Ignite Creation Date:
2024-05-06 @ 9:55 AM
Last Modification Date:
2024-10-26 @ 12:21 PM
Study NCT ID:
NCT03103386
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-06-13
First Post:
2016-12-23
Brief Title:
Effects of Fermented Rye Bran Products on Helicobacter Pylori HP Infection and Metabolic Risk Factors
Sponsor:
Fudan University
Organization:
Fudan University
Study Overview
Official Title:
Effects of Fermented Rye Bran Products on HP Infection and Metabolic Risk Factors
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RyeClaim
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 surfacesThe 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 cholesterolbody 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None