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

Elysium Health

Status: Completed

Conditions: Fatty Liver

Treatments: Dietary Supplement: Group 2 NRPT; Other: Group 3 Placebo; Dietary Supplement: Group 1 NRPT

Study type: Interventional

Funder types: NETWORK; Industry

Identifiers

NCT03513523

ELYS-170004-FL-PR

Details and patient eligibility

About

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.

Enrollment: 111 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Quadruple Blind

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111 participants in 3 patient groups, including a placebo group

Group 1: 1X dose of NRPT

Experimental group

Description:

250 mg of NR and 50 mg of PT

Treatment:

Dietary Supplement: Group 1 NRPT

Group 2: 2X dose of NRPT

Experimental group

Description:

500 mg of NR and 100 mg of PT

Treatment:

Dietary Supplement: Group 2 NRPT

Group 3: Placebo

Placebo Comparator group

Description:

Placebo capsules contain microcrystalline cellulose, silicon dioxide and magnesium stearate

Treatment:

Other: Group 3 Placebo