H. Pylori Infections, Non-communicable Diseases
Conditions
Keywords
fermented rye bran, H. pylori infections, non-communicable diseases
Brief summary
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
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.
Interventions
DIETARY_SUPPLEMENTintake of food product with a patented fermented rye bran
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.
DIETARY_SUPPLEMENTintake of food product with common refined wheat
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.
Sponsors
Swedish University of Agricultural Sciences
Shanghai Zhongye Hospital
Fudan University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
1. Both men and women are eligible. 2. Age: 20-70 years old. 3. HP: 13C-urea breath test value（DOB）above 4. 4. 50% of the participants should have BMI below or equal to 24 and 50% should have BMI above 24. 5. Willing to consume test products for 12 weeks.
Exclusion criteria
1. Smokers. 2. In medication (except medication for mild hypertension). 3. Having allergies or food intolerance. 4. Having chronic disease, such as type 2 diabetes, cardiovascular disease and cancer. 5. Diagnosis of peptic ulcer. 6. Pregnancy or to be pregnant. 7. Having travel plans in 4 months.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| HP infection | 6，12 and 24 weeks | The primary endpoint is the changes of severity of HP infection indicated by a C13-ureabreath test |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Analyzes of gut microbiota | Up to 2 years | Analyzes of 16S rDNA by Illumina MiSeq with feces |
| Analyzes of chronic inflammation | Up to 10 months | Analyzes of IL-1, IL-2, IL-6, IL-8, IL-10, inf-γ and hs-CRP with 100 µl plasma or serum |
| Analyzes of body weight changes | 6，12 and 24 weeks | — |
| Analyzes of blood glucose and insulin | 6，12 and 24 weeks | Analyzes of the changes of glucose, insulin and HOMA-IR with 150 µl serum or plasma |
| Analyzes of alkylresorcinols | Up to 10 months | Biomarkers of whole grain wheat and rye intake, 200 µl plasma or serum |
| Analyzes of blood lipids | 6，12 and 24 weeks | Analyzes of the changes of total cholesterol, HDL/LDL and TAG with 100 µl serum |
Countries
China
Outcome results
None listed