Anthocyanin Intake on Cardiometabolic Biomarkers

Last updated: May 3, 2025
Sponsor: Shahid Beheshti University
Overall Status: Completed

Phase

N/A

Condition

Coronary Artery Disease

Treatment

Dietary intervention

Anthocyanin-rich diet

Clinical Study ID

NCT05995002
43004233
  • Ages 30-75
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • coronary heart disease with recent coronary angiography

Exclusion

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

Total Participants: 62
Treatment Group(s): 2
Primary Treatment: Dietary intervention
Phase:
Study Start date:
August 21, 2023
Estimated Completion Date:
May 01, 2025

Study 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,

Connect with a study center

  • Shahid Modares Hospital

    Tehran,
    Iran, Islamic Republic of

    Site Not Available

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