An interventional study of Control and Intervention in Hypercholesterolemia and Overweight/Obesity, sponsored by Harokopio University. Completed at 1 site in Greece. Open to participants aged 25 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-08-21.
Sponsored by Harokopio University · Not applicable, Interventional, and Prevention
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.
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:
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.
1,238 studies on the registry are indexed under Hypercholesterolemia; 109 are open to participants now.
This study's enrollment of 60 is below the median of 99 across 991 interventional studies indexed under Hypercholesterolemia.
Browse Hypercholesterolemia studies →Harokopio University is the lead sponsor of 65 studies on the registry; 8 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Dietary intervention with common white wheat bread in mildly hypercholesterolemic subjects with overweight/obesity.
Other: Control
Dietary intervention with white wheat bread enriched with oat beta-glucans in mildly hypercholesterolemic subjects with overweight/obesity.
Other: Intervention
Dietary intervention with common white wheat bread in mildly hypecholesterolemic subjects following a hypocaloric diet.
Dietary intervention with white wheat bread enriched with oat beta-glucans in mildly hypecholesterolemic subjects following a hypocaloric diet.
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
Time frame: From enrollment to the end of treatment at 8 weeks
Change in the composition of gut microbiota as determined by NGS analysis of fecal samples
Positive effect of consumption of the bread enriched with beta-gucans on the composition of gut microbiota of the study participants
Time frame: From enrollment to the end of treatment at 8 weeks.
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.
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Harokopio University