ButCoIns GUTS: - Gut Immunological Effects of Resistant Starch and Arabinoxylans in Subjects With Metabolic Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 2
- 主要终点
- Feces-short chain fatty acids
研究概览
简要总结
Dietary fibers including resistent starch, RS, and arabinoxylans, AX, have been shown to have anti-inflammatory effects and to change the composition of the faecal micro flora in the colon.
In this unblinded dietary intervention cross-over study 20 subjects with metabolic syndrome are randomized to two types of diet intervention: a low and a high fiber diet. The participants are subjected to endoscopy before and in the end of each intervention.
详细描述
Dietary fibers including resistent starch, RS, and arabinoxylans, AX, have been shown to have anti-inflammatory effects and to change the composition of the faecal micro flora in the colon.
In this unblinded dietary intervention cross-over study 20 subjects with metabolic syndrome are subjected to two types of diet intervention:
- a western style diet, WSD, with a low fiber content and
- a healthy carbohydrate diet, HCD, a high fiber diet. Between the two 4-weeks diet is a wash-out period of four to eight weeks. The participants are subjected to endoscopy with tissue samples before and in the end of each intervention. Fecal and blood samples will be collected at the same time.
We hypothesize that a high content of resistent starch and arabinoxylans increases colonic butyrate concentration, changes colon's mucosal immune system and the microbiota.
A small pilot study will be carried out on 12 healthy volunteers in order to obtain a reference to participants with metabolic syndrome. The healthy volunteers will be subjected to an endoscopy but no dietary intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Health Services Research
- 盲法
- None
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
- 是
入选标准
- •At least 3 out of 5 following criteria:
- •Central obesity (Female > 80 cm, Male > 94 cm)
- •HDL cholesterol (Female < 1,03 mmol/L, Male < 1,29 mmol/L)
- •Bloodpressure (> 130/85 mmHg)
- •Fasting Blood Glucose > 5,6 mmol/L
排除标准
- •Gastrointestinal disease
- •Serious liver, heart or kidney disease
- •Anticoagulation treatment
- •Corticosteroid treatment
- •Waist circumference above 130 cm
- •Alcohol or drug addiction
- •Pregnancy or lactation
结局指标
主要结局
Feces-short chain fatty acids
时间窗: Baseline and 4 weeks
Concentration of short chain fatty acids
次要结局
- Change in production of pro inflammatory cytokines on mucosal level (IFN-γ, TNF-α, IL-17).(Baseline and 4 weeks)
- Change in production of regulatory cytokines on mucosal level and in peripheral blood mononuclear cell (IL-22, IL-10 TNF-β).(Baseline and 4 weeks)
- Activation of T-cells in mucosa described by reduced expression of CD25 and CD69.(Baseline and 4 weeks)
- A change in gut microbiome evaluated by 16 S-RNA analysis(Baseline and 4 weeks)
- Change in Nuclear Factor-kappa B (NF-кB) described by gene expression analysis.(Baseline and 4 weeks)