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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 111
- 试验地点
- 9
- 主要终点
- Change in liver fat content
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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/m
- •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.
排除标准
- •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
- •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.
研究组 & 干预措施
Group 1: 1X dose of NRPT
250 mg of NR and 50 mg of PT
干预措施: Group 1 NRPT (Dietary Supplement)
Group 3: Placebo
Placebo capsules contain microcrystalline cellulose, silicon dioxide and magnesium stearate
干预措施: Group 3 Placebo (Other)
Group 2: 2X dose of NRPT
500 mg of NR and 100 mg of PT
干预措施: Group 2 NRPT (Dietary Supplement)
结局指标
主要结局
Change in liver fat content
时间窗: 6 months
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.
Change in Fatty Liver Index
时间窗: 6 months
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.
Change in Hepatic Fat Fraction
时间窗: 6 months
Change from Baseline in mean percent HFF across all nine Couinaud segments will be evaluated within each subject and compared between treatment groups.
Change in Insulin Resistance (HOMA-IR)
时间窗: 6 months
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
次要结局
- Safety: LFT's(6 months)
- Safety: Adverse Events(6 months)