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NCT Number: NCT06822621

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

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.

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Key information

Conditions

Hypercholesterolemia Body Weight Dyslipidemias Hyperlipidemias Lipid Metabolism Disorders Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Overweight/Obesity Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

25 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National and Kapodistrian University of Athens, School of Medicine

Athens, Attica, 11527, Greece

About this study

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:

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Control

Other

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

Intervention

Other

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

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Harokopio University

Other

Collaborators

  • National and Kapodistrian University of Athens

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Feb 12, 2025
Registry last updated
Feb 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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