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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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Fatty Liver Dietary Supplement: Group 1 NRPT Dietary Supplement: Group 2 NRPT Other: Group 3 Placebo Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 111 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : April 18, 2018
Actual Primary Completion Date : May 10, 2020
Actual Study Completion Date : August 17, 2020

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Group 1: 1X dose of NRPT
250 mg of NR and 50 mg of PT
 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.
Experimental: Group 2: 2X dose of NRPT
500 mg of NR and 100 mg of 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.
Placebo Comparator: Group 3: Placebo
Placebo capsules contain microcrystalline cellulose, silicon dioxide and magnesium stearate
 Other: Group 3 Placebo
Four placebo capsules will be taken once daily in the morning for 26 weeks.


Outcome Measures
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Primary Outcome Measures :
  1. 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.


  2. 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.

  3. 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


  4. 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.


Secondary Outcome Measures :
  1. Safety: Adverse Events [ Time Frame: 6 months ]
    To determine the safety of NRPT as measured by number of adverse events and serious adverse events.

  2. 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.


Other Outcome Measures:
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03513523


Locations
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United States, Florida
Indago Research and Health Center
Hialeah, Florida, United States, 33012
Altus Research, Inc.
Lake Worth, Florida, United States, 33461
Lone Star Research Center
Miami, Florida, United States, 33145
Med-Care Research Corp
Miami, Florida, United States, 33165
Legacy Clinical Solutions: Sensible Healthcare, LLC
Ocoee, Florida, United States, 34761
IMIC, Inc
Palmetto Bay, Florida, United States, 33157
Lenus Research & Medical Group
Sweetwater, Florida, United States, 33172
United States, Nebraska
Barrett Clinic, P.C.
La Vista, Nebraska, United States, 68128
United States, North Carolina
Trial Management Associates, LLC
Wilmington, North Carolina, United States, 28403
Sponsors and Collaborators
Elysium Health
Nutrasource Pharmaceutical and Nutraceutical Services, Inc.
Investigators
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Principal Investigator: Oliver Chen, PhD Biofortis Clinical Research, Inc.
More Information
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Responsible Party: Elysium Health
ClinicalTrials.gov Identifier: NCT03513523    
Other Study ID Numbers: ELYS-170004-FL-PR
First Posted: May 1, 2018    Key Record Dates
Last Update Posted: October 26, 2020
Last Verified: October 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Fatty Liver
Liver Diseases
Digestive System Diseases