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| Name | Class |
|---|---|
| National and Kapodistrian University of Athens | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group | Placebo Comparator | Dietary intervention with common white wheat bread in mildly hypercholesterolemic subjects with overweight/obesity. |
|
| Intervention group | Active Comparator | Dietary intervention with white wheat bread enriched with oat beta-glucans in mildly hypercholesterolemic subjects with overweight/obesity. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Control | Other | Dietary intervention with common white wheat bread in mildly hypecholesterolemic subjects following a hypocaloric diet. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | From enrollment to the end of treatment at 8 weeks. |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Amalia E Yanni, Senior Researcher | Harokopio University | Principal Investigator |
| Alexandros Kokkinos, Professor | National and Kapodistrian University of Athens, School of Medicine | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National and Kapodistrian University of Athens, School of Medicine | Athens | Attica | 11527 | Greece |
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| ID | Term |
|---|---|
| D006937 | Hypercholesterolemia |
| D050177 | Overweight |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D006949 | Hyperlipidemias |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
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| ID | Term |
|---|---|
| D008722 | Methods |
| ID | Term |
|---|---|
| D008919 | Investigative Techniques |
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| Intervention | Other | Dietary intervention with white wheat bread enriched with oat beta-glucans in mildly hypecholesterolemic subjects following a hypocaloric diet. |
|
| D009750 |
| Nutritional and Metabolic Diseases |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |