Effects of Fermented Rye Bran Products on HP Infection and Metabolic Risk Factors
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 182
- 试验地点
- 1
- 主要终点
- HP infection
研究概览
简要总结
The investigators hypothesize that long-term fermented high-fibre rye intake may reduce the Helicobacter pylori infection through dampening inflammation and thereby leading to lower adherence of the bacteria to surfaces.The investigators further hypothesize that that inflammation could be a potential causal link between HP infection and insulin resistance, a risk factor for type 2 diabetes and cardiovascular disease.
详细描述
A randomized, double-blind, 12 week parallel dietary intervention study is conducted to evaluate the effects of the two novel food products containing fermented rye bran in normal weight and overweight men and women with prevalent HP infection. A follow-up is planned at week 24. The primary endpoint is severity of HP infection indicated by a breath test. Secondary endpoints include effects on chronic inflammation, insulin resistance, blood lipids, blood cholesterol,body weight, intestinal microbial clusters et al. The food products given to the treatment group will be a novel breakfast cereal product and a crispbread product containing fermented rye bran. The control product will be corresponding products based on refined wheat.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Both men and women are eligible.
- •Age: 20-70 years old.
- •HP: 13C-urea breath test value（DOB）above
- •50% of the participants should have BMI below or equal to 24 and 50% should have BMI above
- •Willing to consume test products for 12 weeks.
排除标准
- •In medication (except medication for mild hypertension).
- •Having allergies or food intolerance.
- •Having chronic disease, such as type 2 diabetes, cardiovascular disease and cancer.
- •Diagnosis of peptic ulcer.
- •Pregnancy or to be pregnant.
- •Having travel plans in 4 months.
结局指标
主要结局
HP infection
时间窗: 6，12 and 24 weeks
The primary endpoint is the changes of severity of HP infection indicated by a C13-ureabreath test
次要结局
- Analyzes of chronic inflammation(Up to 10 months)
- Analyzes of blood glucose and insulin(6，12 and 24 weeks)
- Analyzes of gut microbiota(Up to 2 years)
- Analyzes of blood lipids(6，12 and 24 weeks)
- Analyzes of alkylresorcinols(Up to 10 months)
- Analyzes of body weight changes(6，12 and 24 weeks)