ClinicalTrials.gov

History of Changes for Study: NCT03513523
Study to Assess the Relationship Between Daily Dosing of NRPT and Changes in Liver Fat in Healthy Volunteers
Latest version (submitted October 23, 2020) on ClinicalTrials.gov
  • A study version is represented by a row in the table.
  • Select two study versions to compare. One each from columns A and B.
  • Choose either the "Merged" or "Side-by-Side" comparison format to specify how the two study versions are to be displayed. The Side-by-Side format only applies to the Protocol section of the study.
  • Click "Compare" to do the comparison and show the differences.
  • Select a version's Submitted Date link to see a rendering of the study for that version.
  • The yellow A/B choices in the table indicate the study versions currently compared below. A yellow table row indicates the study version currently being viewed.
  • Hover over the "Recruitment Status" to see how the study's recruitment status changed.
  • Study edits or deletions are displayed in red.
  • Study additions are displayed in green.
Study Record Versions
Version A B Submitted Date Changes
1 April 19, 2018 None (earliest Version on record)
2 May 1, 2018 Recruitment Status, Study Status, Outcome Measures and Contacts/Locations
3 November 13, 2018 Contacts/Locations and Study Status
4 July 15, 2019 Study Status and Arms and Interventions
5 November 4, 2019 Recruitment Status, Study Status, Contacts/Locations and Study Design
6 October 23, 2020 Recruitment Status and Study Status
Comparison Format:

Scroll up to access the controls

Study NCT03513523
Submitted Date:  April 19, 2018 (v1)

Open or close this module Study Identification
Unique Protocol ID: ELYS-170004-FL-PR
Brief Title: Study to Assess the Relationship Between Daily Dosing of NRPT and Changes in Liver Fat in Healthy Volunteers
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
Secondary IDs:
Open or close this module Study Status
Record Verification: April 2018
Overall Status: Not yet recruiting
Study Start: April 2018
Primary Completion: December 2018 [Anticipated]
Study Completion: December 2018 [Anticipated]
First Submitted: March 20, 2018
First Submitted that
Met QC Criteria:
April 19, 2018
First Posted: May 1, 2018 [Actual]
Last Update Submitted that
Met QC Criteria:
April 19, 2018
Last Update Posted: May 1, 2018 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Elysium Health
Responsible Party: Sponsor
Collaborators: Nutrasource Pharmaceutical and Nutraceutical Services, Inc.
Open or close this module Oversight
U.S. FDA-regulated Drug: No
U.S. FDA-regulated Device: No
Data Monitoring: No
Open or close this module Study Description
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:
Open or close this module Conditions
Conditions: Fatty Liver
Keywords:
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Not Applicable
Interventional Study Model: Factorial Assignment
Number of Arms: 3
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation: Randomized
Enrollment: 105 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: Group 1: 250 mg NRPT 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: 500 mg NRPT 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
Group 3 Placebo
Four placebo capsules will be taken once daily in the morning for 26 weeks.
Open or close this module Outcome Measures
Primary Outcome Measures:
1. 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.
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.
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age: 70 Years
Sex: All
Gender Based:
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.
Open or close this module Contacts/Locations
Central Contact Person: Rodney Butt
Telephone: 1 905 730 5333
Email: RButt@nutrasource.ca
Study Officials: Oliver Chen, PhD
Principal Investigator
Tufts Medical Center
Locations:
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Citations:
Links:
Available IPD/Information:

Scroll up to access the controls Scroll to the Study top

U.S. National Library of Medicine | U.S. National Institutes of Health | U.S. Department of Health & Human Services