Anthocyanin Intake on Cardiometabolic Biomarkers

Effects of Increasing Anthocyanin Intake on Cardiometabolic Biomarkers in Patients With Coronary Artery Disease

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.

Study Overview

• Status: Recruiting
• Conditions: Coronary Artery Stenosis
• Intervention / Treatment: Other: Anthocyanin-rich diet

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 Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Javad Nasrollahzadeh, PhD; Phone Number: +98212277424; Email: jnasrollahzadeh@gmail.com

Study Locations

• Iran, Islamic Republic of
  • Tehran, Iran, Islamic Republic of
    • Recruiting
    • Shahid Modares Hospital
    • Contact: Sogand Tavakoli; Phone Number: +98 9121792248

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; Conventional drug treatment with a general recommendation for a healthy diet.
Experimental: Anthocyanin-rich diet group; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Plasma inflammatory factors concentration	fasting plasma concentration of C-reactive protein and IL-6	8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Plasma concentration of insulin	Fasting plasma concentration of insulin	8 weeks
Plasma levels of lipids and lipoproteins	Fasting plasma levels of triglycerides, HDL-cholesterol, and LDL-cholesterol	8 weeks

Collaborators and Investigators

• Sponsor: Shahid Beheshti University
• Collaborators: Shahid Beheshti University of Medical Sciences

Study record dates

Study Major Dates

• Study Start (Actual): August 21, 2023
• Primary Completion (Estimated): May 19, 2024
• Study Completion (Estimated): June 27, 2024

Study Registration Dates

• First Submitted: August 8, 2023
• First Submitted That Met QC Criteria: August 8, 2023
• First Posted (Actual): August 16, 2023

Study Record Updates

• Last Update Posted (Actual): March 12, 2024
• Last Update Submitted That Met QC Criteria: March 9, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Coronary Disease; Coronary Stenosis
• Other Study ID Numbers: 43004233

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No