Nutraceutical Improvement of Glucose Metabolism, NAFLD and Insulin Resistance by Oat-fiber Supplementation in Type 2 Diabetes Mellitus Patients
试验速览
- 阶段
- 不适用
- 入组人数
- 92
- 试验地点
- 1
- 主要终点
- change in glucose tolerance (mixed-meal test)
研究概览
简要总结
Cohort studies show an association between increased intake of insoluble (cereal) fiber and decreased risk for cardiovascular disease, type 2 diabetes (T2DM), non-alcoholic fatty liver disease (NAFLD), cancer, infectious and inflammatory disorders. Intervention studies, specifically addressing non-fermentable carbohydrates instead of their food sources (whole grain, pulses, legumes) are still sparse. Whole grain trials reported beneficial effects, but cannot pinpoint these benefits on fiber, as minerals, vitamins, grain protein and food matrix contribute to the metabolic results.
The antidiabetic effectiveness of cereal fiber might be explained by a) an increased secretion of incretins and other glucose-induced gastrointestinal hormones, b) an alteration of the gut microbiome, or c) a fermentation to short-chain fatty acids. Fermentable fibers (most of which are soluble) show these mechanisms, but lack strong diabetes-protective associations in cohort studies. In recent supplementation trials, insoluble, mostly non-fermentable fibers improved insulin resistance, glycemia and inflammation in patients with metabolic syndrome or prediabetes.
Between 2022-2024, we want to assess the effectiveness of insoluble, poorly fermentable cereal fiber in a shorter Intervention period in patients with high responsiveness (insulin-naïve overt type 2 diabetes mellitus with insulin resistance and NAFLD), using a fiber drinking supplement. Our triple-blinded RCT compares the metabolic effects and mechanistic outcomes of isocaloric treatments with 15 grams of oat-fiber supplement per day (vs. placebo) in 92 patients, covering an intervention period of 12 weeks.
详细描述
Cohort studies show an association between increased intake of insoluble (cereal) fiber and decreased risk for cardiovascular disease, type 2 diabetes (T2DM), non-alcoholic fatty liver disease (NAFLD), cancer, infectious and inflammatory disorders. Intervention studies, specifically addressing non-fermentable carbohydrates instead of their food sources (whole grain, pulses, legumes) are still sparse. Whole grain trials reported beneficial effects, but cannot pinpoint these benefits on fiber, as minerals, vitamins, grain protein and food matrix contribute to the metabolic results.
The antidiabetic effectiveness of cereal fiber might be explained by a) an increased secretion of incretins and other glucose-induced gastrointestinal hormones, b) an alteration of the gut microbiome, or c) a fermentation to short-chain fatty acids. Fermentable fibers (most of which are soluble) show these mechanisms, but lack strong diabetes-protective associations in cohort studies. In recent supplementation trials, insoluble, mostly non-fermentable fibers improved insulin resistance, glycemia and inflammation in patients with metabolic syndrome or prediabetes.
Between 2022-2024, we want to assess the effectiveness of insoluble, poorly fermentable cereal fiber in a shorter Intervention period in patients with high responsiveness (insulin-naïve overt type 2 diabetes mellitus with insulin resistance and NAFLD), using an oat fiber drinking supplement. Our triple-blinded RCT compares the metabolic effects and mechanistic outcomes of isocaloric treatments with 15 grams of oat-fiber supplement per day (vs. placebo) in 92 patients, covering an intervention period of 12 weeks.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
blinding applies to participants, study personnel and statistician
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •type 2 diabetes mellitus
- •HOMA-IR > 2.5
- •NAFLD (MR-S > 5,56 %)
排除标准
- •insulin treatment
- •diabetes type 1, 3 or 4
- •severe cardiopulmonary, renal, inflammatory, gastrointestinal, psychiatric or endocrine disorder
- •alcohol abuse or excess alcohol intake
- •recent CVD event (< 3months)
- •relevant liver disease other than NAFLD
- •current cancer diagnosis or treatment
- •allergy or incompatibility to the supplement
研究组 & 干预措施
Supplementation with insoluble cereal fiber
Drinking powder supplement providing 7,5 grams of insoluble fiber per sachet, taken twice daily over a period of 12 weeks without any changes in dietary behavior, caloric intake or physical activity
干预措施: Drinking powder supplement (Dietary Supplement)
Supplementation with placebo
Drinking powder supplement providing no insoluble fiber, but maltodextrin, taken twice daily over a period of 12 weeks without any changes in dietary behavior, caloric intake or physical activity
干预措施: Drinking powder supplement (Dietary Supplement)
结局指标
主要结局
change in glucose tolerance (mixed-meal test)
时间窗: 12 weeks
change in glucose tolerance (mixed-meal test)
change in insulin resistance (Matsuda)
时间窗: 12 weeks
change in insulin resistance (Matsuda)
change in liver fat content (MRS)
时间窗: 12 weeks
change in liver fat content (MRS)
次要结局
- change in HbA1c(12 weeks)
- change in incretins (GLP-1, GIP, PYY)(12 weeks)
- change in FGF21(12 weeks)
- change in fasting glucose(12 weeks)
- change in inflammation parameters (CRP, leucocytes, IL-6, IL-1ß, IL-18, IL-10, IL-22(12 weeks)
- change in IGF-1 and its binding proteins(12 weeks)
研究者
Stefan Kabisch
Study physician
Charite University, Berlin, Germany