Clinical Effects of Nutrition on Metabolic Risk Factors and Mechanisms
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Region Skane
- 入组人数
- 50
- 主要终点
- Change from baseline in metabolic effects, intestinal permeability and microbiota composition after food intervention
研究概览
简要总结
The overall aim for this study is to evaluate the clinical effects of a modified diet on metabolic risk factors such as diabetes mellitus and obesity, and the mechanisms this nutrition composition exerts on gastrointestinal physiology, inflammatory responses, and quality of life, where the subjects are their own controls.
Within this study, the investigators will be able to relate the nutritional composition to metabolic disorders, the gut microbiota, secreted intestinal neuropeptides, and bio- and inflammatory markers in serum, plasma and urine.
详细描述
Material and Methods
Subjects are recruited consequently from the primary care, and from the Department of Endocrinology.
Study population
The investigator will include:
- patients with type 2 diabetes to study the effect of a modified diet for 3 months;
- healthy volunteers for intake of two different breakfasts with some days in between the meals.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy subjects should be healthy.
- •Prediabetes should have fasting plasma glucose levels o 5.6-6.9 mmol/l or plasma glucose level 2 h after an oral glucose test of 7.8-11.1 mmol/l, without any diabetes treatment.
- •Patients with diabetes should have type-2 diabetes.
- •Obesity should have BMI 30-3 and glucose levels within reference values
排除标准
- •Patients with diabetes or obesity should not have severe cardiac, kidney, liver or psychiatric diseases
研究组 & 干预措施
low carbohydrate food
The subjects will be given a diet with moderate, low carbohydrate content for 3 months, or as a single test meal, and this will be evaluated in metabolic parameters, microbiota and biomarkers in serum as described previously.
Intervention: Food: Low carbohydrate food
干预措施: low carbohydrate food (Dietary Supplement)
standard food
The subjects will be given a diet with standard food as a single test meal, and this will be evaluated in metabolic parameters, microbiota and biomarkers in serum, as described Intervention: Food: Standard food
干预措施: standard food (Dietary Supplement)
结局指标
主要结局
Change from baseline in metabolic effects, intestinal permeability and microbiota composition after food intervention
时间窗: 3 months
In the larger study, the investigator will give the patients a moderate, low carbohydrate food for 3 months and then evaluate the effects in plasma concentration of insulin, fp-glucose, C-peptide, proinsulin, HbA1c, lipids, and zonulin. Feces wil be analyzed for microbiota composition as quantified by PCR.
次要结局
- Quality of life as assessed by the SF-36(3 months)
研究者
Bodil Ohlsson
Professor, senior consultant
Region Skane