Coronary Arterial Disease (CAD)NCT06747234
Oat Bran and Plasma Lipid and Fecal Bacteria in Coronary Artery Disease Patients
A study testing Oat bran group in people with Coronary Arterial Disease (CAD), run by Shahid Beheshti University of Medical Sciences at 2 sites in Iran.
Trial summary
The development of atherosclerosis is significantly influenced by the interplay between lipid and inflammatory factors. Endotoxemia, defined as the presence of endotoxins, particularly lipopolysaccharides (LPS) derived from Gram-negative bacteria, in the bloodstream, is closely associated with low-grade inflammation. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Coronary Arterial Disease (CAD)
- What is being tested?
- Oat bran group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 2 sitesIran
- Study dates
- 20 May 2025to 24 Dec 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 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with a history of coronary heart disease who have recently undergone coronary angioplasty
Who cannot join
- End-stage renal disease
- Inflammatory bowel syndrome (IBD),
- Recent glucocorticoid or antibiotic treatment,
- Cancer undergoing chemotherapy or radiotherapy,
- Any alteration to the treatment plan, including changes in drug type or surgical intervention
Trial locations and contacts
2 sites in 1 country.
Iran2 sites
Shahid Modaress Hospital
Tehran, Tehran Province
Shahid Modarres Hospital
Tehran, Tehran Province
About this study
Official title: Effect of Oat Bran Supplementation on Plasma Lipid, Selected Fecal Bacteria, and Short-chain Fatty Acids Receptors Gene Expression in Peripheral Blood Mononuclear Cells in Patients With Coronary Artery Disease
The development of atherosclerosis is significantly influenced by the interplay between lipid and inflammatory factors. Endotoxemia, defined as the presence of endotoxins, particularly lipopolysaccharides (LPS) derived from Gram-negative bacteria, in the bloodstream, is closely associated with low-grade inflammation. This chronic, systemic inflammatory response does not reach the severity of acute inflammation but can contribute to the development of atherosclerosis and cardiovascular disease (CVD). Lipopolysaccharide-binding protein (LBP) is a soluble acute-phase protein that binds to bacterial LPS. Elevated levels of LBP have been linked to increased low-grade inflammation, which further exacerbates chronic inflammation and metabolic dysregulation. Dietary fiber, such as oat bran, may have a role in mitigating the effects of endotoxemia and its associated inflammation. Furthermore, dietary fiber could play a role in improving plasma lipid profiles. The present study will investigate the effect of oat bran supplementation on cardiometabolic risk markers, LBP concentrations, selected fecal bacteria, and short-chain fatty acids receptors gene expression in peripheral blood mononuclear cells in patients with coronary artery disease.
Read the detailed description
As stated by the World Health Organization, cardiovascular diseases (CVDs), particularly coronary artery disease (CAD), represent the primary cause of mortality globally. Atherosclerosis, the primary pathophysiological mechanism underlying CAD, is a multifactorial process, with lipids and inflammatory factors playing a pivotal role. One potential cause of chronic inflammation is endotoxemia, which is a condition resulting from the absorption of lipopolysaccharide (LPS) into the circulatory system. LPS is an active component of the cell wall of gram-negative bacteria derived from the gut microbiota and a potent activator of the innate immune system via the toll-like receptor 4 pathway. The entry of LPS into the systemic circulation ultimately results in the intracellular transcription of several inflammatory mediators, which subsequently trigger an inflammatory response. This is recognized as a contributing factor in the development and progression of atherosclerosis and subsequent coronary artery disease. The presence of bacterial 16S ribosomal RNA belonging to the Enterobacterial family has been identified in atherosclerotic plaques. The protein that binds to LPS in the blood is known as LBP (lipopolysaccharide-binding protein). Serum levels of LBP have been demonstrated to be elevated in patients with angiographically confirmed CAD in comparison to individuals without coronary atherosclerosis.
An increase in dietary fiber intake has the potential to influence plasma lipid components, including LDL cholesterol, HDL cholesterol, and triglycerides. Furthermore, dietary fiber has the potential to influence the composition of the gut microbiota, which may, in turn, influence the levels of LBP and other microbially produced factors, and consequently, cardiovascular health. It has been demonstrated that dietary fiber can facilitate the growth of a more diverse gut microbiota, which in turn produces metabolites that are capable of modulating local and systemic inflammation. Moreover, the impact of a diet rich in fiber on the structure and function of the gut microbiota and the metabolites produced by this microbial community may prove effective in preventing certain CVDs by reducing local and systemic inflammation.
Dietary fiber is metabolized by intestinal bacteria, resulting in the production of metabolites that are subsequently absorbed by intestinal cells. Short-chain fatty acids (SCFAs), including acetate, propionate, and butyrate, are produced by the intestinal microbiota in the large intestine through fermentation of dietary fiber. Research has demonstrated that they function as ligands for a particular group of G protein-coupled receptors, including GPR43 and GPR109A, which are expressed on a range of cells, including white blood cells. The binding of SCFAs to these receptors results in the induction of intracellular signaling, which in turn triggers a wide range of cellular and tissue effects that may be involved in the regulation of metabolism and inflammation. These effects may contribute to the cardioprotective effects of SCFAs.
The present study will investigate the effect of oat bran supplementation on plasma lipid, insulin, inflammatory markers, LBP concentrations, selected fecal bacteria, and short-chain fatty acids receptors gene expression in peripheral blood mononuclear cells in patients with coronary artery disease.
This study employs a randomized controlled clinical trial design without blinding. In this study, patients meeting the eligibility criteria and referred to the Shahid Modarres Medical and Research Center will be selected. The objectives and methodology of the study will be fully explained to them, and written consent will be obtained from all volunteers. The medical records of the patients will be utilized to collate data pertaining to the disease, the pharmacological agents employed, and other pertinent medical information. The study will include measurements of weight and calculation of body mass index (BMI) for all patients at the outset and conclusion of the study. The level of physical activity will be gauged using a physical activity questionnaire at the outset and conclusion of the study. Patients will be randomly assigned to one of two study groups, namely the control group and the oat bran group. The study will be conducted over a period of two months. The control group will receive general dietary advice, including recommendations to reduce saturated fat, sodium, and simple sugar intake. In the oat bran group, in addition to the aforementioned recommendations, patients will consume 28 grams of oat bran per day. All patients will be instructed to refrain from using over-the-counter herbal medicines, probiotic food products (such as yogurt), and probiotic supplements throughout the course of the study.
To assess biochemical blood parameters at the outset and conclusion of the study, a 6 cc venous blood sample will be obtained from all patients via the brachial vein after 12-14 hours of fasting by a laboratory technician. Following the collection of the blood samples, the plasma will be separated from the blood cells, which will then be separated from one another using a Ficoll solution. The plasma and PBMC samples will be stored in microtubes in a freezer at -80°C until the requisite tests have been conducted. The concentrations of plasma lipids will be determined using standard kits. LBP concentrations will be quantified using enzyme-linked immunosorbent assay (ELISA) kits. Total RNA will be extracted from the PBMC samples and cDNA will be synthesized using a cDNA synthesis kit. Subsequently, the expression of the GPR109A and GPR43 genes will be quantified through the use of specific primers and a quantitative PCR assay.
- Conditions
- Coronary Arterial Disease (CAD)
- Being tested
- Oat bran group, Control (Standard treatment)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oat bran groupOther
Patients consume 28 grams of oat bran daily for two months in addition to their usual medical treatment.
Control (Standard treatment)Other
Patients receive standard medical treatment.
| Study group | Role | What they receive |
|---|---|---|
| Oat bran | Experimental | Daily consumption of oat bran along with standard medical treatment Receives: Other: Oat bran group |
| Control | Other | Standard medical treatment Receives: Other: Control (Standard treatment) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma lipids
Plasma concentrations of triglyceride, cholesterol, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol
Measured: At the beginning of the study and two months later
Plasma inflammatory biomarkers
Plasma c-reactive protein, Interleukin-6, ICAM-1, and VCAM-1
Measured: At the beginning of the study and two months later
Plasma lipopolysaccharide-binding protein
Plasma concentrations of lipopolysaccharide-binding protein
Measured: At the beginning of the study and two months later
Secondary outcomes (2)
Fecal bacteria
Relative abundance of certain bacteria in feces
Measured: At the beginning of the study and two months later
Expression of GPR43 and GPR109A
The expression of the GPR109A and GPR43 genes in peripheral blood mononuclear cells
Measured: At the beginning of the study and two months later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2024
- Study start20 May 2025
- Primary completion18 Dec 2025
- Study completion24 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Arterial Disease (CAD)Studies 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
- Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shahid Beheshti University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Javad Nasrollahzadeh, Shahid Beheshti University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06747234
- Sponsor's protocol ID
- 43012538
- Status last verified
- May 2025
- First submitted
- 18 Dec 2024
- Last updated
- 24 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Oat Bran Supplementation on Plasma Lipid, Selected Fecal Bacteria, and Short-chain Fatty Acids Receptors Gene Expression in Peripheral Blood Mononuclear Cells in Patients With Coronary Artery Disease
- ClinicalTrials.gov ID
- NCT06747234
- Acronym / sponsor ID
- 43012538
- Conditions
- Coronary Arterial Disease (CAD)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Shahid Beheshti University of Medical SciencesUniversity, hospital or other
- Study start
- 20 May 2025 (actual)
- Primary completion
- 18 Dec 2025 (actual)
- Study completion
- 24 Dec 2025 (actual)
- First posted
- 24 Dec 2024 (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 development of atherosclerosis is significantly influenced by the interplay between lipid and inflammatory factors. Endotoxemia, defined as the presence of endotoxins, particularly lipopolysaccharides (LPS) derived from Gram-negative bacteria, in the bloodstream, is closely associated with low-grade inflammation. This chronic, systemic inflammatory response does not reach the severity of acute inflammation but can contribute to the development of atherosclerosis and cardiovascular disease (CVD). Lipopolysaccharide-binding protein (LBP) is a soluble acute-phase protein that binds to bacterial LPS. Elevated levels of LBP have been linked to increased low-grade inflammation, which further exacerbates chronic inflammation and metabolic dysregulation. Dietary fiber, such as oat bran, may have a role in mitigating the effects of endotoxemia and its associated inflammation. Furthermore, dietary fiber could play a role in improving plasma lipid profiles. The present study will investigate the effect of oat bran supplementation on cardiometabolic risk markers, LBP concentrations, selected fecal bacteria, and short-chain fatty acids receptors gene expression in peripheral blood mononuclear cells in patients with coronary artery disease.
Detailed description
As stated by the World Health Organization, cardiovascular diseases (CVDs), particularly coronary artery disease (CAD), represent the primary cause of mortality globally. Atherosclerosis, the primary pathophysiological mechanism underlying CAD, is a multifactorial process, with lipids and inflammatory factors playing a pivotal role. One potential cause of chronic inflammation is endotoxemia, which is a condition resulting from the absorption of lipopolysaccharide (LPS) into the circulatory system. LPS is an active component of the cell wall of gram-negative bacteria derived from the gut microbiota and a potent activator of the innate immune system via the toll-like receptor 4 pathway. The entry of LPS into the systemic circulation ultimately results in the intracellular transcription of several inflammatory mediators, which subsequently trigger an inflammatory response. This is recognized as a contributing factor in the development and progression of atherosclerosis and subsequent coronary artery disease. The presence of bacterial 16S ribosomal RNA belonging to the Enterobacterial family has been identified in atherosclerotic plaques. The protein that binds to LPS in the blood is known as LBP (lipopolysaccharide-binding protein). Serum levels of LBP have been demonstrated to be elevated in patients with angiographically confirmed CAD in comparison to individuals without coronary atherosclerosis.
An increase in dietary fiber intake has the potential to influence plasma lipid components, including LDL cholesterol, HDL cholesterol, and triglycerides. Furthermore, dietary fiber has the potential to influence the composition of the gut microbiota, which may, in turn, influence the levels of LBP and other microbially produced factors, and consequently, cardiovascular health. It has been demonstrated that dietary fiber can facilitate the growth of a more diverse gut microbiota, which in turn produces metabolites that are capable of modulating local and systemic inflammation. Moreover, the impact of a diet rich in fiber on the structure and function of the gut microbiota and the metabolites produced by this microbial community may prove effective in preventing certain CVDs by reducing local and systemic inflammation.
Dietary fiber is metabolized by intestinal bacteria, resulting in the production of metabolites that are subsequently absorbed by intestinal cells. Short-chain fatty acids (SCFAs), including acetate, propionate, and butyrate, are produced by the intestinal microbiota in the large intestine through fermentation of dietary fiber. Research has demonstrated that they function as ligands for a particular group of G protein-coupled receptors, including GPR43 and GPR109A, which are expressed on a range of cells, including white blood cells. The binding of SCFAs to these receptors results in the induction of intracellular signaling, which in turn triggers a wide range of cellular and tissue effects that may be involved in the regulation of metabolism and inflammation. These effects may contribute to the cardioprotective effects of SCFAs.
The present study will investigate the effect of oat bran supplementation on plasma lipid, insulin, inflammatory markers, LBP concentrations, selected fecal bacteria, and short-chain fatty acids receptors gene expression in peripheral blood mononuclear cells in patients with coronary artery disease.
This study employs a randomized controlled clinical trial design without blinding. In this study, patients meeting the eligibility criteria and referred to the Shahid Modarres Medical and Research Center will be selected. The objectives and methodology of the study will be fully explained to them, and written consent will be obtained from all volunteers. The medical records of the patients will be utilized to collate data pertaining to the disease, the pharmacological agents employed, and other pertinent medical information. The study will include measurements of weight and calculation of body mass index (BMI) for all patients at the outset and conclusion of the study. The level of physical activity will be gauged using a physical activity questionnaire at the outset and conclusion of the study. Patients will be randomly assigned to one of two study groups, namely the control group and the oat bran group. The study will be conducted over a period of two months. The control group will receive general dietary advice, including recommendations to reduce saturated fat, sodium, and simple sugar intake. In the oat bran group, in addition to the aforementioned recommendations, patients will consume 28 grams of oat bran per day. All patients will be instructed to refrain from using over-the-counter herbal medicines, probiotic food products (such as yogurt), and probiotic supplements throughout the course of the study.
To assess biochemical blood parameters at the outset and conclusion of the study, a 6 cc venous blood sample will be obtained from all patients via the brachial vein after 12-14 hours of fasting by a laboratory technician. Following the collection of the blood samples, the plasma will be separated from the blood cells, which will then be separated from one another using a Ficoll solution. The plasma and PBMC samples will be stored in microtubes in a freezer at -80°C until the requisite tests have been conducted. The concentrations of plasma lipids will be determined using standard kits. LBP concentrations will be quantified using enzyme-linked immunosorbent assay (ELISA) kits. Total RNA will be extracted from the PBMC samples and cDNA will be synthesized using a cDNA synthesis kit. Subsequently, the expression of the GPR109A and GPR43 genes will be quantified through the use of specific primers and a quantitative PCR assay.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oat bran | Experimental | Other: Oat bran groupDaily consumption of oat bran along with standard medical treatment |
| Control | Other | Other: Control (Standard treatment)Standard medical treatment |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with a history of coronary heart disease who have recently undergone coronary angioplasty
Key exclusion criteria (5 listed)
- End-stage renal disease
- Inflammatory bowel syndrome (IBD),
- Recent glucocorticoid or antibiotic treatment,
- Cancer undergoing chemotherapy or radiotherapy,
- Any alteration to the treatment plan, including changes in drug type or surgical intervention
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 |
|---|---|---|
| Oat bran groupPatients consume 28 grams of oat bran daily for two months in addition to their usual medical treatment. | Other | Oat bran |
| Control (Standard treatment)Patients receive standard medical treatment. | Other | Control |
Primary outcome
Plasma lipids
Time frame: At the beginning of the study and two months later
Plasma concentrations of triglyceride, cholesterol, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol
Plasma inflammatory biomarkers
Time frame: At the beginning of the study and two months later
Plasma c-reactive protein, Interleukin-6, ICAM-1, and VCAM-1
Plasma lipopolysaccharide-binding protein
Time frame: At the beginning of the study and two months later
Plasma concentrations of lipopolysaccharide-binding protein
2 secondary outcomes
Fecal bacteria
Time frame: At the beginning of the study and two months later
Expression of GPR43 and GPR109A
Time frame: At the beginning of the study and two months later
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 24 Feb 2026.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oat bran group in people with Coronary Arterial Disease (CAD), run by Shahid Beheshti University of Medical Sciences at 2 sites in Iran.
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 1 inclusion and 5 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 24 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Iran. 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. 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?
Plasma lipids (time frame: At the beginning of the study and two months later). The study lists 3 primary outcomes in all. 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 24 Feb 2026; AzTrials last refreshed its copy on 8 Nov 2026.