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

June 11, 2023 updated by: Gengsheng He, Fudan University

Effects of Fermented Rye Bran Products on HP Infection and Metabolic Risk Factors

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

182

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200032
        • Dept. Nutrition and Food Hygiene, School of Public Health,Fudan University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 68 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Fermented Rye Bran group
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.
Dietary supplement: intake 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.
Placebo Comparator: Refined Wheat group
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.
Dietary supplement: intake 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
HP infection
Time Frame: 6，12 and 24 weeks
The primary endpoint is the changes of severity of HP infection indicated by a C13-ureabreath test
6，12 and 24 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Analyzes of chronic inflammation
Time Frame: 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
Up to 10 months
Analyzes of blood lipids
Time Frame: 6，12 and 24 weeks
Analyzes of the changes of total cholesterol, HDL/LDL and TAG with 100 µl serum
6，12 and 24 weeks
Analyzes of blood glucose and insulin
Time Frame: 6，12 and 24 weeks
Analyzes of the changes of glucose, insulin and HOMA-IR with 150 µl serum or plasma
6，12 and 24 weeks
Analyzes of alkylresorcinols
Time Frame: Up to 10 months
Biomarkers of whole grain wheat and rye intake, 200 µl plasma or serum
Up to 10 months
Analyzes of body weight changes
Time Frame: 6，12 and 24 weeks
6，12 and 24 weeks
Analyzes of gut microbiota
Time Frame: Up to 2 years
Analyzes of 16S rDNA by Illumina MiSeq with feces
Up to 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fudan University

Collaborators

Swedish University of Agricultural Sciences
Shanghai Zhongye Hospital

Investigators

  • Principal Investigator: Gengsheng He, PhD., Fudan University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2015

Primary Completion (Actual)

September 1, 2015

Study Completion (Estimated)

December 1, 2023

Study Registration Dates

First Submitted

December 23, 2016

First Submitted That Met QC Criteria

March 31, 2017

First Posted (Actual)

April 6, 2017

Study Record Updates

Last Update Posted (Estimated)

June 13, 2023

Last Update Submitted That Met QC Criteria

June 11, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KEF201196

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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