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H. Pylori InfectionsRyeClaimNCT03103386

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

A study testing intake of food product with a patented fermented rye bran and intake of food product with common refined wheat in people with H. Pylori Infections and Non-communicable Diseases, run by Fudan University at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 20 to 70 yearsHealthy volunteers can take part
What is being tested?
intake of food product with a patented fermented rye bran and intake of food product with common refined wheat
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
182 participants
Where
1 siteChina
Study dates
Apr 2015to Dec 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 70 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

China1 site

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

    Shanghai, Shanghai Municipality, 200032

Other trials in China

About this study

Official title: 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.

Read the 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.

Being tested
intake of food product with a patented fermented rye bran, intake of food product with common refined wheat
Keywords
fermented rye bran, H. pylori infections, non-communicable diseases
Medical subject headings
Noncommunicable Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

Study groups in NCT03103386
Study groupRoleWhat they receive
Fermented Rye Bran groupExperimentalIntake 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.
Receives: Dietary Supplement: intake of food product with a patented fermented rye bran
Refined Wheat groupPlacebo comparatorIntake 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.
Receives: Dietary Supplement: intake of food product with common refined wheat

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. HP infection

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

    Measured: 6，12 and 24 weeks

Secondary outcomes (6)

  1. 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

    Measured: Up to 10 months

  2. Analyzes of blood lipids

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

    Measured: 6，12 and 24 weeks

  3. Analyzes of blood glucose and insulin

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

    Measured: 6，12 and 24 weeks

  4. Analyzes of alkylresorcinols

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

    Measured: Up to 10 months

  5. Analyzes of body weight changes

    Measured: 6，12 and 24 weeks

  6. Analyzes of gut microbiota

    Analyzes of 16S rDNA by Illumina MiSeq with feces

    Measured: Up to 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Apr 2017
  2. Study startApr 2015
  3. Primary completionSep 2015
  4. Study completionDec 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
182 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03103386
Sponsor's protocol ID
KEF201196
Acronym
RyeClaim
Status last verified
Jun 2023
First submitted
23 Dec 2016
Last updated
13 Jun 2023
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • 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.

    PubMed 21435084

  • 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.

    PubMed 20980650

  • 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.

    PubMed 20881074

  • Li W, Tang H, Xue K, Ying T, Wu M, Qu Z, Dong C, Jin T, Brunius C, Hallmans G, Aman P, Johansson A, Landberg R, Liu Y, He G. Personalized Microbial Fingerprint Associated with Differential Glycemic Effects of a Whole Grain Rye Intervention on Chinese Adults. Mol Nutr Food Res. 2024 Sep;68(17):e2400274. doi: 10.1002/mnfr.202400274. Epub 2024 Aug 1.

    PubMed 39091068

  • 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.

    PubMed 33521037

Questions about this trial

What is this clinical trial studying?

A study testing intake of food product with a patented fermented rye bran and intake of food product with common refined wheat in people with H. Pylori Infections and Non-communicable Diseases, run by Fudan University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 13 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

HP infection (time frame: 6，12 and 24 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03103386, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2023.

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