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

Primary Purpose

H. Pylori Infections, Non-communicable Diseases

Status

Active

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

intake of food product with a patented fermented rye bran

intake of food product with common refined wheat

About this trial

This is an interventional treatment trial for H. Pylori Infections focused on measuring fermented rye bran, H. pylori infections, non-communicable diseases

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Both men and women are eligible.
Age: 20-70 years old.
HP: 13C-urea breath test value（DOB）above 4.
50% of the participants should have BMI below or equal to 24 and 50% should have BMI above 24.
Willing to consume test products for 12 weeks.

Exclusion Criteria:

Smokers.
In medication (except medication for mild hypertension).
Having allergies or food intolerance.
Having chronic disease, such as type 2 diabetes, cardiovascular disease and cancer.
Diagnosis of peptic ulcer.
Pregnancy or to be pregnant.
Having travel plans in 4 months.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Fermented Rye Bran group

Refined Wheat group

Arm 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.

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.

Outcomes

Primary Outcome Measures

HP infection

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

Secondary Outcome Measures

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

Analyzes of blood lipids

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

Analyzes of blood glucose and insulin

Analyzes of the changes of glucose, insulin and HOMA-IR with 150 µl serum or plasma

Analyzes of alkylresorcinols

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

Analyzes of body weight changes

Analyzes of gut microbiota

Analyzes of 16S rDNA by Illumina MiSeq with feces

Full Information

NCT ID

NCT03103386

First Posted

December 23, 2016

Last Updated

June 11, 2023

Sponsor

Fudan University

Collaborators

Swedish University of Agricultural Sciences, Shanghai Zhongye Hospital

1. Study Identification

Unique Protocol Identification Number

NCT03103386

Brief Title

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

Acronym

RyeClaim

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

April 2015 (undefined)

Primary Completion Date

September 2015 (Actual)

Study Completion Date

December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Fudan University

Collaborators

Swedish University of Agricultural Sciences, Shanghai Zhongye Hospital

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

H. Pylori Infections, Non-communicable Diseases

Keywords

fermented rye bran, H. pylori infections, non-communicable diseases

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

182 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Fermented Rye Bran group

Arm Type

Experimental

Arm Description

Arm Title

Refined Wheat group

Arm Type

Placebo Comparator

Arm Description

Intervention Type

Dietary Supplement

Intervention Name(s)

intake of food product with a patented fermented rye bran

Intervention Description

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.

Intervention Type

Dietary Supplement

Intervention Name(s)

intake of food product with common refined wheat

Intervention Description

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.

Primary Outcome Measure Information:

Title

HP infection

Description

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 Outcome Measure Information:

Title

Analyzes of chronic inflammation

Description

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

Title

Analyzes of blood lipids

Description

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

Time Frame

6，12 and 24 weeks

Title

Analyzes of blood glucose and insulin

Description

Analyzes of the changes of glucose, insulin and HOMA-IR with 150 µl serum or plasma

Time Frame

6，12 and 24 weeks

Title

Analyzes of alkylresorcinols

Description

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

Time Frame

Up to 10 months

Title

Analyzes of body weight changes

Time Frame

6，12 and 24 weeks

Title

Analyzes of gut microbiota

Description

Analyzes of 16S rDNA by Illumina MiSeq with feces

Time Frame

Up to 2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Both men and women are eligible. Age: 20-70 years old. HP: 13C-urea breath test value（DOB）above 4. 50% of the participants should have BMI below or equal to 24 and 50% should have BMI above 24. Willing to consume test products for 12 weeks. Exclusion Criteria: Smokers. In medication (except medication for mild hypertension). Having allergies or food intolerance. Having chronic disease, such as type 2 diabetes, cardiovascular disease and cancer. Diagnosis of peptic ulcer. Pregnancy or to be pregnant. Having travel plans in 4 months.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Gengsheng He, PhD.

Organizational Affiliation

Fudan University

Official's Role

Principal Investigator

Facility Information:

Facility Name

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

City

Shanghai

State/Province

Shanghai

ZIP/Postal Code

200032

Country

China

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

21435084

Citation

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.

Results Reference

background

PubMed Identifier

20980650

Citation

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.

Results Reference

background

PubMed Identifier

20881074

Citation

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.

Results Reference

background

PubMed Identifier

33521037

Citation

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.

Results Reference

derived

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

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