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



Status:Recruiting
Conditions:Gastrointestinal
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:18 - 70
Updated:11/16/2018
Start Date:April 18, 2018
End Date:May 2019
Contact:Rodney Butt
Email:RButt@nutrasource.ca
Phone:1 905 730 5333

Use our guide to learn which trials are right for you!

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.


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.
We found this trial at
9
sites
Hialeah, Florida 33012
?
mi
from
Hialeah, FL
Click here to add this to my saved trials
4671 S. Congress Ave.
Lake Worth, Florida 33461
561-641-0404
?
mi
from
Lake Worth, FL
Click here to add this to my saved trials
La Vista, Nebraska 68128
Principal Investigator: Kevin Ahlers, MD
Phone: 402-991-9500
?
mi
from
La Vista, NE
Click here to add this to my saved trials
Miami, Florida 33145
?
mi
from
Miami, FL
Click here to add this to my saved trials
Miami, Florida 33165
?
mi
from
Miami, FL
Click here to add this to my saved trials
Ocoee, Florida 34761
Principal Investigator: William Bowman, MD
Phone: 407-654-2724
?
mi
from
Ocoee, FL
Click here to add this to my saved trials
Palmetto Bay, Florida
?
mi
from
Palmetto Bay, FL
Click here to add this to my saved trials
Sweetwater, Florida 33172
?
mi
from
Sweetwater, FL
Click here to add this to my saved trials
Wilmington, North Carolina 28403
Principal Investigator: Barton Williams, MD
Phone: 910-338-1555
?
mi
from
Wilmington, NC
Click here to add this to my saved trials