NCT03550287已完成4 期
A Clinical Trial to Evaluate the Effect of a Shiitake Mushroom Extract Supplement on Lipid Profile, Other Cardiovascular Risk Factors and the Microbiota in Subjects With and Moderate Hyperlipidemia
Instituto de Investigación Hospital Universitario La Paz2 个研究点 分布在 1 个国家目标入组 57 人开始时间: 2017年5月8日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 57
- 试验地点
- 2
- 主要终点
- Change from Baseline Total Cholesterol
研究概览
简要总结
Effect of a dietary supplement with Shiitake extracts (Lentinula edodes) on lipid profile and other cardiovascular risk factors in subjects with moderate hyperlipidemia without pharmacological treatment.
详细描述
Prospective, parallel, randomized and double-blind clinical-nutritional study of 8 weeks of duration and 2 study groups (1) Food supplement with extracts of the fungus Shiitake; 2) Placebo supplement with maltodextrin) to evaluate the effect of a food supplement derived from the Shiitake mushroom (Lentinula edodes) on the lipid profile, other cardiovascular risk factors and the intestinal microbiota in subjects with hyperlipidemia moderate without pharmacological treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Men and women from 18 to 65 years old.
- •BMI ≥18.5 and <30 kg/m
- •Adequate cultural level and understanding for the clinical trial.
- •Signed informed consent.
- •Cardiovascular risk <10% to 10 years measured by REGICOR.
- •Total cholesterol ≥ 200 mg/d and at least 2 factors included in the following list:
- •≥ 45 years or women ≥ 55 years.
- •Family history of cardiovascular disease (CVD) in first degree male relative less than 55 years of age and less than 65 years in women.
- •HDL cholesterol: men <40 or women <
- •Triglycerides ≥ 150mg/dL and <200 mg/dL
- •LDL cholesterol ≥ 130mg/dL and < 160mg/dL
- •Willingness to follow a healthy diet, hyperlipidemic control diet and a diet without stanols, sterols and yeast.
- •Social or familiar environment that prevents from accomplishing the dietary treatment
排除标准
- •Individuals diagnosed with Diabetes Mellitus type
- •Individuals diagnosed with Diabetes Mellitus type 2 on pharmacological treatment (unless it is possible the suspension 30 days before the trials).
- •Individuals with dyslipidemia on pharmacological treatment;
- •Individuals with hypertension on pharmacological treatment;
- •Individuals > 60 years smokers with total cholesterol > 200mg/dL or LDL >130mg/dl.
- •Individuals with hypertension on pharmacological treatment uncontrolled.
- •Individuals with hyperthyroidism and hypothyroidism on pharmacological treatment uncontrolled.
- •Individuals allergic to Shiitake (Lentinula edodes)
- •Individuals with chronic diseases (hepatic, kidney, ...)
- •Individuals receiving at least the preceding 2 months a pharmacological treatment that modifies the lipid profile (for example, statins, fibrates, diuretics, corticosteroids, ADOs);
- •Individuals who have participated in the last 6 months in a program or clinical trial to lose weight.
- •Smokers wanting to stop to smoke during the period that clinical trial lasts.
- •Individuals with mental illness.
- •Consume drugs to lose weight during 30 days before starting the study
- •Pregnant or breastfeeding women.
结局指标
主要结局
Change from Baseline Total Cholesterol
时间窗: Week 0 and 8
Total Cholesterol
次要结局
- Change from Baseline Vitamin D(Week 0 and 8)
- Adverse Effects(Week 0, 4 and 8)
- Change from Baseline Markers of oxidation(Week 0 and 8)
- Change from Baseline Satiety Hunger Assessment(Week 0 and 8)
- Sensory Perception(Week 4)
- Change from Baseline Lipid Metabolism Parameters(Week 0 and 8)
- Change from Baseline Inflammation Parameters(Week 0 and 8)
- Total amount of food consumed in 24h(Week 0 and 8)
- Change from Baseline Glucose Parameters(Week 0 and 8)
- Change from Baseline Anthropometric Parameters(Week 0 and 8)
研究者
研究点 (2)
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