Effects of Blueberries on Symptoms and Underlying Mechanisms of Functional Gastrointestinal Disorders
试验速览
- 阶段
- 不适用
- 入组人数
- 55
- 试验地点
- 2
- 主要终点
- Change in Gastrointestinal Symptom Rating Scale (GSRS)
研究概览
简要总结
There is extensive pre-clinical evidence for potential health effects of blueberries. These are related, but not exclusively due to their high polyphenol content. This translational, clinical, randomized, cross-over, double-blind, placebo-controlled study will investigate the effects of blueberries in freeze-dried powder form on gastrointestinal and extra-gastrointestinal symptoms and function, as well as specific potential underlying mechanisms, in patients with the overlapping functional gastrointestinal disorders, irritable bowel syndrome and functional dyspepsia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Double-blind
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Fifty-five successive male or female patients with Functional Gastrointestinal Disorders FGID) enrolled from our Gastroenterology Group Practice (GGP) in Bern, Switzerland, classified as having either Irritable Bowel Syndrome (IBS), Functional Dyspepsia (FD) or both according to Rome 4 criteria (Drossman et al 2016; Schmulson et al. 2017)
- •Age between 18 and 50 years
- •Body mass index 18.5-29.9 kg/m2
- •European / Caucasian ethnicity
- •Able to give informed consent in German as documented by signature
排除标准
- •Evidence of clinically significant disease, as assessed by usual clinical practice (history, blood and stool tests, imaging and endoscopy, as clinically required) and by investigator.
- •Colonoscopy, antibiotics or probiotics within 2 weeks before or during the study.
- •Planned dietary modifications (including polyphenol-rich fruit or vegetable smoothies, drinks or diets) or initiation of new treatments during the study period, besides the study interventions.
- •Inability or contraindications to undergo the investigated intervention
- •Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc.
结局指标
主要结局
Change in Gastrointestinal Symptom Rating Scale (GSRS)
时间窗: before and after 6 weeks of each treatment arm
Validated scale of GI symptoms
次要结局
- Change in breath gas concentrations and symptoms scores during fructose breath testing(before and after 6 weeks of each treatment)
- Change in laboratory markers for advanced glycation end products, tight junction proteins(before and after 6 weeks of each treatment)
- Change in cognitive neurological function tests(before and after 6 weeks of each treatment arm)
- Change in musculoskeletal symptoms(before and after 6 weeks of each treatment arm)
研究者
Clive H Wilder-Smith, MD
Dr
Brain-Gut Research Group