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

Not Applicable

Active, not recruiting

• Conditions: Non-communicable Diseases; H. Pylori Infections
• Interventions: Dietary Supplement: intake of food product with common refined wheat; Dietary Supplement: intake of food product with a patented fermented rye bran

• Registration Number: NCT03103386
• Lead Sponsor: Fudan University

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.

Study Timeline

• Study Start: 2015-04
• Primary Completion: 2015-09
• Study First Submitted: 2016-12-23
• Study First Submitted QC: 2017-03-31
• Study First Posted: 2017-04-06
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-11
• Last Update Posted: 2023-06-13
• Study Completion: 2023-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 182

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Refined Wheat group	intake of food product with common refined wheat	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.
Fermented Rye Bran group	intake of food product with a patented fermented rye bran	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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 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 gut microbiota	Up to 2 years	Analyzes of 16S rDNA by Illumina MiSeq with feces
Analyzes of blood lipids	6，12 and 24 weeks	Analyzes of the changes of total cholesterol, HDL/LDL and TAG with 100 µl serum
Analyzes of alkylresorcinols	Up to 10 months	Biomarkers of whole grain wheat and rye intake, 200 µl plasma or serum
Analyzes of body weight changes	6，12 and 24 weeks

Trial Locations

Locations (1)

Dept. Nutrition and Food Hygiene, School of Public Health,Fudan University; 🇨🇳 Shanghai, Shanghai, China