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

Non-communicable Diseases Clinical Trial

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

Status Active, not recruiting

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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

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

• NCT number: NCT03103386
• Study type: Interventional
• Source: Fudan University
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 2015
• Completion date: December 2023