Anthocyanin Intake on Cardiometabolic Biomarkers

Shahid Beheshti University

Status: Completed

Conditions: Coronary Artery Stenosis

Treatments: Other: Anthocyanin-rich diet

Study type: Interventional

Funder types: Other

Identifiers

NCT05995002

43004233

Details and patient eligibility

About

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.

Full 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,

Enrollment: 62 patients

Sex: All

Ages: 30 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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62 participants in 2 patient groups

Control

No Intervention group

Description:

Conventional drug treatment with a general recommendation for a healthy diet.

Anthocyanin-rich diet group

Experimental group

Description:

Conventional drug treatment with a weekly food plan aims to increase the consumption of anthocyanin-rich sources

Treatment:

Other: Anthocyanin-rich diet