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

NCT06822621 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2025-02-12

No results posted yet for this study

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.

Conditions

Interventions

OTHER

Control

Dietary intervention with common white wheat bread in mildly hypecholesterolemic subjects following a hypocaloric diet.

OTHER

Intervention

Dietary intervention with white wheat bread enriched with oat beta-glucans in mildly hypecholesterolemic subjects following a hypocaloric diet.

Sponsors & Collaborators

  • National and Kapodistrian University of Athens

    collaborator OTHER

  • Harokopio University

    lead OTHER

Principal Investigators

  • Amalia E Yanni, Senior Researcher · Harokopio University

  • Alexandros Kokkinos, Professor · National and Kapodistrian University of Athens, School of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
25 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-09-02
Primary Completion
2025-06-30
Completion
2025-09-30

Countries

  • Greece

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06822621 on ClinicalTrials.gov