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

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ClinicalTrials.gov Identifier: NCT03103386
Recruitment Status : Active, not recruiting
First Posted : April 6, 2017
Last Update Posted : March 5, 2019
Sponsor:
Collaborators:
Swedish University of Agricultural Sciences
Shanghai Zhongye Hospital
Information provided by (Responsible Party):
Gengsheng He, Fudan University

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.

Condition or disease Intervention/treatment Phase
H. Pylori Infections Non-communicable Diseases Dietary Supplement: intake of food product with a patented fermented rye bran Dietary Supplement: intake of food product with common refined wheat Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 182 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Fermented Rye Bran Products on HP Infection and Metabolic Risk Factors
Study Start Date : April 2015
Actual Primary Completion Date : September 2015
Estimated Study Completion Date : June 2019

Arm Intervention/treatment
Experimental: Fermented Rye Bran group
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
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.

Placebo Comparator: Refined Wheat group
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
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 Measures :
  1. HP infection [ Time Frame: 6,12 and 24 weeks ]
    The primary endpoint is the changes of severity of HP infection indicated by a C13-ureabreath test


Secondary Outcome Measures :
  1. Analyzes of chronic inflammation [ Time Frame: Up to 10 months ]
    Analyzes of IL-1, IL-2, IL-6, IL-8, IL-10, inf-γ and hs-CRP with 100 µl plasma or serum

  2. Analyzes of blood lipids [ Time Frame: 6,12 and 24 weeks ]
    Analyzes of the changes of total cholesterol, HDL/LDL and TAG with 100 µl serum

  3. Analyzes of blood glucose and insulin [ Time Frame: 6,12 and 24 weeks ]
    Analyzes of the changes of glucose, insulin and HOMA-IR with 150 µl serum or plasma

  4. Analyzes of alkylresorcinols [ Time Frame: Up to 10 months ]
    Biomarkers of whole grain wheat and rye intake, 200 µl plasma or serum

  5. Analyzes of body weight changes [ Time Frame: 6,12 and 24 weeks ]
  6. Analyzes of gut microbiota [ Time Frame: Up to 2 years ]
    Analyzes of 16S rDNA by Illumina MiSeq with feces



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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03103386


Locations
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China, Shanghai
Dept. Nutrition and Food Hygiene, School of Public Health,Fudan University
Shanghai, Shanghai, China, 200032
Sponsors and Collaborators
Fudan University
Swedish University of Agricultural Sciences
Shanghai Zhongye Hospital
Investigators
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Principal Investigator: Gengsheng He, PhD. Fudan University
Publications:
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Responsible Party: Gengsheng He, Professor, Fudan University
ClinicalTrials.gov Identifier: NCT03103386    
Other Study ID Numbers: KEF201196
First Posted: April 6, 2017    Key Record Dates
Last Update Posted: March 5, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Gengsheng He, Fudan University:
fermented rye bran
H. pylori infections
non-communicable diseases
Additional relevant MeSH terms:
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Infection
Communicable Diseases
Noncommunicable Diseases
Chronic Disease
Disease Attributes
Pathologic Processes