NCT06822621Completed
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
Source: ClinicalTrials.gov · Last updated 21 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 60 (actual)
- First submitted
- 31 Jan 2025
- Start date
- 2 Sept 2024
- Primary completion date
- 30 Jun 2025
- Lead sponsor
- Harokopio University
- Diseases
- Obesity, Familial hypercholesterolaemia
- NCT number
- NCT06822621
What you commit to
- Study type: Interventional
- Participants enrolled: 60
- From 2 Sept 2024 to the primary completion date, 30 Jun 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- not suffer from diabetes mellitus, cardiovascular disease, chronic renal failure
- not have food allergies
Other
- 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 habits that prevent their compliance with the research protocol
Who the study is looking for
- 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
Age in the registry: 25 years to 60 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| National and Kapodistrian University of Athens, School of Medicine Coordinator of this site? Confirm its status | Athens | Greece | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.