Clinical trial NCT03103386: Effects of Fermented Rye Bran Products on Helicobacter Pylori (HP) Infection and Metabolic Risk Factors
Official title: Effects of Fermented Rye Bran Products on HP Infection and Metabolic Risk Factors
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: H. Pylori Infections
Non-communicable Diseases
Keywords: fermented rye bran
H. pylori infections
non-communicable diseases
Lead sponsor: Fudan University
Sponsor class: OTHER
Collaborators: name: Swedish University of Agricultural Sciences
name: Shanghai Zhongye Hospital
First posted: 2017-04-06
Enrollment: 182
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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.

Primary outcomes:
measure: HP infection
timeFrame: 6，12 and 24 weeks
Secondary outcomes:
measure: Analyzes of chronic inflammation
timeFrame: Up to 10 months
measure: Analyzes of blood lipids
timeFrame: 6，12 and 24 weeks
measure: Analyzes of blood glucose and insulin
timeFrame: 6，12 and 24 weeks
measure: Analyzes of alkylresorcinols
timeFrame: Up to 10 months
measure: Analyzes of body weight changes
timeFrame: 6，12 and 24 weeks
measure: Analyzes of gut microbiota
timeFrame: Up to 2 years
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Dept. Nutrition and Food Hygiene, School of Public Health,Fudan University
state: Shanghai
Study officials:
affiliation: Fudan University
name: Gengsheng He, PhD.
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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.
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.
citation: 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.