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Fatty LiverNCT03513523

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

A study testing Group 1 NRPT and Group 2 NRPT in people with Fatty Liver, run by Elysium Health at 9 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 70 yearsHealthy volunteers can take part
Conditions the study is for
Fatty Liver
What is being tested?
Group 1 NRPT and Group 2 NRPT
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
111 participants
Where
9 sitesUnited States
Study dates
18 Apr 2018to 17 Aug 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
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  • 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
  • Any serious psychiatric disease or disorder, which, in the opinion of the investigator, would preclude the subject from participating in the study.
  • Any known intolerance to the investigational ingredients of this investigational product.
  • 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 locations and contacts

9 sites in 1 country.

9 sites in 1 country

United States9 sites

  • Indago Research and Health Center

    Hialeah, Florida, 33012

  • Barrett Clinic, P.C.

    La Vista, Nebraska, 68128

  • Altus Research, Inc.

    Lake Worth, Florida, 33461

  • Lone Star Research Center

    Miami, Florida, 33145

  • Med-Care Research Corp

    Miami, Florida, 33165

  • Legacy Clinical Solutions: Sensible Healthcare, LLC

    Ocoee, Florida, 34761

  • IMIC, Inc

    Palmetto Bay, Florida, 33157

  • Lenus Research & Medical Group

    Sweetwater, Florida, 33172

  • Trial Management Associates, LLC

    Wilmington, North Carolina, 28403

Other trials in United States

About this study

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

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
Being tested
Group 1 NRPT, Group 2 NRPT, Group 3 Placebo
Medical subject headings
Fatty Liver

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Group 1 NRPTDietary 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 2 NRPTDietary 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 3 PlaceboOther

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

Study groups in NCT03513523
Study groupRoleWhat they receive
Group 1: 1X dose of NRPTExperimental250 mg of NR and 50 mg of PT
Receives: Dietary Supplement: Group 1 NRPT
Group 2: 2X dose of NRPTExperimental500 mg of NR and 100 mg of PT
Receives: Dietary Supplement: Group 2 NRPT
Group 3: PlaceboPlacebo comparatorPlacebo capsules contain microcrystalline cellulose, silicon dioxide and magnesium stearate
Receives: Other: Group 3 Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 6 months

  2. 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.

    Measured: 6 months

  3. 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

    Measured: 6 months

  4. 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.

    Measured: 6 months

Secondary outcomes (2)

  1. Safety: Adverse Events

    To determine the safety of NRPT as measured by number of adverse events and serious adverse events.

    Measured: 6 months

  2. Safety: LFT's

    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.

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 May 2018
  2. Study start18 Apr 2018
  3. Primary completion10 May 2020
  4. Study completion17 Aug 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Factorial
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
111 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03513523
Sponsor's protocol ID
ELYS-170004-FL-PR
Status last verified
Oct 2020
First submitted
20 Mar 2018
Last updated
26 Oct 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 36082508

Questions about this trial

What is this clinical trial studying?

A study testing Group 1 NRPT and Group 2 NRPT in people with Fatty Liver, run by Elysium Health at 9 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Fatty Liver Index (time frame: 6 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03513523, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2020.

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