Coronary Artery DiseaseNCT03392025
Flaxseed Consumption, Alone and in Combination With the Mediterranean-like Diet, on Some Indicators Related to Atherosclerosis
A study testing Flaxseed and the Mediterranean-like diet in people with Coronary Artery Disease, run by Javad Nasrollahzadeh at 1 site in Iran.
Trial summary
Flaxseed consumption has beneficial effects on cardiovascular risk factors. In addition, the benefit of the Mediterranean-like diet in primary and secondary prevention of cardiovascular diseases has been shown.The purpose of this study is to investigate the effects of flaxseed consumption, alone and in combination… Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Flaxseed and the Mediterranean-like diet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 87 participants
- Where
- 1 siteIran
- Study dates
- 1 Sep 2017to 1 Sep 2018
- 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 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- coronary artery disease patients (more than 50% blockage in coronary arteries) needed angioplasty with stent
- willing to participation in the study
Who cannot join
- cigarette Smoking
- continuous consumption of any antioxidant supplement such as vitamin E, vitamin C and Selenium in last month
- consumption of flaxseed or any omega-3 supplement at the beginning of the study
- َadvanced renal disease
- unwillingness to continuance
- any change in disease treatment plan such as change in type and dose of lipid lowering drugs or surgical operation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Flaxseed Consumption, Alone and in Combination With the Mediterranean-like Diet, on Vascular Endothelial Function and Some Biochemical Indicators Related to Atherosclerosis in Patients With Coronary Artery Disease
Flaxseed consumption has beneficial effects on cardiovascular risk factors. In addition, the benefit of the Mediterranean-like diet in primary and secondary prevention of cardiovascular diseases has been shown.The purpose of this study is to investigate the effects of flaxseed consumption, alone and in combination with the Mediterranean-like diet, in adjunct to conventional medical treatment, in improving vascular endothelial function, plasma lipid profile and high sensitivity c-reactive protein of coronary artery disease (CAD) patients.
Read the detailed description
A randomized placebo 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 81 eligible coronary artery disease patients, aged 20-75 years. Intervention groups will be received 30 g/d flaxseed, alone, or with weekly Mediterranean-like diet menu and control group will be received capsules of wheat fiber as placebo for 3 months. Vascular endothelial function will be evaluated through measurement of flow mediated dilatation (FMD) in brachial artery and carotid intima-media thickness (c-IMT) via ultrasound sonography and plasma level of asymmetric di-methyl arginine (ADMA). Fasting blood sample will be taken to measure malondialdehyde (MDA), lipid profile, high sensitive C-reactive protein and inflammatory cytokines (Interleukine-6 [IL-6] and Tumor Necrosis Factor-a [TNF-a]).
- Conditions
- Coronary Artery Disease
- Being tested
- Flaxseed, the Mediterranean-like diet, Placebo
- 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.
FlaxseedOther
Daily consumption of 30 grams flaxseed in adjunct to medical treatment for 3 months
the Mediterranean-like dietOther
Weekly Mediterranean-like diet menu in adjunct to medical treatment for 3 months
PlaceboDietary supplement
Daily consumption of one capsule of wheat fiber as placebo in adjunct to medical treatment for 3 months
| Study group | Role | What they receive |
|---|---|---|
| Flaxseed | Active comparator | Daily consumption of 30 grams flaxseed for 3 months Receives: Other: Flaxseed |
| Flaxseed and the Mediterranean-like diet | Active comparator | Daily consumption of 30 grams flaxseed in adjunct to the Mediterranean-like diet for 3 months Receives: Other: Flaxseed; Other: the Mediterranean-like diet |
| Placebo | Placebo comparator | Daily consumption of Placebo for 3 months Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Flow Mediated Dilatation (FMD)
Change in dilatation of the brachial artery from baseline at 3 month
Measured: 3 month
Secondary outcomes (4)
plasma level of high sensitive C reactive protein (hs-CRP)
change in plasma level of high sensitive C reactive protein (hs-CRP) from baseline at 3 month
Measured: 3 month
plasma lipid profile
change in plasma level of lipid profile from baseline at 3 month
Measured: 3 month
carotid intima-media thickness (c-IMT)
change in carotid intima-media thickness from baseline at 3 month
Measured: 3 month
asymmetric di-methyl arginine (ADMA)
change in plasma level of assymetric di-methyl arginine from baseline at 3 month
Measured: 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2018
- Study start1 Sep 2017
- Primary completion1 May 2018
- Study completion1 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)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
- 87 participants (actual)
Sponsor and investigators
- Lead sponsor
- Javad Nasrollahzadeh
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Javad Nasrollahzadeh, Shahid Beheshti University
- Investigators
- Javad Nasrollahzadeh, Ph.D, Study chair, Department of Clinical Nutrition and Diet Therapy, National Nutrition and Food Technology Research Institute, Faculty of Nutrition Sciences and Food Technology, Shahid Beheshti University of Medical SciencesJavad Nasrollahzadeh, Ph.D, Study director, Department of Clinical Nutrition and Diet Therapy, National Nutrition and Food Technology Research Institute, Faculty of Nutrition Sciences and Food Technology, Shahid Beheshti University of Medical SciencesNafiseh Khandouzi, Ph.D student, Principal investigator, Department of Clinical Nutrition and Diet Therapy, National Nutrition and Food Technology Research Institute, Faculty of Nutrition Sciences and Food Technology, Shahid Beheshti University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03392025
- Sponsor's protocol ID
- 651
- Status last verified
- Sep 2018
- First submitted
- 7 Dec 2017
- Last updated
- 7 Sep 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Cassani RS, Fassini PG, Silvah JH, Lima CM, Marchini JS. Retraction Note: Impact of weight loss diet associated with flaxseed on inflammatory markers in men with cardiovascular risk factors: a clinical study. Nutr J. 2016 Jun 7;15(1):59. doi: 10.1186/s12937-016-0165-x. No abstract available.
PubMed 27267967Widmer RJ, Flammer AJ, Lerman LO, Lerman A. The Mediterranean diet, its components, and cardiovascular disease. Am J Med. 2015 Mar;128(3):229-38. doi: 10.1016/j.amjmed.2014.10.014. Epub 2014 Oct 15.
PubMed 25447615Ros E, Martinez-Gonzalez MA, Estruch R, Salas-Salvado J, Fito M, Martinez JA, Corella D. Mediterranean diet and cardiovascular health: Teachings of the PREDIMED study. Adv Nutr. 2014 May 14;5(3):330S-6S. doi: 10.3945/an.113.005389. Print 2014 May.
PubMed 24829485Bloedon 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 18460483Fuentes F, Lopez-Miranda J, Sanchez E, Sanchez F, Paez J, Paz-Rojas E, Marin C, Gomez P, Jimenez-Pereperez J, Ordovas JM, Perez-Jimenez F. Mediterranean and low-fat diets improve endothelial function in hypercholesterolemic men. Ann Intern Med. 2001 Jun 19;134(12):1115-9. doi: 10.7326/0003-4819-134-12-200106190-00011.
PubMed 11412051Estruch R, Martinez-Gonzalez MA, Corella D, Salas-Salvado J, Ruiz-Gutierrez V, Covas MI, Fiol M, Gomez-Gracia E, Lopez-Sabater MC, Vinyoles E, Aros F, Conde M, Lahoz C, Lapetra J, Saez G, Ros E; PREDIMED Study Investigators. Effects of a Mediterranean-style diet on cardiovascular risk factors: a randomized trial. Ann Intern Med. 2006 Jul 4;145(1):1-11. doi: 10.7326/0003-4819-145-1-200607040-00004.
PubMed 16818923Murie-Fernandez M, Irimia P, Toledo E, Martinez-Vila E, Buil-Cosiales P, Serrano-Martinez M, Ruiz-Gutierrez V, Ros E, Estruch R, Martinez-Gonzalez MA; PREDIMED Investigators. Carotid intima-media thickness changes with Mediterranean diet: a randomized trial (PREDIMED-Navarra). Atherosclerosis. 2011 Nov;219(1):158-62. doi: 10.1016/j.atherosclerosis.2011.06.050. Epub 2011 Jul 6.
PubMed 21802081Marin C, Ramirez R, Delgado-Lista J, Yubero-Serrano EM, Perez-Martinez P, Carracedo J, Garcia-Rios A, Rodriguez F, Gutierrez-Mariscal FM, Gomez P, Perez-Jimenez F, Lopez-Miranda J. Mediterranean diet reduces endothelial damage and improves the regenerative capacity of endothelium. Am J Clin Nutr. 2011 Feb;93(2):267-74. doi: 10.3945/ajcn.110.006866. Epub 2010 Dec 1.
PubMed 21123460
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Flaxseed Consumption, Alone and in Combination With the Mediterranean-like Diet, on Vascular Endothelial Function and Some Biochemical Indicators Related to Atherosclerosis in Patients With Coronary Artery Disease
- ClinicalTrials.gov ID
- NCT03392025
- Acronym / sponsor ID
- 651
- Conditions
- Coronary Artery Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 87 participants (actual)
- Lead sponsor
- Javad NasrollahzadehUniversity, hospital or other
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 1 May 2018 (actual)
- Study completion
- 1 Sep 2018 (actual)
- First posted
- 5 Jan 2018 (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 consumption has beneficial effects on cardiovascular risk factors. In addition, the benefit of the Mediterranean-like diet in primary and secondary prevention of cardiovascular diseases has been shown.The purpose of this study is to investigate the effects of flaxseed consumption, alone and in combination with the Mediterranean-like diet, in adjunct to conventional medical treatment, in improving vascular endothelial function, plasma lipid profile and high sensitivity c-reactive protein of coronary artery disease (CAD) patients.
Detailed description
A randomized placebo 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 81 eligible coronary artery disease patients, aged 20-75 years. Intervention groups will be received 30 g/d flaxseed, alone, or with weekly Mediterranean-like diet menu and control group will be received capsules of wheat fiber as placebo for 3 months. Vascular endothelial function will be evaluated through measurement of flow mediated dilatation (FMD) in brachial artery and carotid intima-media thickness (c-IMT) via ultrasound sonography and plasma level of asymmetric di-methyl arginine (ADMA). Fasting blood sample will be taken to measure malondialdehyde (MDA), lipid profile, high sensitive C-reactive protein and inflammatory cytokines (Interleukine-6 [IL-6] and Tumor Necrosis Factor-a [TNF-a]).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Flaxseed | Active comparator | Other: FlaxseedDaily consumption of 30 grams flaxseed for 3 months |
| Flaxseed and the Mediterranean-like diet | Active comparator | Other: Flaxseed, Other: the Mediterranean-like dietDaily consumption of 30 grams flaxseed in adjunct to the Mediterranean-like diet for 3 months |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboDaily consumption of Placebo for 3 months |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- coronary artery disease patients (more than 50% blockage in coronary arteries) needed angioplasty with stent
- willing to participation in the study
Key exclusion criteria (6 listed)
- cigarette Smoking
- continuous consumption of any antioxidant supplement such as vitamin E, vitamin C and Selenium in last month
- consumption of flaxseed or any omega-3 supplement at the beginning of the study
- َadvanced renal disease
- unwillingness to continuance
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 |
|---|---|---|
| FlaxseedDaily consumption of 30 grams flaxseed in adjunct to medical treatment for 3 months | Other | Flaxseed, Flaxseed and the Mediterranean-like diet |
| the Mediterranean-like dietWeekly Mediterranean-like diet menu in adjunct to medical treatment for 3 months | Other | Flaxseed and the Mediterranean-like diet |
| PlaceboDaily consumption of one capsule of wheat fiber as placebo in adjunct to medical treatment for 3 months | Dietary supplement | Placebo |
Primary outcome
Flow Mediated Dilatation (FMD)
Time frame: 3 month
Change in dilatation of the brachial artery from baseline at 3 month
4 secondary outcomes
plasma level of high sensitive C reactive protein (hs-CRP)
Time frame: 3 month
plasma lipid profile
Time frame: 3 month
carotid intima-media thickness (c-IMT)
Time frame: 3 month
asymmetric di-methyl arginine (ADMA)
Time frame: 3 month
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 7 Sep 2018.
- Background: PubMed 27267967Cassani RS, Fassini PG, Silvah JH, Lima CM, Marchini JS. Retraction Note: Impact of weight loss diet associated with flaxseed on inflammatory markers in men with cardiovascular risk factors: a clinical study. Nutr J. 2016 Jun 7;15(1):59. doi: 10.1186/s12937-016-0165-x. No abstract available.
- Background: PubMed 25447615Widmer RJ, Flammer AJ, Lerman LO, Lerman A. The Mediterranean diet, its components, and cardiovascular disease. Am J Med. 2015 Mar;128(3):229-38. doi: 10.1016/j.amjmed.2014.10.014. Epub 2014 Oct 15.
- Background: PubMed 24829485Ros E, Martinez-Gonzalez MA, Estruch R, Salas-Salvado J, Fito M, Martinez JA, Corella D. Mediterranean diet and cardiovascular health: Teachings of the PREDIMED study. Adv Nutr. 2014 May 14;5(3):330S-6S. doi: 10.3945/an.113.005389. Print 2014 May.
- 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.
- Background: PubMed 11412051Fuentes F, Lopez-Miranda J, Sanchez E, Sanchez F, Paez J, Paz-Rojas E, Marin C, Gomez P, Jimenez-Pereperez J, Ordovas JM, Perez-Jimenez F. Mediterranean and low-fat diets improve endothelial function in hypercholesterolemic men. Ann Intern Med. 2001 Jun 19;134(12):1115-9. doi: 10.7326/0003-4819-134-12-200106190-00011.
- Background: PubMed 16818923Estruch R, Martinez-Gonzalez MA, Corella D, Salas-Salvado J, Ruiz-Gutierrez V, Covas MI, Fiol M, Gomez-Gracia E, Lopez-Sabater MC, Vinyoles E, Aros F, Conde M, Lahoz C, Lapetra J, Saez G, Ros E; PREDIMED Study Investigators. Effects of a Mediterranean-style diet on cardiovascular risk factors: a randomized trial. Ann Intern Med. 2006 Jul 4;145(1):1-11. doi: 10.7326/0003-4819-145-1-200607040-00004.
- Background: PubMed 21802081Murie-Fernandez M, Irimia P, Toledo E, Martinez-Vila E, Buil-Cosiales P, Serrano-Martinez M, Ruiz-Gutierrez V, Ros E, Estruch R, Martinez-Gonzalez MA; PREDIMED Investigators. Carotid intima-media thickness changes with Mediterranean diet: a randomized trial (PREDIMED-Navarra). Atherosclerosis. 2011 Nov;219(1):158-62. doi: 10.1016/j.atherosclerosis.2011.06.050. Epub 2011 Jul 6.
- Background: PubMed 21123460Marin C, Ramirez R, Delgado-Lista J, Yubero-Serrano EM, Perez-Martinez P, Carracedo J, Garcia-Rios A, Rodriguez F, Gutierrez-Mariscal FM, Gomez P, Perez-Jimenez F, Lopez-Miranda J. Mediterranean diet reduces endothelial damage and improves the regenerative capacity of endothelium. Am J Clin Nutr. 2011 Feb;93(2):267-74. doi: 10.3945/ajcn.110.006866. Epub 2010 Dec 1.
- 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.
Javad Nasrollahzadeh, Ph.D study chair
Department of Clinical Nutrition and Diet Therapy, National Nutrition and Food Technology Research Institute, Faculty of Nutrition Sciences and Food Technology, Shahid Beheshti University of Medical Sciences
Javad Nasrollahzadeh, Ph.D study director
Department of Clinical Nutrition and Diet Therapy, National Nutrition and Food Technology Research Institute, Faculty of Nutrition Sciences and Food Technology, Shahid Beheshti University of Medical Sciences
Nafiseh Khandouzi, Ph.D student principal investigator
Department of Clinical Nutrition and Diet Therapy, National Nutrition and Food Technology Research Institute, Faculty of Nutrition Sciences and Food Technology, 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 Flaxseed and the Mediterranean-like diet in people with Coronary Artery Disease, run by Javad Nasrollahzadeh 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 2 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 7 Sep 2018. 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 Dilatation (FMD) (time frame: 3 month). 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 NCT03392025, which also lists 8 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 7 Sep 2018.