nutrasource Pharmaceutical and Nutraceutical Services, Inc. | NETWORK |
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The purpose of this study is to determine if there is a relationship between daily consumption of NRPT, over a six-month (26-week) period, and changes in liver fat accumulation, compared to placebo and change from Baseline in healthy volunteers. In addition, an exploratory assessment of markers of inflammation and liver fat metabolism will be examined.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1: 1X dose of NRPT | Experimental | 250 mg of NR and 50 mg of PT |
|
| Group 2: 2X dose of NRPT | Experimental | 500 mg of NR and 100 mg of PT |
|
| Group 3: Placebo | Placebo Comparator | Placebo capsules contain microcrystalline cellulose, silicon dioxide and magnesium stearate |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Group 1 NRPT | Dietary Supplement | Two capsules of NRPT and two placebo will be taken once daily in the morning for 26 weeks. Each NRPT capsule will contain 125 mg NR and 25 mg PT. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Fatty Liver Index | Change from Baseline in Fatty Liver Index (FLI) will be evaluated within each subject and compared between treatment groups. FLI: = (e^0.953*loge (triglycerides) + 0.139*BMI + 0.718*loge (GGT) + 0.053*waist circumference - 15.745) / (1 + e^0.953*loge (triglycerides) + 0.139*BMI + 0.718*loge (GGT) + 0.053*waist circumference - 15.745) * 100. | 6 months |
| Change in Hepatic Fat Fraction | Change from Baseline in mean percent HFF across all nine Couinaud segments will be evaluated within each subject and compared between treatment groups. | 6 months |
| Change in Insulin Resistance (HOMA-IR) | Change from Baseline in HOMA-IR will be evaluated within each subject and compared between treatment groups. HOMA-IR: = ([glucose x insulin]/450) For this measure, the comparison is between the placebo and the two IP groups at end-of-study | 6 months |
| Change in liver fat content | To determine if there is a dose effect of NRPT on changes from baseline in liver fat content compared to placebo, as determined by MRI-PDFF. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Safety: Adverse Events | To determine the safety of NRPT as measured by number of adverse events and serious adverse events. | 6 months |
| Safety: LFT's | To determine the safety of NRPT as measured by change in liver function tests (AST U/L, ALT U/L, GGT U/L, Alk Phos U/L) from baseline. |
| Measure | Description | Time Frame |
|---|---|---|
| Exploratory: Change in Inflammatory Marker (hsCRP) | Change from Baseline in hsCRP will be evaluated within each subject and compared between treatment groups. | 6 months |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Oliver Chen, PhD | Biofortis Clinical Research, Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Indago Research and Health Center | Hialeah | Florida | 33012 | United States | ||
| Altus Research, Inc. |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36082508 | Derived | Dellinger RW, Holmes HE, Hu-Seliger T, Butt RW, Harrison SA, Mozaffarian D, Chen O, Guarente L. Nicotinamide riboside and pterostilbene reduces markers of hepatic inflammation in NAFLD: A double-blind, placebo-controlled clinical trial. Hepatology. 2023 Sep 1;78(3):863-877. doi: 10.1002/hep.32778. Epub 2022 Nov 22. |
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| Group 2 NRPT | Dietary Supplement | Four capsules of NRPT will be taken once daily in the morning for 26 weeks. Each NRPT capsule will contain 125 mg NR and 25 mg PT. |
|
| Group 3 Placebo | Other | Four placebo capsules will be taken once daily in the morning for 26 weeks. |
|
| 6 months |
| Lake Worth |
| Florida |
| 33461 |
| United States |
| Lone Star Research Center | Miami | Florida | 33145 | United States |
| Med-Care Research Corp | Miami | Florida | 33165 | United States |
| Legacy Clinical Solutions: Sensible Healthcare, LLC | Ocoee | Florida | 34761 | United States |
| IMIC, Inc | Palmetto Bay | Florida | 33157 | United States |
| Lenus Research & Medical Group | Sweetwater | Florida | 33172 | United States |
| Barrett Clinic, P.C. | La Vista | Nebraska | 68128 | United States |
| Trial Management Associates, LLC | Wilmington | North Carolina | 28403 | United States |
| ID | Term |
|---|---|
| D005234 | Fatty Liver |
| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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