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| Name | Class |
|---|---|
| Swedish University of Agricultural Sciences | OTHER |
| Shanghai Zhongye Hospital | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fermented Rye Bran group | Experimental | 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. |
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| Refined Wheat group | Placebo Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| intake of food product with a patented fermented rye bran | Dietary Supplement | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gengsheng He, PhD. | Fudan University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dept. Nutrition and Food Hygiene, School of Public Health,Fudan University | Shanghai | Shanghai Municipality | 200032 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21435084 | Background | Polyzos SA, Kountouras J, Zavos C, Deretzi G. The association between Helicobacter pylori infection and insulin resistance: a systematic review. Helicobacter. 2011 Apr;16(2):79-88. doi: 10.1111/j.1523-5378.2011.00822.x. | |
| 20980650 | Background | Landberg R, Andersson SO, Zhang JX, Johansson JE, Stenman UH, Adlercreutz H, Kamal-Eldin A, Aman P, Hallmans G. Rye whole grain and bran intake compared with refined wheat decreases urinary C-peptide, plasma insulin, and prostate specific antigen in men with prostate cancer. J Nutr. 2010 Dec;140(12):2180-6. doi: 10.3945/jn.110.127688. Epub 2010 Oct 27. |
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|
| intake of food product with common refined wheat | Dietary Supplement | 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. |
|
| 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 |
| 20881074 | Background | McKeown NM, Troy LM, Jacques PF, Hoffmann U, O'Donnell CJ, Fox CS. Whole- and refined-grain intakes are differentially associated with abdominal visceral and subcutaneous adiposity in healthy adults: the Framingham Heart Study. Am J Clin Nutr. 2010 Nov;92(5):1165-71. doi: 10.3945/ajcn.2009.29106. Epub 2010 Sep 29. |
| 39091068 | Derived | Li W, Tang H, Xue K, Ying T, Wu M, Qu Z, Dong C, Jin T, Brunius C, Hallmans G, Aman P, Johansson A, Landberg R, Liu Y, He G. Personalized Microbial Fingerprint Associated with Differential Glycemic Effects of a Whole Grain Rye Intervention on Chinese Adults. Mol Nutr Food Res. 2024 Sep;68(17):e2400274. doi: 10.1002/mnfr.202400274. Epub 2024 Aug 1. |
| 33521037 | Derived | Xue K, Liu Y, Iversen KN, Mazidi M, Qu Z, Dong C, Jin T, Hallmans G, Aman P, Johansson A, He G, Landberg R. Impact of a Fermented High-Fiber Rye Diet on Helicobacter pylori and Cardio-Metabolic Risk Factors: A Randomized Controlled Trial Among Helicobacter pylori-Positive Chinese Adults. Front Nutr. 2021 Jan 15;7:608623. doi: 10.3389/fnut.2020.608623. eCollection 2020. |
| ID | Term |
|---|---|
| D000073296 | Noncommunicable Diseases |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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