Effect of Prebiotic in Type 2 Diabetes (Diabetes and Health Study)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Change of oral glucose tolerance test (OGTT)
研究概览
简要总结
Previous work in 2015/16 has identified changes in the gut microbiota with prebiotic (Molkosan®) supplement. It report significant changes in metabolic health bio-markers and faecal SCFA profile in 18 health adult subjects consuming 20 ml of product twice a day. Improvement in fasting metabolic parameters was observed flowing the intervention period. A reduction on Total Cholesterol, Glucose, Triglycerides and Insulin was observed.
In this study, a lower dose (20ml/d) in subjects with type 2 diabetes will be examed, over an extended period of time (12 week period) to match the profile of the intended consumer and provide preliminary data to support a larger multi-centre trial.
详细描述
The study will be conducted in males and females with type 2 diabetes managed by diet and lifestyle alone.
The participants who meet the inclusion and exclusion criteria of the study will attend a screening visit where they will complete a medical screening and sign the consent form for participation in the study. Participates will visit the Human Nutrition Unit at the Rowett Institute to provide samples at week 0 (baseline), week 6 and week 12.
Participants' height, weight, and blood pressure will also be recorded. The investigators will measure HbA1c by a finger prick blood sample to confirm whether participants are a prediabetic or type 2 diabetic subjects. A 3-day weighed intake food diary will be completed during the initial washout period (minimum of 7 days) of the study in order to note their normal eating habits. No probiotic or prebiotics to be consumed during washout period and study period.
During the study periods, participants will take 20ml of prebiotic daily over the 12 consecutive weeks.
For the study visits, each participant will undergo, on two separated occasions, an OGTT, with and without the product at week 0 (to assess acute effects, prior to chronic ingestion) and at week 12 (to assess acute effects after chronic ingestion). The two OGTTs (with and without test product) will be separated by a period of 48 hr. Thus, each participant will have four OGTTs during the study. To minimise systematic errors, one half of the participants will start with the test product OGTT and the other half will start without product OGTT. The starting order will be determined randomly. Six blood samples will be collected during the course of 3 hours (0, 30, 60, 90,120 and 180 min) using a cannulation after consuming 75 g of Polycal liquid (glucose load). Together with OGTT, breath samples will be taken every 30 min for measuring hydrogen and methane.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
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
- 否
入选标准
- •Impaired glucose tolerance (IGT, identified by HbA1c) or type 2 diabetes (lifestyle management; identified by HbA1c) age 18-65, with BMI 18-40 kg m-2, measured at screening visit.
排除标准
- •Type 1 Diabetes, Severe gastrointestinal disorders (IBD), Kidney disease, Thromboembolic or coagulation disease, Hepatic disease, Alcohol or any other substance abuse, Eating disorders, Unregulated thyroid disease, Antibiotic use within the last 3 months, including proscribed and prescribed use. Current probiotic use or prebiotic use. Medication for glucose regulation. Female with breast feeding.
研究组 & 干预措施
12 type 2 diabetes patients
Long-term dietary (12 weeks) intervention of 20ml of prebiotic per day
干预措施: 20 ml of prebiotic per day (Dietary Supplement)
结局指标
主要结局
Change of oral glucose tolerance test (OGTT)
时间窗: At baseline and 12 weeks prebiotic consumption
Six blood samples will be collected during the course of 3 hours (0, 30, 60, 90,120 and 180 min) using a cannulation after consuming 75 g of Polycal liquid (glucose load). Plasma glucose level will be measured by KONI analysis and
次要结局
- Change of C-peptide levels(At baseline, 6 weeks and 12 weeks prebiotic consumption)
- HbA1c measured by Alere Afinion™ AS100 Analyzer(At baseline and 12 weeks prebiotic consumption)
- Change of BMI (kg/m^2) measurement(At baseline and 12 weeks prebiotic consumption)
- Change of Total Cholesterol levels(At baseline, 6 weeks and 12 weeks prebiotic consumption)
- Change of fermentation markers(At baseline and 12 weeks prebiotic consumption)
- Change of insulin levels(At baseline, 6 weeks and 12 weeks prebiotic consumption)
- Change of GLP-1 levels(At baseline, 6 weeks and 12 weeks prebiotic consumption)
- Change of GIP levels(At baseline, 6 weeks and 12 weeks prebiotic consumption)
- Change of triglyceride levels(At baseline, 6 weeks and 12 weeks prebiotic consumption)
- Change of glucagon levels(At baseline, 6 weeks and 12 weeks prebiotic consumption)
