Effects of Phytosterol Supplementation on Serum Lipid Profile, Liver Enzymes, Insulin, Adiponectin, and Inflammatory Status in Patients With Nonalcoholic Fatty Liver Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- lab tests
研究概览
简要总结
Non-alcoholic fatty liver disease (NAFLD) is considered one of the most common chronic liver diseases worldwide, it recently became a worldwide problem with high morbidity which requires further attention. The use of natural bioactive products such as phytosterols have shown anti-NAFLD effect with little to no side effects when used as a supplement in the therapeutic protocol of NAFLD, in many animals, and In vitro studies.
Although the positive impacts of phytosterols on the prevention of hypercholesterolemia and improving liver functions have been reported in previous studies, further clinical experiments, especially human studies are needed to assure the effectiveness of phytosterols on improving liver enzymes, lipid profile, and insulin response in patients with NAFLD. In this study, we focus on the efficacy of phytosterol in a dose similar to the therapicutic lifestyle changes diet (TLC) recommendation with an aim to include it in the therapeutic protocol for NAFLD and to study the effect of some confounders that were excluded in previous studies on this relationship.
详细描述
A randomized, double-blind, placebo-controlled, parallel experimental trial will be conducted to explore the therapeutic potential of phytosterol supplementation against NAFLD. Patients with NAFLD will be recruited from Jordan University Hospital, Department of Gastroenterology and Hepatology.
Forty adult patients, males and females, aged less than 70, who are diagnosed with NAFLD by liver ultrasonography, and who are willing to participate will be invited to join the clinical trial and will be informed that they can leave the study whenever they want.
Participants with any history of liver transplantation, tested positive for any type of hepatitis, autoimmune hepatitis, alcohol consumption, current corticosteroids or antibiotics consumption, rapid weight loss, heart failure, renal disease, pregnant and lactating women, patients with BMI higher than 40, or who have unintentional weight loss of 5%, and patients who are consuming other supplements within three months of the study will be excluded.
A specialized physician will examine the patients, confirm the diagnosis, and ensure that all volunteers fit the inclusion criteria.
The 40 patients will be randomly divided into two groups, using a random number generator at randomization.com; the phytosterols group (n=20), who will receive capsulated 2.0g oral phytosterol powder which will be consumed with meals daily, and the control group (n= 20) who will receive a placebo capsule (microcrystalline cellulose) of 2.0g daily. Each intervention will extend for two months, and the actual intervention phases will be preceded by a 2-week run-in period, in which the participants will be asked to refrain from the consumption of high stanols and sterols in their diets.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Care Provider)
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
- 否
入选标准
- •any patient with NAFLD or NASH that has been diagnosed by any type of imaging.
- •ability to swallow pills.
- •ability to take the supplement for 3 months.
排除标准
- •history of liver transplantation.
- •tested positive for any type of hepatitis.
- •diagnosed with autoimmune hepatitis.
- •significant alcohol consumption.
- •current corticosteroids or antibiotics consumption.
- •rapid unintentional weight loss.
- •diagnosed with heart failure.
- •diagnosed with renal disease.
- •pregnant and lactating women.
- •patients with a BMI higher than
- •patients who are consuming other supplements within the last three months.
研究组 & 干预措施
treatment group
干预措施: phytosterols (Dietary Supplement)
control group
干预措施: placebo (Dietary Supplement)
结局指标
主要结局
lab tests
时间窗: from enrollment to the end of 3 months
liver enzymes (ALT, AST, GGT, ALK, Total protein, Direct bilirubin, Total bilirubin) mg/dl
次要结局
- Vital signs(from enrollment to the end of 3 months)
- Anthropometric measures(from enrollment to the end of 3 months)
研究者
Shatha Hammad, Assistant Professor
Assistant professor
University of Jordan