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

August 20, 2026 updated by: Amalia Yanni, Harokopio University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The effect of consuming the new bread product, a white wheat bread enriched with oat beta-glucans, on metabolic and inflammatory markers after an 8-week dietary intervention in volunteers with overweight/obesity will be studied. The volunteers will be randomly divided into two groups: group 1 (control) which will receive the conventional product i.e., white wheat bread and group 2 (intervention) which will receive the beta-glucans enriched bread. Both products will be consumed in isocaloric amounts and volunteers in both groups will follow a hypocaloric diet.

The following procedures/determinations will take place at the beginning and end of the intervention:

  1. Anthropometric characteristics: weight, height, body mass index (BMI), waist circumference, hip circumference, body composition.
  2. Classical biochemical parameters: glycemic control, lipid profile, liver enzymes, urea, creatinine, uric acid.
  3. Inflammation status.
  4. Estimation of daily energy intake by completing a food consumption frequency questionnaire.
  5. Assessment of physical activity.

At the beginning and at the end of the nutritional intervention, stool collection will take place. The samples will be subjected to microbiological and molecular analysis (Next Generation Sequencing, NGS) to determine the microbial populations and the intestinal microbiome.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Greece
    • Attica
      • Athens, Attica, Greece, 11527
        • National and Kapodistrian University of Athens, School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • no underlying diseases
  • with LDL-cholesterol levels between 115-150 mg/dL
  • with 25<BMI<32 kg/m2
  • with stable body weight in the last 3 months before the intervention
  • with normal diet and exercise habits

Exclusion Criteria:

  • not suffer from diabetes mellitus, cardiovascular disease, chronic renal failure
  • not receive hypolipidemic treatment
  • not receive nutritional supplements that may affect blood lipid levels (eg omega-3 supplements, plant sterols/stanols) or the intestinal microbial flora (probiotics/prebiotics/antibiotics).
  • not be pregnant or lactating
  • not have food allergies
  • not have habits that prevent their compliance with the research protocol

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Control group
Dietary intervention with common white wheat bread in mildly hypercholesterolemic subjects with overweight/obesity.
Other: Control
Dietary intervention with common white wheat bread in mildly hypecholesterolemic subjects following a hypocaloric diet.
Active Comparator: Intervention group
Dietary intervention with white wheat bread enriched with oat beta-glucans in mildly hypercholesterolemic subjects with overweight/obesity.
Other: Intervention
Dietary intervention with white wheat bread enriched with oat beta-glucans in mildly hypecholesterolemic subjects following a hypocaloric diet.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of serum total- and LDL-cholesterol concentrations of study participants as determined by biochemical analysis
Time Frame: From enrollment to the end of treatment at 8 weeks
Positive effect of consumption of the bread enriched with beta-gucans in the reduction of total- and LDL-cholesterol concentrations
From enrollment to the end of treatment at 8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in the composition of gut microbiota as determined by NGS analysis of fecal samples
Time Frame: From enrollment to the end of treatment at 8 weeks.
Positive effect of consumption of the bread enriched with beta-gucans on the composition of gut microbiota of the study participants
From enrollment to the end of treatment at 8 weeks.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Harokopio University

Collaborators

National and Kapodistrian University of Athens

Investigators

  • Principal Investigator: Amalia E Yanni, Senior Researcher, Harokopio University
  • Study Chair: Alexandros Kokkinos, Professor, National and Kapodistrian University of Athens, School of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 2, 2024

Primary Completion (Actual)

June 30, 2025

Study Completion (Actual)

September 30, 2025

Study Registration Dates

First Submitted

January 31, 2025

First Submitted That Met QC Criteria

February 6, 2025

First Posted (Actual)

February 12, 2025

Study Record Updates

Last Update Posted (Actual)

August 21, 2026

Last Update Submitted That Met QC Criteria

August 20, 2026

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 106/2023_16.11.23

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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