Clinical trial NCT03513523: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fatty Liver
Lead sponsor: Elysium Health
Sponsor class: INDUSTRY
Collaborators: name: Nutrasource Pharmaceutical and Nutraceutical Services, Inc.
First posted: 2018-05-01
Enrollment: 111
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Change in Fatty Liver Index
timeFrame: 6 months
measure: Change in Hepatic Fat Fraction
timeFrame: 6 months
measure: Change in Insulin Resistance (HOMA-IR)
timeFrame: 6 months
measure: Change in liver fat content
timeFrame: 6 months
Secondary outcomes:
measure: Safety: Adverse Events
timeFrame: 6 months
measure: Safety: LFT's
timeFrame: 6 months
Other outcomes:
measure: Exploratory: Change in Inflammatory Marker (hsCRP)
timeFrame: 6 months
Locations:
city: Hialeah
country: United States
facility: Indago Research and Health Center
state: Florida
city: Lake Worth
country: United States
facility: Altus Research, Inc.
state: Florida
city: Miami
country: United States
facility: Lone Star Research Center
state: Florida
city: Miami
country: United States
facility: Med-Care Research Corp
state: Florida
city: Ocoee
country: United States
facility: Legacy Clinical Solutions: Sensible Healthcare, LLC
state: Florida
city: Palmetto Bay
country: United States
facility: IMIC, Inc
state: Florida
city: Sweetwater
country: United States
facility: Lenus Research & Medical Group
state: Florida
city: La Vista
country: United States
facility: Barrett Clinic, P.C.
state: Nebraska
city: Wilmington
country: United States
facility: Trial Management Associates, LLC
state: North Carolina
Study officials:
affiliation: Biofortis Clinical Research, Inc.
name: Oliver Chen, PhD
role: PRINCIPAL_INVESTIGATOR
References: