Anthocyanin Intake on Cardiometabolic Biomarkers

Not Applicable

Completed

• Conditions: Coronary Artery Stenosis
• Interventions: Other: Anthocyanin-rich diet

• Registration Number: NCT05995002
• Lead Sponsor: Shahid Beheshti University

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,

Study Timeline

• Study First Submitted: 2023-08-08
• Study First Submitted QC: 2023-08-08
• Study First Posted: 2023-08-16
• Study Start: 2023-08-21
• Primary Completion: 2024-11-20
• Status Verified: 2024-12
• Study Completion: 2025-05-01
• Last Update Submitted: 2025-05-03
• Last Update Posted: 2025-05-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 62

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Anthocyanin-rich diet group	Anthocyanin-rich diet	Conventional drug treatment with a weekly food plan aims to increase the consumption of anthocyanin-rich sources

Primary Outcome Measures

Name	Time	Method
Plasma inflammatory factors concentration	8 weeks	fasting plasma concentration of C-reactive protein and IL-6

Secondary Outcome Measures

Name	Time	Method
Plasma concentration of insulin	8 weeks	Fasting plasma concentration of insulin
Plasma levels of lipids and lipoproteins	8 weeks	Fasting plasma levels of triglycerides, HDL-cholesterol, and LDL-cholesterol

Trial Locations

Locations (1)

Shahid Modares Hospital; 🇮🇷 Tehran, Iran, Islamic Republic of