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

NCT03103386 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 182

Last updated 2023-06-13

No results posted yet for this study

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.

Conditions

  • H. Pylori Infections
  • Non-communicable Diseases

Interventions

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.

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.

Sponsors & Collaborators

  • Swedish University of Agricultural Sciences

    collaborator OTHER

  • Shanghai Zhongye Hospital

    collaborator UNKNOWN

  • Fudan University

    lead OTHER

Principal Investigators

  • Gengsheng He, PhD. · Fudan University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-04-30
Primary Completion
2015-09-30
Completion
2023-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03103386 on ClinicalTrials.gov