NCT02451163已完成2 期
A Randomized, Controlled Clinical Study on the Effect of Polysaccharides From Wheat on Common Cold Infections in Elderly
Clinical Research Center Kiel GmbH2 个研究点 分布在 1 个国家目标入组 247 人开始时间: 2014年9月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 247
- 试验地点
- 2
- 主要终点
- Occurrence of common cold (CC) based on Jackson et al. 1958 and physicians diagnosis
研究概览
简要总结
The aim of the study is to measure the effect of wheat polysaccharides on the occurence of common cold (CC) in elderly during a 12-week consumption period.
详细描述
The study is conducted in the frame of the collaborative project 'FibeBiotics' (No. 289517) (Fibers as support of the Gut and Immune function of Elderly - From polysaccharide compound to health Claim) within the Seventh Framework Programme (FP7) for Research and Technological Development of the European Union (EU).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •men and postmenopausal women aged ≥ 50
- •willingness to abstain as far as possible from food and supplements containing probiotics, prebiotic supplements, other fermented products, supplements containing vitamins and minerals as well as willingness to sustain a low dietary fibre diet for 14 weeks
- •written informed consent
排除标准
- •subjects currently enrolled in another clinical study
- •subjects having finished another clinical study within the last 4 weeks before inclusion
- •surgery or intervention requiring general anaesthesia within 2 months before the study
- •current symptoms of common infectious diseases (CID) of the airways or other organ systems e.g. gastrointestinal tract
- •history of allergic rhinitis, allergic asthma, anaphylactic shock, quincke edema, food allergy (type I allergy)
- •allergy or hypersensitivity to any component of the test product (e. g. wheat, corn)
- •known congenital, acquired or iatrogenic immunodeficiency (e.g. HIV, chemotherapy, immunosuppression)
- •active autoimmune diseases
- •severe chronic disease (COPD, respiratory insufficiency, cancer, IBD, malabsorption, malnutrition, chronic inflammatory diseases, severe renal, hepatic or cardiac diseases)
- •known coeliac disease (gluten enteropathy)
- •chronic systemic or chronic topical treatment likely to interfere with evaluation of the study parameters: antiallergic drugs, antibiotics, intestinal or respiratory antiseptics, anti-rheumatics, antiphlogistics (except aspirin or equivalent products preventing from aggregation of platelets or blood clotting) and steroids prescribed in chronic inflammatory diseases (in the last 4 weeks before inclusion)
- •diabetes mellitus
- •other chronic treatments likely to interfere with study outcome: e.g. laxatives, body weight management and/or medication
- •chronic abdominal pain
- •bowel movement less than 3 times per week
- •subjects, who meet 2 or more Rome III criteria for constipation or who take laxatives on a regular basis
- •vegetarian, vegan diet
- •eating disorders (e.g. anorexia, bulimia)
- •alcohol and drug abuse
- •severe neurological, cognitive or psychiatric diseases
- •subjects not understanding or speaking fluently German
- •legal incapacity
结局指标
主要结局
Occurrence of common cold (CC) based on Jackson et al. 1958 and physicians diagnosis
时间窗: 12 weeks
Occurrence of common cold (= number of subjects affected by at least one common cold episode during intervention) according to self-reporting (questionnaire based on Jackson et al. 1958) and physicians diagnosis.
次要结局
- Cumulative severity of common cold episodes(12 weeks)
研究者
研究点 (2)
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