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

NCT03513523 | Completed

• 1 other identifier: ELYS-170004-FL-PR
• Study Type: interventional
• Target: 111
• Locations: 1 country
• Sites: 9

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.

Conditions

Fatty Liver

Outcome Measures

Primary Outcomes (4)

• Change in Fatty Liver Index

  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.

  6 months

• Change in Hepatic Fat Fraction

  Change from Baseline in mean percent HFF across all nine Couinaud segments will be evaluated within each subject and compared between treatment groups.

  6 months

• Change in Insulin Resistance (HOMA-IR)

  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

  6 months

• Change in liver fat content

  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.

  6 months

Secondary Outcomes (2)

• Safety: Adverse Events

  6 months

• Safety: LFT's

  6 months

Other Outcomes (1)

• Exploratory: Change in Inflammatory Marker (hsCRP)

  6 months

Study Arms (3)

Group 1: 1X dose of NRPT

EXPERIMENTAL

250 mg of NR and 50 mg of PT

Dietary Supplement: Group 1 NRPT

Group 2: 2X dose of NRPT

EXPERIMENTAL

500 mg of NR and 100 mg of PT

Dietary Supplement: Group 2 NRPT

Group 3: Placebo

PLACEBO COMPARATOR

Placebo capsules contain microcrystalline cellulose, silicon dioxide and magnesium stearate

Other: Group 3 Placebo

Interventions

Group 1 NRPT DIETARY_SUPPLEMENT

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.

Group 1: 1X dose of NRPT

Group 2 NRPT DIETARY_SUPPLEMENT

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.

Group 2: 2X dose of NRPT

Group 3 Placebo OTHER

Four placebo capsules will be taken once daily in the morning for 26 weeks.

Group 3: Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• MRI-PDFF of at least 15%, as measured at Visit 2 (Baseline).
• Men or women between the ages of 18 and 70 years.
• BMI between 25.0 and 39.9 kg/m2.
• Non-smokers (\>3 months of non-smoking).
• If on a statin regimen, history (\> 1 month) of stable dose.
• Able to understand and cooperate with study procedures, and have signed a written informed consent prior to any study procedures.

You may not qualify if:

• Diagnosis of NASH (Non-Alcoholic Steatohepatitis).
• Bilirubin \>2x ULN
• 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.)
• Subjects with a history of bariatric surgery.
• Significant weight loss (\> 5% body weight) or rapid weight loss (\> 1.6kg/week), within six (6) months of the Screening Visit.
• 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.
• 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.
• 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).
• 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.
• 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.
• History of cancer, other than non-melanoma skin cancer and basal cell carcinoma, within the previous five years.
• Poorly controlled or uncontrolled hypertension (systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥95 mmHg).
• 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).
• Exposure to any investigational agent within four (4) weeks or five (5) half-lives, prior to the Screening Visit.
• Subjects planning to undergo surgery during the study period or up to 1 month after the study

Sponsors & Collaborators

• Elysium Health: lead
• Nutrasource Pharmaceutical and Nutraceutical Services, Inc.: collaborator

Study Sites (9)

Indago Research and Health Center

Hialeah, Florida, 33012, United States

Location

Altus Research, Inc.

Lake Worth, Florida, 33461, United States

Location

Lone Star Research Center

Miami, Florida, 33145, United States

Location

Med-Care Research Corp

Miami, Florida, 33165, United States

Location

Legacy Clinical Solutions: Sensible Healthcare, LLC

Ocoee, Florida, 34761, United States

Location

IMIC, Inc

Palmetto Bay, Florida, 33157, United States

Location

Lenus Research & Medical Group

Sweetwater, Florida, 33172, United States

Location

Barrett Clinic, P.C.

La Vista, Nebraska, 68128, United States

Location

Trial Management Associates, LLC

Wilmington, North Carolina, 28403, United States

Location

Related Publications (1)

• Dellinger RW, Holmes HE, Hu-Seliger T, Butt RW, Harrison SA, Mozaffarian D, Chen O, Guarente L. Nicotinamide riboside and pterostilbene reduces markers of hepatic inflammation in NAFLD: A double-blind, placebo-controlled clinical trial. Hepatology. 2023 Sep 1;78(3):863-877. doi: 10.1002/hep.32778. Epub 2022 Nov 22.

  PMID: 36082508 DERIVED

MeSH Terms

Conditions

Fatty Liver

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases

Study Officials

• Oliver Chen, PhD

  Biofortis Clinical Research, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 20, 2018
• First Posted: May 1, 2018
• Study Start: April 18, 2018
• Primary Completion: May 10, 2020
• Study Completion: August 17, 2020
• Last Updated: October 26, 2020

Record last verified: 2020-10

Locations

US (9)