The Effects of Long-term Arabinoxylan Administration on Intestinal Barrier Function and Innate Immunity
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 46
- 试验地点
- 2
- 主要终点
- The primary objective of this study is to assess the change from baseline intestinal barrier function at 6 weeks, by performing a gut sugar permeability test.
研究概览
简要总结
The higher prevalence of overweight and obesity among the population contributes to increased incidences of chronic metabolic diseases. Obesity is considered a low-grade systemic inflammatory condition through 1) production of pro-inflammatory cytokines by adipose tissue and 2) alterations in intestinal microbiota composition and associated increase in intestinal permeability. Healthcare costs related to these diseases are rising; prevention or delay of onset of disorders associated with overweight is needed. Administration of wheat arabinoxylans (NAXUS), a non-digestible carbohydrate, may change the intestinal microbiota composition and have beneficial effects on gut epithelial barrier, especially on permeability and innate immune function.
Objective: To assess the effects of NAXUS on intestinal barrier function, immune system performance and metabolic control. Prebiotic properties of NAXUS will be studied. Tolerance of the product in different doses will also be investigated.
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
- Triple (Participant, Investigator, Outcomes Assessor)
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
- •Overweight men/women (BMI 28-35 kg/m2)
- •Besides overweight, healthy human beings
- •Fasting glucose <7.0 mmol/L
- •Normal HbA1c (4.4 to 6.2%)
- •Consistently stable body weight for at least 6 months (± 2 kg)
排除标准
- •Type 2 diabetes mellitus (defined as fasting plasma glucose ≥ 7.0 mmol/L);
- •Gastroenterological diseases or abdominal surgery;
- •Cardiovascular diseases, cancer, liver or kidney malfunction, disease with a life expectancy shorter than 5 years;
- •Abuse of products; alcohol (>20 alcoholic consumptions per week) and drugs
- •Plans to lose weight or following a hypocaloric diet;
- •Use of any medication, including vitamin supplementation, except oral contraceptives, within 14 days prior to testing;
- •Regular use of laxation products;
- •Use of antibiotics in the 90 days prior to the start of study.
- •Administration of investigational drugs or participation in any scientific intervention study which may interfere with this study (to be decided by the principle investigator), in the 180 days prior to the study
- •Known pregnancy, lactation (checked by a pregnancy test before start of study)
- •Blood donation within 3 months before study period
- •Prohibited use of pro-, pre- or synbiotics during study period and three months prior to start of study. A list with forbidden products will be provided (E4 PreProbiotics).
- •Self-admitted HIV-positive state
- •History of any side effects towards intake of pro- or prebiotic supplements of any kind
结局指标
主要结局
The primary objective of this study is to assess the change from baseline intestinal barrier function at 6 weeks, by performing a gut sugar permeability test.
时间窗: Baseline and after 6 weeks of administration
次要结局
- To assess the change from baseline local and systemic immune system performance at 6 weeks.(Baseline and after 6 weeks administration)
- To assess the change from baseline prebiotic properties at 3 and 6 weeks, by collecting faecal samples, intestinal contents and mucosal contents.(Baseline, after 3 and after 6 weeks of administration)
- To assess the change from baseline glucose and lipid metabolism at 3 and 6 weeks(Baseline, after 3 and after 6 weeks of adminstration)
- To assess the effect of different doses of NAXUS administration on tolerance and digestive (dys)comfort.(At baseline, after 1 wk of administration, after 2 wks of administration, after 3 wks of administration, after 4 wks of administration, after 5 wks of administration, after 6 wks of administration (in total 7 times))
- To assess the change from baseline intestinal barrier function at 6 weeks, by assessing the tight junction structure and proteins in colonic biopsies.(Baseline and after 6 weeks of administration)
研究者
Bouke Salden
Coordinating Investigator
Maastricht University Medical Center