Evaluation of the Hypolipidemic Effect of Bergavit by a Human Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- The Changes of LDL-C of the Subjects.
研究概览
简要总结
Bergavit is a product contains bergamot. Bergamot is an endemic plant of the Calabrian region in southern Italy with a unique profile of flavonoids and flavonoid glycosides present in its juice and albedo, its flavonoids was able to reduce serum levels of lipids and ameliorate the thickening of the arteries through modulating enzymatic activities, anti-oxidation, anti-inflammatory mechanisms and inhibition of monocyte activation and proliferation.The primary outcome of the study the assessment of the the hypolipidemic effect of Bergavit. The secondary outcomes are the assessment of: a) the hypoglycemic effect of Bergavit, b) the activity of Bergavit on weight loss, and c) the hepatoprotective activity of Bergavit.
详细描述
The study duration is 4 months. Subjects will attend clinic visits as follows:
- T0: First visit: assessment of all baseline parameters, Beginning of treatment
- T2: Second visit: assessment only of LDL level, Total cholesterol, ox-LDL, Triglycerides level, fasting glucose.
- T3: Third visit: assessment of all parameters.
- T4: Fourth visit: assessment of all parameters, end of the treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •1 Healthy men and women (40-70 years old);
- •2 Asian subjects with LDL-cholesterol (ranging from 100 to 159; see here below)
- •3 Subjects naïve to statins or other treatment and food supplement that can interfere with the study treatment for the previous 1 month
- •4 Reading, understanding and signed approval of the informative consent
- •5 No vegetarian. Subjects who will continue, expect reserve, their normal lifestyle
- •6 Healthy volunteers without clinical illness diagnosed with relevant effect on the gastrointestinal system or the motility visceral
排除标准
- •1 Subjects <40 and >70 years old
- •2 Clinical history with relevant presence of any disorder or administration of drugs/food supplement that can potentially interfere with the treatment under study
- •3 lack of compliance defined as not using the correct Bergavit dose or placebo for>1 week), and inability to give informed consent
- •4 Subjects who have changed their diet significantly or have been placed on weight reduction products
- •5 Smokers, Obesity subjects, during breast feeding
- •6 Changing the eating habits within the 2 weeks previous the screening
- •7 During the pregnancy of the subjects or of the subjective planning of the study
- •8 Subjects with a history of drug, alcohol and other substance abuse
- •9 Known food intolerance or food allergy
- •10 Subjects involved in a clinical or food study within the previous month
- •11 Subjects who have unstable medical diseases (cardiac arrhythmias or ischemia, uncontrolled hypertension and hypotension, diabetes mellitus, kidney failure)
- •12 Subjects with a history of paralysis or cerebral vascular accident
- •13 Subjects with active cancers or on chemotherapy
结局指标
主要结局
The Changes of LDL-C of the Subjects.
时间窗: 16 weeks
A randomized-double blind trial. The values change of LDL-C between before to after 0, 8, 12, 10 \& 16 weeks.
次要结局
- The changes of Cholesterol of the Subjects.(16 weeks)
研究者
You-Cheng Shen
Associate Professor
Chung Shan Medical University