Effects of Fermented Rye Bran Products on HP Infection and Metabolic Risk Factors
试验速览
- 阶段
- 不适用
- 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.
研究组 & 干预措施
Fermented Rye Bran group
Intake of food product with a patented fermented rye bran: A patented fermented rye bran ingredient for food purpose has been produced through a process where a specific Lactobacillus curvatis strain was incubated with rye bran by Kampffmayer Food Innovation GmbH, Germany. The dried fermented rye bran was incorporated into a whole grain rye crisp bread product (25% on weight basis) commercially available in Sweden and in a novel extruded whole grain rye product (20%) developed by Lantmännen.Two crisp rye bread pieces (2 x 12g) were packed into moisture and air tight portion package. Participants are advised to consume 4 pieces daily. Rye puff was packed into 2 moisture and air tight portion bags. Participants are advised to consume 2 bags daily. Total energy: 518 kcal/day.
干预措施: intake of food product with a patented fermented rye bran (Dietary Supplement)
Refined Wheat group
Intake of food product with common refined wheat: Corresponding crisp bread and extruded product will be produced using refined wheat flour. Two crisp bread pieces (2 x 12 g) were packed into moisture and air tight portion package. Participants are advised to consume 4 pieces daily.Wheat puff was packed into 2 moisture and air tight portion bags. Participants are advised to consume 2 bags daily.Total energy: 513 kcal/day.
干预措施: intake of food product with common refined wheat (Dietary Supplement)
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)