CTRI/2012/11/003134招募中4 期
A prospective study to evaluate the effect of NUTRIOSE®FB 06 (dietary ingredient) on lipid profile and other relevant biochemical parameters
Roquette Lestrem0 个研究点目标入组 90 人开始时间: 待定最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 90
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Pms
入排标准
入选标准
- •1.Female subjects aged 30-65 of years of age
- •2.Female subjects of childbearing potential must have negative pregnancy test at screening and must use an appropriate method of contraception
- •3.LDL-cholesterol level 1.3g/L to 1.89g/L
- •4.Non-diabetic subjects
- •5.BMI: 25-30 kg/m2
- •6.Willingness to sign informed consent
排除标准
- •1.History of metabolic disorders (at least 3 of the following is required):
- •a.Waist circumference greator than 35 inches
- •b.Plasma triglycerides greator than 150 mg/dL
- •c.HDL-C less than 50 mg/dL
- •d.Blood pressure greator than or equal to 130/85 mm Hg
- •e.Fasting plasma glucose 110-125 mg/dL
- •2.Severe disease able to influence the results (e.g. nephritic syndrome or cholestasis or any other condition which in PIâ??s discretion would otherwise alter trial results)
- •3.Subjects with high serum triglycerides (defined by more than 250 mg/dL)
- •4.Subjects with high blood pressure (defined by more than 160/100 mm Hg)
- •5.History of severe cardiac disease within the past 6 months
- •6.History of gastrointestinal disease (chronic inflammatory disease, irritable bowel syndrome, inflammatory bowel disease, current diarrhoea, constipation and liver diseases like hepatitis)
- •7.Use of laxatives during previous 2 weeks
- •8.Pregnant and lactating females
- •9.Subjects on oral contraceptives/hormonal/IUCD
- •10.Subjects consuming corticosteroids
- •11.People receiving lipid-lowering drugs (including statins, fibrates, etc.)
- •12.Subjects undergoing excessive physical activity (more than 7 hours per week)
- •13.Subjects known to be allergic to any ingredient present in the study product
- •14.Participation in any other investigational study within the entire study period including the follow-up period
- •15.Consumption of dietary supplements or food containing ingredients with cholesterol lowering effects (e.g.: phytosterols, omega 3, soya beans, etc.)
- •16.Subjects using any alternative treatment like ayurvedic medicine, homeopathic medicine for cholesterol reduction
研究者
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