Randomised Placebo-Controlled Clinical Trial to Assess the Medium-term Effect of 3 g/Day of a Beta-glucan on Lipid Profile, Glycemia and Intestinal Health, in Moderately Hypercholesterolemic Subjects
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 85
- 试验地点
- 2
- 主要终点
- 12 hour fasting lipid profile change from the baseline to the end of the intervention period
研究概览
简要总结
This will be a randomized, placebo-controlled, clinical trial carried out on moderately hypercholesterolemic subjects who will consume 3 g per day of beta-glucans, in order to evaluate the effects on lipid profile, glycemia and intestinal function
详细描述
In order to assess the mid term effects of beta-glucans on lipid profile, glycemia and intestinal function, moderately hypercholesterolemic subjects will be involved in a cross-over study and supplemented for 8 weeks with 3 g/day of beta-glucans or placebo. The two intervention periods will be spaced by a 4 week washout period
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
- Single (Participant)
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Total cholesterol between 200 and 240 mg/dL and/or LDL cholesterol between 130 and 190 mg/dL
- •Triglycerides lower than 200 mg/dL
- •Cardiovascular risk at 10 years lower than 10%
- •Informed consent
排除标准
- •Secondary prevention for cardiovascular diseases
- •TG > 400 mg/dL, HDL-C < 35 mg/dL
- •BMI higher than 30
- •Assumption of lipid lowering drug or supplement with fibre or probiotics during the last 2 months
- •Alcohol abuse
- •Food allergy
- •Alterations in thyroid, liver, or kidney functions, muscle diseases
- •Diabetes, irritable bowel syndrome or chronic disturbed gut function
研究组 & 干预措施
Beta-glucans
Beta-glucans, 3 g per day, per 8 weeks, at breakfast
干预措施: Beta-glucans (Dietary Supplement)
Placebo
Placebo, 3 g per day, per 8 weeks, at breakfast
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
12 hour fasting lipid profile change from the baseline to the end of the intervention period
时间窗: At the screening visit (4 weeks before the randomization one), at the randomization visit (week 0), after 4 and 8 weeks of treatment in both intervention periods (up to 24 weeks overall)
12 hour fasting glycemia change from the baseline to the end of the intervention period
时间窗: At the screening visit (4 weeks before the randomization one), at the randomization visit (week 0), after 4 and 8 weeks of treatment in both intervention periods (up to 24 weeks overall)
次要结局
- Intestinal function from the baseline to the end of the intervention period(At the screening visit (4 weeks before the randomization one), at the randomization visit (week 0), after 4 and 8 weeks of treatment in both intervention periods (up to 24 weeks overall))
- Liver function markers (glutamic oxalacetic transaminase, alanine transaminase, glutamic-pyruvic transaminase, aspartate transaminase) change from the baseline to the end of the intervention period(At the screening visit (4 weeks before the randomization one), at the randomization visit (week 0), after 4 and 8 weeks of treatment in both intervention periods (up to 24 weeks overall))
- Blood pressure change from the baseline to the end of the intervention period(At the screening visit (4 weeks before the randomization one), at the randomization visit (week 0), after 4 and 8 weeks of treatment in both intervention periods (up to 24 weeks overall))
研究者
Claudio Borghi
Chief Internal Medicine Unit
University of Bologna