NCT06822621

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

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

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Harokopio University · Academic / Other
• Sex: All
• Age: 25 Years – 60 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-09-02
• Primary completion: 2025-06-30
• Completion: 2025-09-30
• First posted: 2025-02-12
• Last updated: 2025-02-12

Locations

1 site across 1 country: Greece