An interventional study of Anthocyanin-rich diet in Coronary Artery Stenosis, sponsored by Shahid Beheshti University. Completed at 1 site in Iran. Open to participants aged 30 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-05-06.
Sponsored by Shahid Beheshti University · Not applicable, Interventional, and Prevention
Flavonoids are one of the main groups of polyphenols. Anthocyanins, which are a subgroup of the flavonoid family, are found in a number of fruits and some vegetables. In epidemiological studies, high dietary intake of polyphenols has been associated with improvement of some cardiometabolic risk factors in high-risk individuals. Furthermore, in controlled studies, consumption of polyphenol-rich food sources or anthocyanin extract supplementation has improved some cardiometabolic factors. In the present study, the effect of diet enriched with anthocyanin-rich food sources on cardiometabolic factors will be studied in coronary artery disease patients.
This study is an unblinded randomized controlled clinical trial. In this study, among the patients referred to Shahid Modares Hospital (Tehran, IRAN), those who are willing to participate and have inclusion criteria will be recruited. Inclusion criteria are coronary heart disease with recent coronary angiography, age range of 30-75 years. Exclusion criteria are end-stage renal disease, patients undergoing chemotherapy or radiotherapy, patients with inflammatory bowel syndrome, patients being treated with glucocorticoid drugs or antibiotics. Patients are randomly assigned to one of two study groups, including the control group and the group consuming food sources rich in anthocyanin in the diet. The duration of the study will be 8 weeks. In the control group, a general recommendation related to a healthy diet such as reducing the intake of saturated fats, sodium, and simple sugars, is provided. In the anthocyanin-rich diet group, the weekly food plan aims to increase the consumption of anthocyanin-rich sources such as berries, black grapes (or currants), cherries, strawberries, pomegranates, and red onions. The patients' drug regimen will not change during the study. Patients are asked not to use over-the-counter herbal medicines and nutritional supplements during the study. At the beginning and end of the study, blood,
309 studies on the registry are indexed under Coronary Stenosis; 64 are open to participants now.
This study's enrollment of 62 is below the median of 191 across 165 interventional studies indexed under Coronary Stenosis.
Browse Coronary Stenosis studies →Shahid Beheshti University is the lead sponsor of 37 studies on the registry; 3 are open to participants now.
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Exclusion Criteria:
Conventional drug treatment with a general recommendation for a healthy diet.
Conventional drug treatment with a weekly food plan aims to increase the consumption of anthocyanin-rich sources
Other: Anthocyanin-rich diet
A weekly food plan aims to increase the consumption of anthocyanin-rich sources such as berries, black grapes (or currants), cherries, strawberries, pomegranates, and red onions.
Plasma inflammatory factors concentration
fasting plasma concentration of C-reactive protein and IL-6
Time frame: 8 weeks
Plasma concentration of insulin
Fasting plasma concentration of insulin
Time frame: 8 weeks
Plasma levels of lipids and lipoproteins
Fasting plasma levels of triglycerides, HDL-cholesterol, and LDL-cholesterol
Time frame: 8 weeks
Plan to share: No
Ran from Aug 2023 to primary completion in Nov 2024, 14 months.
Of 47 non-industry interventional studies with no phase under Coronary Stenosis, half reached primary completion within 44 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 66. This study's 14 months is below that.
Counting every sponsor, half of 69 studies reached it within 26 months; a quarter within 14 and three quarters within 57.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.
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Shahid Beheshti University