Anthocyanin Intake on Cardiometabolic Biomarkers
Primary Purpose
Coronary Artery Stenosis
Status
Recruiting
Phase
Not Applicable
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Anthocyanin-rich diet
Sponsored by
About this trial
This is an interventional prevention trial for Coronary Artery Stenosis
Eligibility Criteria
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.
Sites / Locations
- Shahid Modares HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Control
Anthocyanin-rich diet group
Arm Description
Conventional drug treatment with a general recommendation for a healthy diet.
Conventional drug treatment with a weekly food plan aims to increase the consumption of anthocyanin-rich sources
Outcomes
Primary Outcome Measures
Plasma inflammatory factors concentration
fasting plasma concentration of C-reactive protein and IL-6
Secondary Outcome Measures
Plasma concentration of insulin
Fasting plasma concentration of insulin
Plasma levels of lipids and lipoproteins
Fasting plasma levels of triglycerides, HDL-cholesterol, and LDL-cholesterol
Full Information
NCT ID
NCT05995002
First Posted
August 8, 2023
Last Updated
September 3, 2023
Sponsor
Shahid Beheshti University
Collaborators
Shahid Beheshti University of Medical Sciences
1. Study Identification
Unique Protocol Identification Number
NCT05995002
Brief Title
Anthocyanin Intake on Cardiometabolic Biomarkers
Official Title
Effects of Increasing Anthocyanin Intake on Cardiometabolic Biomarkers in Patients With Coronary Artery Disease
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 21, 2023 (Actual)
Primary Completion Date
February 19, 2024 (Anticipated)
Study Completion Date
April 27, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shahid Beheshti University
Collaborators
Shahid Beheshti University of Medical Sciences
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
Detailed 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,
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Stenosis
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
No Intervention
Arm Description
Conventional drug treatment with a general recommendation for a healthy diet.
Arm Title
Anthocyanin-rich diet group
Arm Type
Experimental
Arm Description
Conventional drug treatment with a weekly food plan aims to increase the consumption of anthocyanin-rich sources
Intervention Type
Other
Intervention Name(s)
Anthocyanin-rich diet
Intervention Description
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 Outcome Measure Information:
Title
Plasma inflammatory factors concentration
Description
fasting plasma concentration of C-reactive protein and IL-6
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Plasma concentration of insulin
Description
Fasting plasma concentration of insulin
Time Frame
8 weeks
Title
Plasma levels of lipids and lipoproteins
Description
Fasting plasma levels of triglycerides, HDL-cholesterol, and LDL-cholesterol
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Javad Nasrollahzadeh, PhD
Phone
+98212277424
Email
jnasrollahzadeh@gmail.com
Facility Information:
Facility Name
Shahid Modares Hospital
City
Tehran
Country
Iran, Islamic Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sogand Tavakoli
Phone
+98 9121792248
12. IPD Sharing Statement
Plan to Share IPD
No
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Anthocyanin Intake on Cardiometabolic Biomarkers
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