Coronary Artery DiseaseNCT04767230
The Effect of a Healthy Diet Containing Flaxseed and Olive Oil on Cardiovascular Disease Risk Markers
A study testing Dietary Intervention in people with Coronary Artery Disease, run by Shahid Beheshti University of Medical Sciences at 1 site in Iran.
Trial summary
Flaxseed and olive oil consumption have beneficial effects on cardiovascular risk factors. Nonetheless the effects of their simultaneous consumption have not yet been studied.The purpose of this study is to investigate the effects of a healthy diet containing flaxseed and olive oil compared with healthy dietary advice… Read more about this study
- Who is it for?
- Ages 30 to 75 years
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Dietary Intervention
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteIran
- Study dates
- 1 Mar 2021to 3 Mar 2022
- 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 30 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Established coronary artery disease as verified by coronary angiography
- Body ass index <30 kg/m2
- men and postmenopausal women
- Willing to participate in the study
Who cannot join
- Unwilling to follow the protocol and/or give informed consent
- Chronic Kidney Disease stage 4 or 5 or a reported history cancer
- Regular consumption of flaxseed or omega-3 supplements during previous month
- Any changes in the disease treatment plan including type or dose of lipid-lowering medications or coronary artery bypass graft during the study period
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of a Healthy Diet Containing Flaxseed and Olive Oil Compared With Healthy Dietary Advice on Cardiovascular Disease Risk Markers in Patients With Coronary Artery Disease
Flaxseed and olive oil consumption have beneficial effects on cardiovascular risk factors. Nonetheless the effects of their simultaneous consumption have not yet been studied.The purpose of this study is to investigate the effects of a healthy diet containing flaxseed and olive oil compared with healthy dietary advice on cardiovascular disease risk markers in patients with coronary artery disease (CAD), in improving flow-mediated dilation, plasma lipid profile and fatty acids composition of red blood cells.
Read the detailed description
A randomized controlled clinical trial will be conducted in Rajaie Cardiovascular Center in Tehran, Iran. After review of the inclusion and exclusion criteria and explanation of the design of the study, written consent form will be completed. The participants are 50 eligible coronary artery disease patients, aged 30-75 years. Intervention group will be received a heart-healthy diet with a specified number of food servings from different food groups (including vegetables, fruits, grains, dairy products, meats) + daily consumption of 30 grams of flaxseed + 25 mL/day of refined olive oil (equivalent to 4 tablespoons; 2 tablespoons for lunch and 2 tablespoons for dinner); and control group will be received recommendations for a heart-healthy diet, such as those of the American Heart Association for 3 months. These include eating at least 5 servings of vegetables and fruits daily, reduction in the consumption of sources of saturated and trans fats by avoiding the consumption of high-fat red meats and replacing them with low-fat meat or with poultry and fish, replacing low-fat dairy sources with regular or high-fat ones; consumption of regular vegetable oils such as canola and sunflower; reduction in salt consumption; and reduction in the consumption of simple sugars, for 3 months. Flow mediated dilatation (FMD) in brachial artery via ultrasonography, plasma levels of lipids and lipoproteins via enzymatic method, and fatty acids composition of red blood cells via gas chromatography method were measured.
- Conditions
- Coronary Artery Disease
- Being tested
- Dietary Intervention
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary InterventionOther
A heart-healthy diet + daily consumption of 30 grams of flaxseed + 25 mL/day of refined olive oil in adjunct to medical treatment for 3 months
| Study group | Role | What they receive |
|---|---|---|
| A heart-healthy diet + Flaxseed + Olive oil | Active comparator | A heart-healthy diet with a specified number of food servings from different food groups (including vegetables, fruits, grains, dairy products, meats) + daily consumption of 30 grams of flaxseed + 25 mL/day of refined olive oil (equivalent to 4 tablespoons; 2 tablespoons for lunch and 2 tablespoons for dinner) for 3 months Receives: Other: Dietary Intervention |
| A heart-healthy diet | Placebo comparator | Recommendations for a heart-healthy diet, such as those of the American Heart Association for 3 months. These include eating at least 5 servings of vegetables and fruits daily, reduction in the consumption of sources of saturated and trans fats by avoiding the consumption of high-fat red meats and replacing them with low-fat meat or with poultry and fish, replacing low-fat dairy sources with regular or high-fat ones; consumption of regular vegetable oils such as canola and sunflower; reduction in salt consumption; and reduction in the consumption of simple sugars for 3 months Receives: Other: Dietary Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Flow Mediated Dilation (FMD) in brachial artery
Measurement of dilation of the brachial artery by ultrasonography from baseline to 3 months later
Measured: 3 months
Secondary outcomes (2)
Plasma lipid profile (total cholesterol, LDL-C, HDL-C, triglyceride)
Measurement of plasma level of lipid profile by enzymatic method from baseline to 3 months later
Measured: 3 months
Total fatty acids composition of red blood cells
Measurement of total fatty acids composition of red blood cells by gas chromatography from baseline to 3 months later
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2021
- Study start1 Mar 2021
- Primary completion30 Aug 2021
- Study completion3 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shahid Beheshti University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nafiseh Khandouzi, Shahid Beheshti University of Medical Sciences
- Investigators
- Javad Nasrollahzadeh, Ph.D, Study director, Shahid Beheshti University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04767230
- Sponsor's protocol ID
- 25672
- Status last verified
- Mar 2022
- First submitted
- 20 Feb 2021
- Last updated
- 4 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Edel AL, Rodriguez-Leyva D, Maddaford TG, Caligiuri SP, Austria JA, Weighell W, Guzman R, Aliani M, Pierce GN. Dietary flaxseed independently lowers circulating cholesterol and lowers it beyond the effects of cholesterol-lowering medications alone in patients with peripheral artery disease. J Nutr. 2015 Apr;145(4):749-57. doi: 10.3945/jn.114.204594. Epub 2015 Feb 18.
PubMed 25694068Khandouzi N, Zahedmehr A, Mohammadzadeh A, Sanati HR, Nasrollahzadeh J. Effect of flaxseed consumption on flow-mediated dilation and inflammatory biomarkers in patients with coronary artery disease: a randomized controlled trial. Eur J Clin Nutr. 2019 Feb;73(2):258-265. doi: 10.1038/s41430-018-0268-x. Epub 2018 Aug 20.
PubMed 30127374Mandasescu S, Mocanu V, Dascalita AM, Haliga R, Nestian I, Stitt PA, Luca V. Flaxseed supplementation in hyperlipidemic patients. Rev Med Chir Soc Med Nat Iasi. 2005 Jul-Sep;109(3):502-6.
PubMed 16607740Bloedon LT, Balikai S, Chittams J, Cunnane SC, Berlin JA, Rader DJ, Szapary PO. Flaxseed and cardiovascular risk factors: results from a double blind, randomized, controlled clinical trial. J Am Coll Nutr. 2008 Feb;27(1):65-74. doi: 10.1080/07315724.2008.10719676.
PubMed 18460483
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of a Healthy Diet Containing Flaxseed and Olive Oil Compared With Healthy Dietary Advice on Cardiovascular Disease Risk Markers in Patients With Coronary Artery Disease
- ClinicalTrials.gov ID
- NCT04767230
- Acronym / sponsor ID
- 25672
- Conditions
- Coronary Artery Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Shahid Beheshti University of Medical SciencesUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 30 Aug 2021 (actual)
- Study completion
- 3 Mar 2022 (actual)
- First posted
- 23 Feb 2021 (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.
Flaxseed and olive oil consumption have beneficial effects on cardiovascular risk factors. Nonetheless the effects of their simultaneous consumption have not yet been studied.The purpose of this study is to investigate the effects of a healthy diet containing flaxseed and olive oil compared with healthy dietary advice on cardiovascular disease risk markers in patients with coronary artery disease (CAD), in improving flow-mediated dilation, plasma lipid profile and fatty acids composition of red blood cells.
Detailed description
A randomized controlled clinical trial will be conducted in Rajaie Cardiovascular Center in Tehran, Iran. After review of the inclusion and exclusion criteria and explanation of the design of the study, written consent form will be completed. The participants are 50 eligible coronary artery disease patients, aged 30-75 years. Intervention group will be received a heart-healthy diet with a specified number of food servings from different food groups (including vegetables, fruits, grains, dairy products, meats) + daily consumption of 30 grams of flaxseed + 25 mL/day of refined olive oil (equivalent to 4 tablespoons; 2 tablespoons for lunch and 2 tablespoons for dinner); and control group will be received recommendations for a heart-healthy diet, such as those of the American Heart Association for 3 months. These include eating at least 5 servings of vegetables and fruits daily, reduction in the consumption of sources of saturated and trans fats by avoiding the consumption of high-fat red meats and replacing them with low-fat meat or with poultry and fish, replacing low-fat dairy sources with regular or high-fat ones; consumption of regular vegetable oils such as canola and sunflower; reduction in salt consumption; and reduction in the consumption of simple sugars, for 3 months. Flow mediated dilatation (FMD) in brachial artery via ultrasonography, plasma levels of lipids and lipoproteins via enzymatic method, and fatty acids composition of red blood cells via gas chromatography method were measured.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A heart-healthy diet + Flaxseed + Olive oil | Active comparator | Other: Dietary InterventionA heart-healthy diet with a specified number of food servings from different food groups (including vegetables, fruits, grains, dairy products, meats) + daily consumption of 30 grams of flaxseed + 25 mL/day of refined olive oil (equivalent to 4 tablespoons; 2 tablespoons for lunch and 2 tablespoons for dinner) for 3 months |
| A heart-healthy diet | Placebo comparator | Other: Dietary InterventionRecommendations for a heart-healthy diet, such as those of the American Heart Association for 3 months. These include eating at least 5 servings of vegetables and fruits daily, reduction in the consumption of sources of saturated and trans fats by avoiding the consumption of high-fat red meats and replacing them with low-fat meat or with poultry and fish, replacing low-fat dairy sources with regular or high-fat ones; consumption of regular vegetable oils such as canola and sunflower; reduction in salt consumption; and reduction in the consumption of simple sugars for 3 months |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Established coronary artery disease as verified by coronary angiography
- Body ass index <30 kg/m2
- men and postmenopausal women
- Willing to participate in the study
Key exclusion criteria (4 listed)
- Unwilling to follow the protocol and/or give informed consent
- Chronic Kidney Disease stage 4 or 5 or a reported history cancer
- Regular consumption of flaxseed or omega-3 supplements during previous month
- Any changes in the disease treatment plan including type or dose of lipid-lowering medications or coronary artery bypass graft during the study period
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 |
|---|---|---|
| Dietary InterventionA heart-healthy diet + daily consumption of 30 grams of flaxseed + 25 mL/day of refined olive oil in adjunct to medical treatment for 3 months | Other | A heart-healthy diet, A heart-healthy diet + Flaxseed + Olive oil |
Primary outcome
Flow Mediated Dilation (FMD) in brachial artery
Time frame: 3 months
Measurement of dilation of the brachial artery by ultrasonography from baseline to 3 months later
2 secondary outcomes
Plasma lipid profile (total cholesterol, LDL-C, HDL-C, triglyceride)
Time frame: 3 months
Total fatty acids composition of red blood cells
Time frame: 3 months
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 4 Mar 2022.
- Background: PubMed 25694068Edel AL, Rodriguez-Leyva D, Maddaford TG, Caligiuri SP, Austria JA, Weighell W, Guzman R, Aliani M, Pierce GN. Dietary flaxseed independently lowers circulating cholesterol and lowers it beyond the effects of cholesterol-lowering medications alone in patients with peripheral artery disease. J Nutr. 2015 Apr;145(4):749-57. doi: 10.3945/jn.114.204594. Epub 2015 Feb 18.
- Background: PubMed 30127374Khandouzi N, Zahedmehr A, Mohammadzadeh A, Sanati HR, Nasrollahzadeh J. Effect of flaxseed consumption on flow-mediated dilation and inflammatory biomarkers in patients with coronary artery disease: a randomized controlled trial. Eur J Clin Nutr. 2019 Feb;73(2):258-265. doi: 10.1038/s41430-018-0268-x. Epub 2018 Aug 20.
- Background: PubMed 16607740Mandasescu S, Mocanu V, Dascalita AM, Haliga R, Nestian I, Stitt PA, Luca V. Flaxseed supplementation in hyperlipidemic patients. Rev Med Chir Soc Med Nat Iasi. 2005 Jul-Sep;109(3):502-6.
- Background: PubMed 18460483Bloedon LT, Balikai S, Chittams J, Cunnane SC, Berlin JA, Rader DJ, Szapary PO. Flaxseed and cardiovascular risk factors: results from a double blind, randomized, controlled clinical trial. J Am Coll Nutr. 2008 Feb;27(1):65-74. doi: 10.1080/07315724.2008.10719676.
- Individual participant dataSharing planned: No
Related trials for Coronary Artery Disease
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Active, not recruiting
Shockwave™ vs Surgical Endarterectomy for Calcified Severe Common Femoral Artery Stenosis: Comparison of Efficacy, Safety and Long-Term Outcomes
Common Femoral Artery Stenosis, Calcification; Heart
Not yet recruitingPhase 4
Roxadustat and Myocardial Injury After Off-Pump Coronary Artery Bypass Surgery
Coronary Artery Disease, Coronary Artery Bypass Grafting
RecruitingObservational study
Preoperative Gastric Ultrasound and Left Ventricular Function in Coronary Artery Bypass Surgery
Coronary Artery Disease, Left Ventricular Systolic Dysfunction
Active, not recruiting
The OCTOBER Trial - European Trial on Optical Coherence Tomography Optimized Bifurcation Event Reduction (OCTOBER)
Ischaemic Heart Disease, Ischemic Heart Disease
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.
Javad Nasrollahzadeh, Ph.D study director
Shahid Beheshti University of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dietary Intervention in people with Coronary Artery Disease, run by Shahid Beheshti University of Medical Sciences at 1 site 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 4 inclusion and 4 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 4 Mar 2022. 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 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. 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?
Flow Mediated Dilation (FMD) in brachial artery (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04767230, which also lists 4 linked publications.
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 4 Mar 2022.