NCT03103386

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
182

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2015

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

December 23, 2016

Completed
3 months until next milestone

First Posted

Study publicly available on registry

April 6, 2017

Completed
6.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

June 13, 2023

Status Verified

June 1, 2023

Enrollment Period

5 months

First QC Date

December 23, 2016

Last Update Submit

June 11, 2023

Conditions

H. Pylori InfectionsNon-communicable Diseases

Keywords

fermented rye branH. pylori infectionsnon-communicable diseases

Outcome Measures

Primary Outcomes (1)

  • HP infection

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

    6，12 and 24 weeks

Secondary Outcomes (6)

  • Analyzes of chronic inflammation

    Up to 10 months

  • Analyzes of blood lipids

    6，12 and 24 weeks

  • Analyzes of blood glucose and insulin

    6，12 and 24 weeks

  • Analyzes of alkylresorcinols

    Up to 10 months

  • Analyzes of body weight changes

    6，12 and 24 weeks

  • +1 more secondary outcomes

Study Arms (2)

Fermented Rye Bran group

EXPERIMENTAL

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

Refined Wheat group

PLACEBO COMPARATOR

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

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.

Fermented Rye Bran group
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.

Refined Wheat group

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Both men and women are eligible.
  • Age: 20-70 years old.
  • HP: 13C-urea breath test value（DOB）above 4.
  • % 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Shanghai, Shanghai Municipality, 200032, China

Location

Related Publications (4)

  • 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.

    PMID: 21435084BACKGROUND

  • 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.

    PMID: 20980650BACKGROUND

  • 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.

    PMID: 20881074BACKGROUND

  • 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.

    PMID: 33521037DERIVED

MeSH Terms

Conditions

Noncommunicable Diseases

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Gengsheng He, PhD.

    Fudan University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 23, 2016

First Posted

April 6, 2017

Study Start

April 1, 2015

Primary Completion

September 1, 2015

Study Completion

December 1, 2023

Last Updated

June 13, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)