Study to Assess the Relationship Between Daily Dosing of NRPT and Changes in Liver Fat in Healthy Volunteers
NCT ID: NCT03513523
Last Updated: 2020-10-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
111 participants
INTERVENTIONAL
2018-04-18
2020-08-17
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
FACTORIAL
TREATMENT
QUADRUPLE
Study Groups
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Group 1: 1X dose of NRPT
250 mg of NR and 50 mg of PT
Group 1 NRPT
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.
Group 2: 2X dose of NRPT
500 mg of NR and 100 mg of PT
Group 2 NRPT
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
Placebo capsules contain microcrystalline cellulose, silicon dioxide and magnesium stearate
Group 3 Placebo
Four placebo capsules will be taken once daily in the morning for 26 weeks.
Interventions
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Group 1 NRPT
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.
Group 2 NRPT
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
Four placebo capsules will be taken once daily in the morning for 26 weeks.
Eligibility Criteria
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Inclusion Criteria
2. Men or women between the ages of 18 and 70 years.
3. BMI between 25.0 and 39.9 kg/m2.
4. Non-smokers (\>3 months of non-smoking).
5. If on a statin regimen, history (\> 1 month) of stable dose.
6. Able to understand and cooperate with study procedures, and have signed a written informed consent prior to any study procedures.
Exclusion Criteria
2. Bilirubin \>2x ULN
3. Other causes of liver inflammation including Hepatitis A, B or C, HIV, confirmed or suspected cirrhosis, Wilson's disease, autoimmune hepatitis, hemochromatosis, alcoholic steatohepatitis, pancreatitis, or prescription medications known to cause liver damage, or known to be hepatotoxic. (Evidence of hepatocellular injury or hepatocyte ballooning.)
4. Subjects with a history of bariatric surgery.
5. Significant weight loss (\> 5% body weight) or rapid weight loss (\> 1.6kg/week), within six (6) months of the Screening Visit.
6. Current or recent (within six (6) months of the Screening Visit) history of significant gastrointestinal, renal, pulmonary, hepatic or biliary disease, endocrine diseases (Type II Diabetes permitted) or other invasive weight loss treatments.
7. Individual taking prescription or over-the-counter medications, including dietary supplements, known to alter lipid metabolism or liver function, within four (4) weeks of randomization.
8. Use of supplements containing pterostilbene, resveratrol, nicotinamide, or niacin, or consumption of red wine (more than 8 oz. per week) or blueberries (more than one serving per week).
9. Pregnant or lactating women or women of childbearing potential who are not using an approved method of contraception. A woman is considered to be of childbearing potential unless she is post-hysterectomy, one or more years postmenopausal, or one or more years following tubal ligation.
10. History of significant cardiovascular or coronary heart disease (CVD or CHD, respectively) as defined as having had a coronary artery bypass procedure, coronary stent or angioplasty, or myocardial infarction in the previous six (6) months.
11. History of cancer, other than non-melanoma skin cancer and basal cell carcinoma, within the previous five years.
12. Poorly controlled or uncontrolled hypertension (systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥95 mmHg).
13. Recent history of prolonged alcohol (\>3 months) use (within past six (6) months) or excessive alcohol use, defined as \>14 drinks per week (one drink = 12 oz. beer, 4 oz. wine, 1.5 oz. hard liquor).
14. Exposure to any investigational agent within four (4) weeks or five (5) half-lives, prior to the Screening Visit.
15. Subjects planning to undergo surgery during the study period or up to 1 month after the study
16. Any serious psychiatric disease or disorder, which, in the opinion of the investigator, would preclude the subject from participating in the study.
17. Any known intolerance to the investigational ingredients of this investigational product.
18. Has a condition the Investigator believes would interfere with the evaluation of the subject, or may put the subject at undue risk during the course of the study, including potentially abnormal lab results, due to a traumatic event.
18 Years
70 Years
ALL
Yes
Sponsors
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Nutrasource Pharmaceutical and Nutraceutical Services, Inc.
NETWORK
Elysium Health
INDUSTRY
Responsible Party
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Principal Investigators
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Oliver Chen, PhD
Role: PRINCIPAL_INVESTIGATOR
Biofortis Clinical Research, Inc.
Locations
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Indago Research and Health Center
Hialeah, Florida, United States
Altus Research, Inc.
Lake Worth, Florida, United States
Lone Star Research Center
Miami, Florida, United States
Med-Care Research Corp
Miami, Florida, United States
Legacy Clinical Solutions: Sensible Healthcare, LLC
Ocoee, Florida, United States
IMIC, Inc
Palmetto Bay, Florida, United States
Lenus Research & Medical Group
Sweetwater, Florida, United States
Barrett Clinic, P.C.
La Vista, Nebraska, United States
Trial Management Associates, LLC
Wilmington, North Carolina, United States
Countries
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References
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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.
Other Identifiers
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ELYS-170004-FL-PR
Identifier Type: -
Identifier Source: org_study_id