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

NCT ID: NCT06822621

Last Updated: 2025-02-12

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-02
• Study Completion Date: 2025-09-30

Brief 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.

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.

Conditions

Hypercholesterolemia; Overweight/Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Control group

Dietary intervention with common white wheat bread in mildly hypercholesterolemic subjects with overweight/obesity.

Group Type: PLACEBO_COMPARATOR

Control

Intervention Type: OTHER

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

Intervention group

Dietary intervention with white wheat bread enriched with oat beta-glucans in mildly hypercholesterolemic subjects with overweight/obesity.

Group Type: ACTIVE_COMPARATOR

Intervention

Intervention Type: OTHER

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

Interventions

Control

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

Intervention Type: OTHER

Intervention

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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National and Kapodistrian University of Athens

OTHER

Sponsor Role: collaborator

Harokopio University

OTHER

Sponsor Role: lead

Responsible Party

Amalia Yanni

Senior Researcher

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Amalia E Yanni, Senior Researcher

Role: PRINCIPAL_INVESTIGATOR

Harokopio University

Alexandros Kokkinos, Professor

Role: STUDY_CHAIR

National and Kapodistrian University of Athens, School of Medicine

Locations

National and Kapodistrian University of Athens, School of Medicine

Athens, Attica, Greece

Countries

Greece

Other Identifiers

106/2023_16.11.23

Identifier Type: -

Identifier Source: org_study_id