Effects of Non-alcoholic Beer in Patients With Type 2 Diabetes: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Changes in fasting capillary blood glucose from baseline to visit 2 and 3
研究概览
简要总结
The aim of the study is to investigate the effects of non-alcoholic beer in patients with type 2 diabetes. Subjects will be divided into two groups: the control group, where participants will be consuming a bottle of water (330ml) every day for 12 weeks, and the intervention group, where participants will be consuming a bottle of non-alcoholic beer (330ml) for the same period.
详细描述
This is a parallel, controlled randomized trial. The study will compare the effect of non-alcoholic beer consumption with water, in patients with type 2 diabetes.
All patients from both groups will receive a personalized nutritional intervention and will be followed throughout the study by a certified nutritionist.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women diagnosed with type 2 diabetes mellitus, according to the American Diabetes Association criteria;
- •Ages 40-80 years;
- •Non-smoker;
- •Willing and able to provide written informed consent.
排除标准
- •Changes in oral glycaemic-control medications in the last 3 months;
- •Subjects with HbA1c levels under 6.4% or above 10%;
- •Subjects under insulinotherapy;
- •Subjects with triglycerides levels above 4.52 nmol/L(400 mg/dL);
- •Intake of antibiotics in the last 12 weeks;
- •Subjects not willing to avoid drinking beer during the study;
- •Subjects with a diagnosis of any digestive disease including functional bowel disorders such as IBS;
- •Pregnant women or women planning to become pregnant during the study.
研究组 & 干预措施
Non-alcoholic beer
Participants will consume non-alcoholic beer (330 ml) every day for 12 weeks.
干预措施: Non-alcoholic beer (Dietary Supplement)
Control Group
Participants will consume a bottle of water (330 ml) every day for 12 weeks.
干预措施: Water (Dietary Supplement)
结局指标
主要结局
Changes in fasting capillary blood glucose from baseline to visit 2 and 3
时间窗: at visit 1 (after 1-week run-in period), visit 2 (after 6-week intake period), visit 3 (after 12-week intake period)
Changes in fasting insulin levels from baseline to visit 2 and 3
时间窗: at visit 1 (after 1-week run-in period), visit 2 (after 6-week intake period), visit 3 (after 12-week intake period)
Changes in HOMA-B from baseline to visit 2 and 3
时间窗: at visit 1 (after 1-week run-in period), visit 2 (after 6-week intake period), visit 3 (after 12-week intake period)
Changes in HbA1c levels from baseline to visit 2 and 3
时间窗: at visit 1 (after 1-week run-in period), visit 2 (after 6-week intake period), visit 3 (after 12-week intake period)
Changes in HOMA-IR from baseline to visit 2 and 3
时间窗: at visit 1 (after 1-week run-in period), visit 2 (after 6-week intake period), visit 3 (after 12-week intake period)
次要结局
- Changes in body mass index from baseline to visit 2 and 3(at visit 1 (after 1-week run-in period), visit 2 (after 6-week intake period), visit 3 (after 12-week intake period))
- Changes in fasting serum triglycerides from baseline to visit 2 and 3(at visit 1 (after 1-week run-in period), visit 2 (after 6-week intake period), visit 3 (after 12-week intake period))
- Changes in total body fat mass from baseline to visit 2 and 3(at visit 1 (after 1-week run-in period), visit 2 (after 6-week intake period), visit 3 (after 12-week intake period))
- Changes in fasting serum low-density lipoprotein (LDL) cholesterol from baseline to visit 2 and 3(at visit 1 (after 1-week run-in period), visit 2 (after 6-week intake period), visit 3 (after 12-week intake period))
- Changes in fasting serum total cholesterol from baseline to visit 2 and 3(at visit 1 (after 1-week run-in period), visit 2 (after 6-week intake period), visit 3 (after 12-week intake period))
- Changes in intestinal microbiota from baseline to visit 2 and 3(at visit 1 (after 1-week run-in period), visit 2 (after 6-week intake period), visit 3 (after 12-week intake period))
- Changes in fasting serum high-density lipoprotein (HDL) cholesterol from baseline to visit 2 and 3(at visit 1 (after 1-week run-in period), visit 2 (after 6-week intake period), visit 3 (after 12-week intake period))