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Study to Assess the Relationship Between Daily Dosing of NRPT and Changes in Liver Fat in Healthy Volunteers

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ClinicalTrials.gov Identifier: NCT03513523
Recruitment Status : Completed
First Posted : May 1, 2018
Last Update Posted : October 26, 2020
Sponsor:
Collaborator:
Nutrasource Pharmaceutical and Nutraceutical Services, Inc.
Information provided by (Responsible Party):
Elysium Health

Tracking Information
First Submitted Date  ICMJE March 20, 2018
First Posted Date  ICMJE May 1, 2018
Last Update Posted Date October 26, 2020
Actual Study Start Date  ICMJE April 18, 2018
Actual Primary Completion Date May 10, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 1, 2018)
  • Change in Fatty Liver Index [ Time Frame: 6 months ]
    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.
  • Change in Hepatic Fat Fraction [ Time Frame: 6 months ]
    Change from Baseline in mean percent HFF across all nine Couinaud segments will be evaluated within each subject and compared between treatment groups.
  • Change in Insulin Resistance (HOMA-IR) [ Time Frame: 6 months ]
    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
  • Change in liver fat content [ Time Frame: 6 months ]
    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.
Original Primary Outcome Measures  ICMJE
 (submitted: April 19, 2018)
  • Change in Fatty Liver Index [ Time Frame: 6 months ]
    Change from Baseline in FLI will be evaluated within each subject and compared between treatment groups.
  • Change in Hepatic Fat Fraction [ Time Frame: 6 months ]
    Change from Baseline in mean percent HFF across all nine Couinaud segments will be evaluated within each subject and compared between treatment groups.
  • Change in Insulin Resistance (HOMA-IR) [ Time Frame: 6 months ]
    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
  • Change in liver fat content [ Time Frame: 6 months ]
    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.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 1, 2018)
  • Safety: Adverse Events [ Time Frame: 6 months ]
    To determine the safety of NRPT as measured by number of adverse events and serious adverse events.
  • Safety: LFT's [ Time Frame: 6 months ]
    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.
Original Secondary Outcome Measures  ICMJE
 (submitted: April 19, 2018)
  • Safety: Adverse Events [ Time Frame: 6 months ]
    To determine the safety of NRPT as measured by number of adverse events and serious adverse events.
  • Safety: LFT's [ Time Frame: 6 months ]
    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
Current Other Pre-specified Outcome Measures
 (submitted: April 19, 2018)
Exploratory: Change in Inflammatory Marker (hsCRP) [ Time Frame: 6 months ]
Change from Baseline in hsCRP will be evaluated within each subject and compared between treatment groups.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Study to Assess the Relationship Between Daily Dosing of NRPT and Changes in Liver Fat in Healthy Volunteers
Official Title  ICMJE A Randomized, Double-Blind, Double-Dummy, Placebo-Controlled Study to Assess the Relationship Between Daily Dosing of NRPT and Changes in Liver Fat in Healthy Volunteers
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Fatty Liver
Intervention  ICMJE
  • Dietary Supplement: 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.
  • Dietary Supplement: 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.
  • Other: Group 3 Placebo
    Four placebo capsules will be taken once daily in the morning for 26 weeks.
Study Arms  ICMJE
  • Experimental: Group 1: 1X dose of NRPT
    250 mg of NR and 50 mg of PT
    Intervention: Dietary Supplement: Group 1 NRPT
  • Experimental: Group 2: 2X dose of NRPT
    500 mg of NR and 100 mg of PT
    Intervention: Dietary Supplement: Group 2 NRPT
  • Placebo Comparator: Group 3: Placebo
    Placebo capsules contain microcrystalline cellulose, silicon dioxide and magnesium stearate
    Intervention: Other: Group 3 Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 4, 2019)
111
Original Estimated Enrollment  ICMJE
 (submitted: April 19, 2018)
105
Actual Study Completion Date  ICMJE August 17, 2020
Actual Primary Completion Date May 10, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. MRI-PDFF of at least 15%, as measured at Visit 2 (Baseline).
  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:

  1. Diagnosis of NASH (Non-Alcoholic Steatohepatitis).
  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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03513523
Other Study ID Numbers  ICMJE ELYS-170004-FL-PR
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Elysium Health
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Elysium Health
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Nutrasource Pharmaceutical and Nutraceutical Services, Inc.
Investigators  ICMJE
Principal Investigator: Oliver Chen, PhD Biofortis Clinical Research, Inc.
PRS Account Elysium Health
Verification Date October 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP