Anthocyanin Intake on Cardiometabolic Biomarkers
Effects of Increasing Anthocyanin Intake on Cardiometabolic Biomarkers in Patients With Coronary Artery Disease
1 other identifier
interventional
62
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Aug 2023
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 8, 2023
CompletedFirst Posted
Study publicly available on registry
August 16, 2023
CompletedStudy Start
First participant enrolled
August 21, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 20, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2025
CompletedMay 6, 2025
December 1, 2024
1.3 years
August 8, 2023
May 3, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Plasma inflammatory factors concentration
fasting plasma concentration of C-reactive protein and IL-6
8 weeks
Secondary Outcomes (2)
Plasma concentration of insulin
8 weeks
Plasma levels of lipids and lipoproteins
8 weeks
Study Arms (2)
Control
NO INTERVENTIONConventional drug treatment with a general recommendation for a healthy diet.
Anthocyanin-rich diet group
EXPERIMENTALConventional drug treatment with a weekly food plan aims to increase the consumption of anthocyanin-rich sources
Interventions
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.
Eligibility Criteria
You may qualify if:
- coronary heart disease with recent coronary angiography
You may not qualify if:
- End-stage renal disease,
- Patients undergoing chemotherapy or radiotherapy,
- Patients with inflammatory bowel syndrome
- Patients being treated with glucocorticoid drugs or antibiotics.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Shahid Modares Hospital
Tehran, Tehran Province, Iran
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
August 8, 2023
First Posted
August 16, 2023
Study Start
August 21, 2023
Primary Completion
November 20, 2024
Study Completion
May 1, 2025
Last Updated
May 6, 2025
Record last verified: 2024-12
Data Sharing
- IPD Sharing
- Will not share