Effects of Fermented Rye Bran Products on Helicobacter Pylori (HP) Infection and Metabolic Risk Factors

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Effects of Fermented Rye Bran Products on HP Infection and Metabolic Risk Factors

Conditions
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H. Pylori Infections, Non-communicable Diseases

Intervention / Treatment
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* Dietary Supplement: intake of food product with a patented fermented rye bran
* Dietary Supplement: intake of food product with common refined wheat


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Both men and women are eligible. Age: 20-70 years old. HP: 13C-urea breath test value（DOB）above 4. 50% of the participants should have BMI below or equal to 24 and 50% should have BMI above 24. Willing to consume test products for 12 weeks. Exclusion Criteria: Smokers. 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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fermented Rye Bran group<br>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. | Dietary Supplement: intake of food product with a patented fermented rye bran<br>* During the treatment period, participants will be provided 2 packages of puff（fermented rye bran）and 2 packages of crisp bread to be included in the daily diet. Participants are free to consume the product any time during the day to facilitate compliance.<br>|
| Placebo Comparator: Refined Wheat group<br>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. | Dietary Supplement: intake of food product with common refined wheat<br>* During the treatment period, participants will be provided 2 packages of puff （common refined wheat）and 2 packages of crisp bread to be included in the daily diet. Participants are free to consume the product any time during the day to facilitate compliance.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HP infection | The primary endpoint is the changes of severity of HP infection indicated by a C13-ureabreath test | 6，12 and 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Analyzes of chronic inflammation | Analyzes of IL-1, IL-2, IL-6, IL-8, IL-10, inf-γ and hs-CRP with 100 µl plasma or serum | Up to 10 months | 
| Analyzes of blood lipids | Analyzes of the changes of total cholesterol, HDL/LDL and TAG with 100 µl serum | 6，12 and 24 weeks | 
| Analyzes of blood glucose and insulin | Analyzes of the changes of glucose, insulin and HOMA-IR with 150 µl serum or plasma | 6，12 and 24 weeks | 
| Analyzes of alkylresorcinols | Biomarkers of whole grain wheat and rye intake, 200 µl plasma or serum | Up to 10 months | 
| Analyzes of body weight changes |  | 6，12 and 24 weeks | 
| Analyzes of gut microbiota | Analyzes of 16S rDNA by Illumina MiSeq with feces | Up to 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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fermented rye bran, H. pylori infections, non-communicable diseases