HypercholesterolemiaNCT06822621
Functional Cereal Products and Contribution to the Regulation of Metabolism and Obesity-induced Chronic Low-grade Inflammation.
A study testing Intervention in people with Hypercholesterolemia and Overweight/Obesity, run by Harokopio University at 1 site in Greece.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 60 years
- Conditions the study is for
- Hypercholesterolemia, Overweight/Obesity
- What is being tested?
- Intervention
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteGreece
- Study dates
- 2 Sep 2024to 30 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Greece1 site
National and Kapodistrian University of Athens, School of Medicine
Athens, Attica, 11527
About this study
Official title: Functional Cereal Products and Contribution to the Regulation of Metabolism and Obesity-induced Chronic Low-grade Inflammation-MetaflammationBread
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:
Read more
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.
Read the 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:
- 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.
- Conditions
- Hypercholesterolemia, Overweight/Obesity
- Being tested
- Control, Intervention
- Keywords
- hypercholesterolemia, bread, beta-glucans, overweight/obesity, gut microbiota
- Medical subject headings
- Hypercholesterolemia, Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ControlOther
Dietary intervention with common white wheat bread in mildly hypecholesterolemic subjects following a hypocaloric diet.
InterventionOther
Dietary intervention with white wheat bread enriched with oat beta-glucans in mildly hypecholesterolemic subjects following a hypocaloric diet.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Placebo comparator | Dietary intervention with common white wheat bread in mildly hypercholesterolemic subjects with overweight/obesity. Receives: Other: Control |
| Intervention group | Active comparator | Dietary intervention with white wheat bread enriched with oat beta-glucans in mildly hypercholesterolemic subjects with overweight/obesity. Receives: Other: Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: From enrollment to the end of treatment at 8 weeks
Secondary outcomes (1)
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
Measured: From enrollment to the end of treatment at 8 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2025
- Study start2 Sep 2024
- Primary completion30 Jun 2025
- Study completion30 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypercholesterolemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Harokopio University
- Sponsor type
- University, hospital or other
- Collaborators
- National and Kapodistrian University of Athens
- Responsible party
- Principal investigator, Amalia Yanni, Harokopio University
- Investigators
- Amalia E Yanni, Senior Researcher, Principal investigator, Harokopio UniversityAlexandros Kokkinos, Professor, Study chair, National and Kapodistrian University of Athens, School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06822621
- Sponsor's protocol ID
- 106/2023_16.11.23
- Status last verified
- Feb 2025
- First submitted
- 31 Jan 2025
- Last updated
- 21 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Cereal Products and Contribution to the Regulation of Metabolism and Obesity-induced Chronic Low-grade Inflammation-MetaflammationBread
- ClinicalTrials.gov ID
- NCT06822621
- Acronym / sponsor ID
- 106/2023_16.11.23
- Conditions
- Hypercholesterolemia, Overweight/Obesity
- Keywords
- hypercholesterolemia, bread, beta-glucans, overweight/obesity, gut microbiota
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Harokopio UniversityUniversity, hospital or other
- Collaborators
- National and Kapodistrian University of Athens
- Study start
- 2 Sep 2024 (actual)
- Primary completion
- 30 Jun 2025 (actual)
- Study completion
- 30 Sep 2025 (actual)
- First posted
- 12 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Placebo comparator | Other: ControlDietary intervention with common white wheat bread in mildly hypercholesterolemic subjects with overweight/obesity. |
| Intervention group | Active comparator | Other: InterventionDietary intervention with white wheat bread enriched with oat beta-glucans in mildly hypercholesterolemic subjects with overweight/obesity. |
Who may qualify
- Ages
- 25 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ControlDietary intervention with common white wheat bread in mildly hypecholesterolemic subjects following a hypocaloric diet. | Other | Control group |
| InterventionDietary intervention with white wheat bread enriched with oat beta-glucans in mildly hypecholesterolemic subjects following a hypocaloric diet. | Other | Intervention group |
Primary outcome
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
1 secondary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2026.
- Individual participant dataSharing planned: No
Related trials for Hypercholesterolemia
Active, not recruitingObservational study
Study Evaluating LDL-C Change and Adherence to Inclisiran Lipid-lowering Therapy in ASCVD
Primary Hypercholesterolemia, Mixed Dyslipidemia
Active, not recruitingPhase 3
A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
Primary Prevention of Atherosclerotic Cardiovascular Disease
RecruitingObservational study
Causes and Natural History of Dyslipidemias
Hypercholesterolemia, Atherosclerosis
Active, not recruitingObservational study
Early Detection of Familial Hypercholesterolaemia in Pre-school Children ( CzeCH-IT)
Familial Hypercholesterolaemia
Not yet recruiting
Penn Family Screening for Familial Hypercholesterolemia (NHLBI R33) Trial 3
Familial Hypercholesterolemia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amalia E Yanni, Senior Researcher principal investigator
Harokopio University
Alexandros Kokkinos, Professor study chair
National and Kapodistrian University of Athens, School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention in people with Hypercholesterolemia and Overweight/Obesity, run by Harokopio University at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2026.