NCT03513432已完成不适用
Influence of Beer on Gut Microbiota and Biochemical Outcomes: Alcohol Impact.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Changes in intestinal microbiota from baseline
研究概览
简要总结
Our aim is to assess the effects of moderate consumption of beer and non-alcoholic beer on gut microbiota and biochemical biomarkers in healthy adults.
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
- 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
- Male
- 接受健康志愿者
- 是
入选标准
- •Adult men (18-65 years);
- •Healthy volunteers free of chronic diseases with relevant effect on gastrointestinal system;
- •Without a diagnosis of any digestive disease including functional bowel disorders such as IBS;
- •Moderate alcohol consumers;
- •Willing and able to provide written informed consent.
排除标准
- •Documented cardiovascular disease (ischaemic heart disease - angina or recent or old myocardial infarction or previous or cerebral vascular accident, peripheral vascular disease);
- •With diabetes or other relevant metabolic diseases;
- •With any known infectious diseases, namely infections with HIV, Hepatitis B or C virus;
- •Intake of antibiotics in the last 4 weeks and laxatives in the last 2 weeks;
- •Subjects with history of drug, alcohol or other substances abuse.
结局指标
主要结局
Changes in intestinal microbiota from baseline
时间窗: at visit 1 (after 1-week run-in period) and at visit 2 (after 4-week intake period)
次要结局
- Changes in fasting serum triglycerides from baseline(at visit 1 (after 1-week run-in period) and at visit 2 (after 4-week intake period))
- Changes in fasting serum cHDL from baseline(at visit 1 (after 1-week run-in period) and at visit 2 (after 4-week intake period))
- Changes in Homeostasis Model Assessment-Insulin Resistance (HOMA-IR) from baseline(at visit 1 (after 1-week run-in period) and at visit 2 (after 4-week intake period))
- Changes in fasting serum total cholesterol from baseline(at visit 1 (after 1-week run-in period) and at visit 2 (after 4-week intake period))
- Changes in fasting serum cLDL from baseline(at visit 1 (after 1-week run-in period) and at visit 2 (after 4-week intake period))
- Changes in fasting serum LPS levels from baseline(at visit 1 (after 1-week run-in period) and at visit 2 (after 4-week intake period))
- Changes in body mass index from baseline(at visit 1 (after 1-week run-in period) and at visit 2 (after 4-week intake period))
- Changes in total body fat mass from baseline(at visit 1 (after 1-week run-in period) and at visit 2 (after 4-week intake period))
研究者
研究点 (2)
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