Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT05995002 |
| Other study ID # |
43004233 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
August 21, 2023 |
| Est. completion date |
June 27, 2024 |
Study information
| Verified date |
March 2024 |
| Source |
Shahid Beheshti University |
| Contact |
Javad Nasrollahzadeh, PhD |
| Phone |
+98212277424 |
| Email |
jnasrollahzadeh[@]gmail.com |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
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.
Description:
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,
