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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
111
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.
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.
Four placebo capsules will be taken once daily in the morning for 26 weeks.
Indago Research and Health Center
Hialeah, Florida, United States
Altus Research, Inc.
Lake Worth, Florida, United States
Lone Star Research Center
Miami, Florida, United States
Med-Care Research Corp
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.
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 6 months
Safety: Adverse Events
To determine the safety of NRPT as measured by number of adverse events and serious adverse events.
Time frame: 6 months
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.
Time frame: 6 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Miami, Florida, United States
Legacy Clinical Solutions: Sensible Healthcare, LLC
Ocoee, Florida, United States
IMIC, Inc
Palmetto Bay, Florida, United States
Lenus Research & Medical Group
Sweetwater, Florida, United States
Barrett Clinic, P.C.
La Vista, Nebraska, United States
Trial Management Associates, LLC
Wilmington, North Carolina, United States