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

Non-communicable Diseases Clinical Trial

— RyeClaim  

Official title:

Effects of Fermented Rye Bran Products on HP Infection and Metabolic Risk Factors

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03103386
• Other study ID #: KEF201196
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 2015
• Est. completion date: December 2023

Study information

• Verified date: June 2023
• Source: Fudan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 between HP infection and insulin resistance, a risk factor for type 2 diabetes and cardiovascular disease.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 182
• Est. completion date: December 2023
• Est. primary completion date: September 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Communicable Diseases
• H. Pylori Infections
• Infections
• Non-communicable Diseases
• Noncommunicable Diseases

Intervention

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.
• 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.

Locations

Country	Name	City	State
China	Dept. Nutrition and Food Hygiene, School of Public Health,Fudan University	Shanghai	Shanghai

Sponsors (3)

Lead Sponsor	Collaborator
Fudan University	Shanghai Zhongye Hospital, Swedish University of Agricultural Sciences

Country where clinical trial is conducted

China, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Analyzes of chronic inflammation	Analyzes of IL-1, IL-2, IL-6, IL-8, IL-10, inf-? and hs-CRP with 100 µl plasma or serum	Up to 10 months
Secondary	Analyzes of blood lipids	Analyzes of the changes of total cholesterol, HDL/LDL and TAG with 100 µl serum	6,12 and 24 weeks
Secondary	Analyzes of blood glucose and insulin	Analyzes of the changes of glucose, insulin and HOMA-IR with 150 µl serum or plasma	6,12 and 24 weeks
Secondary	Analyzes of alkylresorcinols	Biomarkers of whole grain wheat and rye intake, 200 µl plasma or serum	Up to 10 months
Secondary	Analyzes of body weight changes		6,12 and 24 weeks
Secondary	Analyzes of gut microbiota	Analyzes of 16S rDNA by Illumina MiSeq with feces	Up to 2 years