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

Fudan University182 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

182

Conditions

H. Pylori Infections Non-communicable Diseases

Interventions

intake of food product with a patented fermented rye branDIETARY_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.

intake of food product with common refined wheatDIETARY_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.

Eligibility

Sex: ALLMin age: 20 YearsMax age: 70 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Dept. Nutrition and Food Hygiene, School of Public Health,Fudan University

Shanghai, Shanghai Municipality, China

Outcomes

Primary Outcomes

HP infection

The primary endpoint is the changes of severity of HP infection indicated by a C13-ureabreath test

Time frame: 6，12 and 24 weeks

Secondary Outcomes

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

Time frame: Up to 10 months

Analyzes of blood lipids

Analyzes of the changes of total cholesterol, HDL/LDL and TAG with 100 µl serum

Time frame: 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

Time frame: 6，12 and 24 weeks

Analyzes of alkylresorcinols

Biomarkers of whole grain wheat and rye intake, 200 µl plasma or serum

Time frame: Up to 10 months

Analyzes of body weight changes

Time frame: 6，12 and 24 weeks

Analyzes of gut microbiota

Analyzes of 16S rDNA by Illumina MiSeq with feces

Time frame: Up to 2 years

Data from ClinicalTrials.gov

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