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NCT Number: NCT05995002

Anthocyanin Intake on Cardiometabolic Biomarkers

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.

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Key information

Age range

30 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shahid Modares Hospital

Tehran, Tehran Province, Iran

About this study

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,

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Anthocyanin-rich diet

Other

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.

Primary outcomes

  1. Plasma inflammatory factors concentration

    Time frame: 8 weeks

    fasting plasma concentration of C-reactive protein and IL-6

Secondary outcomes

  1. Plasma concentration of insulin

    Time frame: 8 weeks

    Fasting plasma concentration of insulin

  2. Plasma levels of lipids and lipoproteins

    Time frame: 8 weeks

    Fasting plasma levels of triglycerides, HDL-cholesterol, and LDL-cholesterol

Sponsors and collaborators

Lead sponsor

Shahid Beheshti University

Other

Collaborators

  • Shahid Beheshti University of Medical Sciences

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
Aug 16, 2023
Registry last updated
May 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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