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

Fudan University

Status: Active, not recruiting

Conditions: H. Pylori Infections; Non-communicable Diseases

Treatments: Dietary Supplement: intake of food product with a patented fermented rye bran; Dietary Supplement: intake of food product with common refined wheat

Study type: Interventional

Funder types: Other

Identifiers

NCT03103386

KEF201196

Details and patient eligibility

About

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.

Full 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.

Enrollment: 182 patients

Sex: All

Ages: 20 to 70 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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182 participants in 2 patient groups, including a placebo group

Fermented Rye Bran group

Experimental group

Description:

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.

Treatment:

Dietary Supplement: intake of food product with a patented fermented rye bran

Refined Wheat group

Placebo Comparator group

Description:

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.

Treatment:

Dietary Supplement: intake of food product with common refined wheat