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

NCT06822621 | Enrolling By Invitation

• 1 other identifier: 106/2023_16.11.23
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypercholesterolemia; Overweight/Obesity

Keywords

hypercholesterolemia; bread; beta-glucans; overweight/obesity; gut microbiota

Outcome Measures

Primary Outcomes (1)

• Change of serum total- and LDL-cholesterol concentrations of study participants as determined by biochemical analysis

  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 Outcomes (1)

• Change in the composition of gut microbiota as determined by NGS analysis of fecal samples

  From enrollment to the end of treatment at 8 weeks.

Study Arms (2)

Control group

PLACEBO COMPARATOR

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

Other: Control

Intervention group

ACTIVE COMPARATOR

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

Other: Intervention

Interventions

Control OTHER

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

Control group

Intervention OTHER

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

Intervention group

Eligibility Criteria

• Age: 25 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Harokopio University: lead
• National and Kapodistrian University of Athens: collaborator

Study Sites (1)

National and Kapodistrian University of Athens, School of Medicine

Athens, Attica, 11527, Greece

Location

MeSH Terms

Conditions

Hypercholesterolemia; Overweight; Obesity

Interventions

Methods

Condition Hierarchy (Ancestors)

Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Amalia E Yanni, Senior Researcher

  Harokopio University

  PRINCIPAL INVESTIGATOR

• Alexandros Kokkinos, Professor

  National and Kapodistrian University of Athens, School of Medicine

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Researcher

Study Record Dates

• First Submitted: January 31, 2025
• First Posted: February 12, 2025
• Study Start: September 2, 2024
• Primary Completion: June 30, 2025
• Study Completion: September 30, 2025
• Last Updated: February 12, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)