Clinical Trial

Functional Cereal Products and Contribution to the Regulation of Metabolism and Obesity-induced Chronic Low-grade Inflammation.

Enrolling by Invitation
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Record status
This record was last updated February 12, 2025 (before its estimated June 30, 2025 completion). Its status may not reflect the trial's current state.
Summary
The goal of this clinical trial is to find out the possible beneficial effects of a white wheat bread enriched with oat beta-glucans on mildly hypercholesterolemic subjects with overweight/obesity. The main questions it aims to answer are: Does the enriched bread lower total and LDL-cholesterol levels as well as the levels of inflammatory factors of the participants? Does the enriched bread positively change the composition of gut microbiota? Researchers will compare the enriched bread to a common white wheat bread to see if the enriched bread provides additional effect beyond a hypocaloric dietary plan that the participants of both groups are going to follow. Participants will: Take the enriched or the common bread every day for 8 weeks. Visit the clinic once every 2 weeks for checkups and tests.
Trial Details
NCT Number NCT06822621
Lead Sponsor Harokopio University
Collaborators: National and Kapodistrian University of Athens
Conditions Hypercholesterolemia, Overweight/Obesity
Enrollment 60 participants
Start Date 2024-09-02
Primary Completion 2025-06-30 (estimated)
Study Completion 2025-09-30 (estimated)
Updated on ClinicalTrials.gov 2025-02-12