Anthocyanin Intake on Cardiometabolic Biomarkers

Status Recruiting

Clinical Trial 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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05995002
Study type	Interventional
Source	Shahid Beheshti University
Contact	Javad Nasrollahzadeh, PhD
Phone	+98212277424
Email	jnasrollahzadeh@gmail.com
Status	Recruiting
Phase	N/A
Start date	August 21, 2023
Completion date	June 27, 2024

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT05133843` - Complete Functional Assessment of Intermediate Coronary Artery Stenosis Before and After Transcatheter Aortic Valve Implantation (TAVI) in Patients With Severe Symptomatic Aortic Valve Stenosis	N/A
Completed	`NCT01205776` - EXCEL Clinical Trial	N/A
Completed	`NCT00739466` - Biorest Liposomal Alendronate With Stenting sTudy (BLAST)	Phase 2
Completed	`NCT01182428` - XIENCE V: SPIRIT WOMEN Sub-study	Phase 4
Completed	`NCT01332591` - Multivessel Disease Diagnosed at the Time of PPCI for STEMI: Complete Revascularization Versus Conservative Strategy.	N/A
Completed	`NCT00531011` - EXecutive RCT: Evaluating XIENCE V® in a Multi Vessel Disease	Phase 4
Completed	`NCT01310309` - EXecutive Registry: Evaluating XIENCE V® in a Multi Vessel Disease	Phase 4
Not yet recruiting	`NCT06052670` - Functional Diagnostic Accuracy of Ultrasonic Flow Ratio in Assessment of Coronary Artery Lesions
Completed	`NCT05509296` - Compare the Effectiveness and Safety of Two Different Kinds of Cutting Balloon in Coronary Artery Disease	N/A
Not yet recruiting	`NCT05393882` - Impact of Cholesterol Level on Long-term Coronary Bypass Graft Patency
Recruiting	`NCT06397820` - Relation Between AI-QCA and Cardiac PET
Active, not recruiting	`NCT01960504` - First in Man Study of the DREAMS 2nd Generation Drug Eluting Absorbable Metal Scaffold (BIOSOLVE-II)	N/A
Completed	`NCT01721096` - XIENCE PRIME Japan Post-Marketing Surveillance (PMS)
Active, not recruiting	`NCT01342822` - Trial to Assess the Everolimus-Eluting Coronary Stent System (PROMUS Element) for Coronary Revascularization	Phase 4
Completed	`NCT01205789` - EXCEL Clinical Trial (Universal Registry)	N/A
Recruiting	`NCT05532605` - Effects of Mindfulness Based Therapy on Illness and Depression in Cardiac Rehab Phase-i	N/A
Completed	`NCT02066623` - Observational Study to Evaluate Short and Long-term Safety of the ABSORB Scaffold
Not yet recruiting	`NCT02946320` - Optimal Predilatation Technique for BVS Implantation	Phase 3
Completed	`NCT01136876` - Kidney Damage in Patients With Moderate Fall in eGFR	Phase 4
Terminated	`NCT01136915` - Kidney Damage In Patients With Severe Fall In eGFR	Phase 4

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.