NCT03103386

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 182 (actual)
• Sponsor: Fudan University · Academic / Other
• Sex: All
• Age: 20 Years – 70 Years
• Healthy volunteers: Accepted

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.

Conditions

• H. Pylori Infections
• Non-communicable Diseases

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2015-04-01
• Primary completion: 2015-09-01
• Completion: 2023-12-01
• First posted: 2017-04-06
• Last updated: 2023-06-13

Locations

1 site across 1 country: China