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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
Sponsored by
Fudan University
About
Eligibility
Locations
Arms
Outcomes
Full info

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:

  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.

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

First Posted
December 23, 2016
Last Updated
June 11, 2023
Sponsor
Fudan University
Collaborators
Swedish University of Agricultural Sciences, Shanghai Zhongye Hospital
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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
No

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
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.
Arm Title
Refined Wheat group
Arm Type
Placebo Comparator
Arm 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.
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
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
No
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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