A randomized, double blind, placebo-controlled clinical study evaluating the effects of nutraceuticals in participants with non-alcoholic fatty liver disease (NAFLD).
概览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- Life Synergy
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- 1. Liver Steatosis Grade I, II, and III by USG abdomen pelvis
概览
简要总结
Nutraceuticals, bioactive compounds derived from food sources, have shown promise in managing non-alcoholic fatty liver disease (NAFLD), a condition characterized by excessive fat accumulation in the liver not linked to alcohol consumption. Numerous studies suggest that nutraceuticals may offer therapeutic benefits due to their antioxidant, anti-inflammatory, and lipid-lowering properties. Moreover, nutraceuticals appear to exert beneficial effects on insulin resistance, lipid metabolism, and oxidative stress, all of which play a role in NAFLD progression. Nutraceuticals represent a complementary approach to standard interventions like diet, exercise, and pharmacotherapy for managing NAFLD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Adults aged 18 to 60 years (both inclusive), with a Body Mass Index (BMI) ranging from greater than or equal to 25.00 to less than or equal to 32.00 kg per meter square.
- •Confirmed Diagnosis of NAFLD established by imaging (ultrasound, CT scan or MRI), within 3 months of the screening phase for this study.
- •The diagnosis of NAFLD is made according to the American Association for the Study of Liver Diseases (AASLD) criteria (Chalasaniet al.2017) defined as complying following a) There is hepatic steatosis by imaging or histology b) There is no significant alcohol consumption c) There are no competing etiologies for hepatic steatosis d) There are no co-existing causes for chronic liver disease e) With or without deranged liver function tests, defined as serum Aspartate Aminotransferase (AST) or Alanine Aminotransferase (ALT) levels more than 1.5 times the upper limit of normal values.
- •Participant’s demonstration of understanding of study requirements and treatment procedures, and willingness to comply with all protocol required evaluations.
排除标准
- •Presence of alternative causes of fatty liver including heavy consumption of alcohol
- •Weight loss greater than 10 percent in the 6 months before the screening visit
- •HbA1c greater than 6.5 percent and fasting blood glucose greater than 125 mg per dL
- •Use of drugs associated with ALD or NAFLD for more than 12 consecutive weeks in the 1 year before the start of the study, including amiodarone, tamoxifen, methotrexate, systemic glucocorticoids, anabolic steroids, tetracycline, estrogens in doses higher than used in oral contraceptives, valproate, chloroquine, or antiretroviral drugs
- •History of bowel surgery, gastrointestinal (bariatric) surgery or undergoing evaluation for bariatric surgery for obesity, extensive small-bowel resection, or orthotopic liver transplants (OLT) or listed for OLT
- •History of other chronic liver diseases (Viral hepatitis B or C, autoimmune hepatitis, cholestatic and metabolic liver diseases) and hemochromatosis
- •Participant has known cirrhosis (compensated or decompensated) either based on clinical criteria or liver histology or Imaging techniques
- •Participants with unstable cardiovascular disease including, unstable angina, (that is new or worsening symptoms of coronary heart disease within the past 3 months), acute coronary syndrome within the past 6 months, acute myocardial infarction in the past 3 months or heart failure of New York Heart Association class (III IV) or worsening congestive heart failure, or coronary artery intervention, within the past 6 months, uncontrolled hypertension (systolic BP greater than 180 mmHg and or diastolic BP greater than 110 mmHg on two consecutive occasions), stroke or transient ischemic attack within the prior 6 months.
- •History of myopathies or evidence of active muscle disease.
- •History of malignancy in the past 5 years and or active neoplasm.
结局指标
主要结局
1. Liver Steatosis Grade I, II, and III by USG abdomen pelvis
时间窗: 1. At screening and end of the study. | 2. On screening, baseline, and every follow up visit (day 30, day 60, and day 90). | 3. At screening and end of the study. | 4. At screening and end of the study | 5. At screening and end of the study. | 6. At screening and end of the study. | 7. At baseline and end of the study.
2. Severity grading of symptoms such as abdominal pain, abdominal tenderness, nausea, loss of appetite, bloating, fatigue, itchy skin, and jaundice on the 4 point Linkert scale (None, mild, moderate and severe)
时间窗: 1. At screening and end of the study. | 2. On screening, baseline, and every follow up visit (day 30, day 60, and day 90). | 3. At screening and end of the study. | 4. At screening and end of the study | 5. At screening and end of the study. | 6. At screening and end of the study. | 7. At baseline and end of the study.
3. Parameters of liver function test (LFT) like AST, ALT, ALP, bilirubin total, direct and indirect, albumin and globulin
时间窗: 1. At screening and end of the study. | 2. On screening, baseline, and every follow up visit (day 30, day 60, and day 90). | 3. At screening and end of the study. | 4. At screening and end of the study | 5. At screening and end of the study. | 6. At screening and end of the study. | 7. At baseline and end of the study.
4. Serum levels of fasting insulin, fasting plasma blood sugar, and calculated HOMA IR score (insulin resistance)
时间窗: 1. At screening and end of the study. | 2. On screening, baseline, and every follow up visit (day 30, day 60, and day 90). | 3. At screening and end of the study. | 4. At screening and end of the study | 5. At screening and end of the study. | 6. At screening and end of the study. | 7. At baseline and end of the study.
5. Anthropometric parameters like body weight, BMI, and waist circumference
时间窗: 1. At screening and end of the study. | 2. On screening, baseline, and every follow up visit (day 30, day 60, and day 90). | 3. At screening and end of the study. | 4. At screening and end of the study | 5. At screening and end of the study. | 6. At screening and end of the study. | 7. At baseline and end of the study.
6. Parameters in lipid profile like total cholesterol, HDL, LDL, and triglyceride
时间窗: 1. At screening and end of the study. | 2. On screening, baseline, and every follow up visit (day 30, day 60, and day 90). | 3. At screening and end of the study. | 4. At screening and end of the study | 5. At screening and end of the study. | 6. At screening and end of the study. | 7. At baseline and end of the study.
7. Fibrosis Index or score by calculation
时间窗: 1. At screening and end of the study. | 2. On screening, baseline, and every follow up visit (day 30, day 60, and day 90). | 3. At screening and end of the study. | 4. At screening and end of the study | 5. At screening and end of the study. | 6. At screening and end of the study. | 7. At baseline and end of the study.
次要结局
- 1. Assessment of adverse events(2. Assessment of tolerability of investigational products.)
研究者
Dr Ramshyam Agarwal
Lokmanya Medical Research Centre and Hospital