Clinical trial NCT05995002: Anthocyanin Intake on Cardiometabolic Biomarkers
Official title: Effects of Increasing Anthocyanin Intake on Cardiometabolic Biomarkers in Patients With Coronary Artery Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Stenosis
Lead sponsor: Shahid Beheshti University
Sponsor class: OTHER
Collaborators: name: Shahid Beheshti University of Medical Sciences
First posted: 2023-08-16
Enrollment: 62
Sex: ALL
Minimum age (years): 30
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Detailed 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,

Eligibility criteria: Inclusion Criteria:

* coronary heart disease with recent coronary angiography

Exclusion Criteria:

* End-stage renal disease,
* Patients undergoing chemotherapy or radiotherapy,
* Patients with inflammatory bowel syndrome
* Patients being treated with glucocorticoid drugs or antibiotics.

Primary outcomes:
measure: Plasma inflammatory factors concentration
timeFrame: 8 weeks
Secondary outcomes:
measure: Plasma concentration of insulin
timeFrame: 8 weeks
measure: Plasma levels of lipids and lipoproteins
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Shahid Modares Hospital
Study officials:
References: