The study of the effect of nano-curcumin supplementation on endothelial function, serum endocan and homocysteine levels in overweight or obese patients with coronary slow flow phenomenon
To investigate the effect of nano-curcumin supplementation on adropin, endocan and homocysteine levels and different aspects of angina pectoris in overweight or obese patients with coronary slow flow phenomenon
Design
Randomized, double-blind, placebo-controlled, parallel trial with two arms (each arm includes 21 patients and overall sample size is 42) and stratified permuted block randomization is used.
Settings and conduct
Patient selection from Rajaie Heart Hospital, Tehran
Taking one capsule per day for 12 weeks
Blood sample collection, bio-electrical impedance analysis of body composition, and filling out questionnaires before and after the intervention
Blinding patients and investigators by using identical boxes with either code A or B for nano-curcumin or placebo without knowing the content of each box
Participants/Inclusion and exclusion criteria
Inclusion criteria:
40 to 65 years old men and women with body mass index between 25 to 34.9,
angiographically diagnosed as coronary slow flow phenomenon, with coronary stenosis less than 40% and left ventricular ejection fraction higher than 55%, by giving informed consent
Exclusion criteria:
Premature menopause, smoking, addiction and alcohol consumption, regular exerciser, routine use of anticonvulsants, corticosteroids, immunosuppressants, antiinflammatory and aphrodisiac medication or antioxidants, omega3, vitamin B12, folic acid or vitamin B6 supplements, uncontrolled hypertension, past medical history of thyroid, renal, hepatic, hematologic, autoimmune, systemic, connective tissue, pulmonary and heart diseases, malignancy
Intervention groups
1.The group taking nano-curcumin 80 mg soft gel capsules
2. The group taking placebo soft gel capsules
(Both provided by Exir Nano Sina Co.)
Main outcome variables
Serum levels of adropin, endocan and homocysteine
Different aspects of angina evaluated by Seattle Angina Questionnaire
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20131125015536N8
Registration date:2019-06-19, 1398/03/29
Registration timing:prospective
Last update:2019-06-19, 1398/03/29
Update count:1
Registration date
2019-06-19, 1398/03/29
Registrant information
Name
Mohammad Javad Hosseinzadeh
Name of organization / entity
School of Nutritional Sciences and Dietetics, TUMS
Country
Iran (Islamic Republic of)
Phone
+98 21 8899 3059
Email address
mhosseinzadeh@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-07-22, 1398/04/31
Expected recruitment end date
2020-04-02, 1399/01/14
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The study of the effect of nano-curcumin supplementation on endothelial function, serum endocan and homocysteine levels in overweight or obese patients with coronary slow flow phenomenon
Public title
Effect of Nano-curcumin in Coronary Slow Flow Phenomenon
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
40 to 65 years old men and women
BMI range: 25 - 34.9
Angiographically diagnosed as coronary slow flow phenomenon by Corrected TIMI Frame Count (CTFC) method which is equivalent to 27 or higher for one or more coronary vessels.
Normal coronary vessels with coronary stenosis less than 40%
Left ventricular ejection fraction higher than 55%
Giving informed consent for participation in the study
Exclusion criteria:
Premature menopause
Smoking, addiction, alcohol consumption
Routine use of NSAIDs or antioxidants one month prior to study
Use of aphrodisiac medication within 9 months before study
Routine use of corticosteroids or immunosuppressants
Use of anticonvulsants
Taking antioxidant or omega3 supplements (more than 3 grams per day) at least twice a week within 3 months prior to study
Taking vitamin B12, folic acid or vitamin B6 supplements within one month before study
Being a professional athlete or excising regularly
Uncontrolled hypertension defined as diastolic blood pressure above 90 mmHg, systolic blood pressure above 140 mmHg.
Past medical history: hypothyroidism or hyperthyroidism
Malignancy
Chronic obstructive pulmonary diseases
Systemic diseases
Connective tissue diseases
Renal failure
Liver failure
Autoimmune diseases
Myocardial Infarction
Sever heart failure
Heart transplant
Revascularization procedure or PCI or CABG
Left ventricular dysfunction or echocardiographically diagnosed left ventricular hypertrophy
Cardiac conduction disturbances
Valvular heart disease
Atrial fibrillation
Aneurysms
Cardiomyopathy
Congenital heart disease
Coronary artery disease
Hematologic disorders
Age
From 40 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Investigator
Outcome assessor
Sample size
Target sample size:
42
Randomization (investigator's opinion)
Randomized
Randomization description
Study participants will be assigned to nano-curcumin or placebo groups by stratified permuted block randomization. As the first step, we will have stratified randomization for gender. Then, either points 1 or 0 will be given to various confounding factors in this study. For example, having family history of coronary artery disease: 1 and no family history of CAD: 0,
diabetes mellitus:1 , no diabetes mellitus: 0
hypertention: 1, no hypertention: 0
dyslipidemia: 1 , no dyslipidemia: 0
Using any of these medications: ACE-I, ARBs, beta-blockers, statins, anticoagulants, calcium channel blockers and nitrates: 0, no use: 1.
The sum of these points will be a score between 0 to 5 for each patient. The patients with scores less than 3 will be considered as low risk and patients with scores equivalent to or higher than 3 will be considered as high risk for endothelial dysfunction and then, they will go through stratified randomization according to their risk of endothelial dysfunction.
Patients are randomized by using permuted blocks of size 4 and 6 (specific random number tables will be used).
Blinding (investigator's opinion)
Double blinded
Blinding description
Using identical boxes with either A or B code labels for nano-curcumin and placebo supplements, will help to blind both patients and investigators.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Tehran University of Medical Sciences
Street address
Sixth Floor, Central Organization of Tehran University of Medical Sciences, Qods St, Keshavarz Blvd,Tehran
City
Tehran
Province
Tehran
Postal code
1417653761
Approval date
2019-05-06, 1398/02/16
Ethics committee reference number
IR.TUMS.VCR.REC.1398.109
Health conditions studied
1
Description of health condition studied
Coronary Slow Flow Phenomenon (CSFP)
ICD-10 code
I20.8
ICD-10 code description
Other forms of angina pectoris
Primary outcomes
1
Description
Serum Homocysteine levels
Timepoint
Before and after 12 weeks of intervention
Method of measurement
Enzymatic Kit
2
Description
Serum Adropin levels
Timepoint
Before and after 12 weeks of intervention
Method of measurement
Eliza kit
3
Description
Serum Endocan levels
Timepoint
Before and after 12 weeks of intervention
Method of measurement
Eliza kit
4
Description
Different aspects of angina pectoris
Timepoint
Before and after 12 weeks of intervention
Method of measurement
Seattle Angina Questionnore
Secondary outcomes
1
Description
Body composition analysis
Timepoint
Before and after 12 weeks of intervention
Method of measurement
Bio-electrical impedance analysis
2
Description
Serum lipid profile
Timepoint
Before and after 12 weeks of intervention
Method of measurement
Enzymatic Kit
3
Description
Serum alkaline phosphatase levels
Timepoint
Before and after 12 weeks of intervention
Method of measurement
Enzymatic Kit
Intervention groups
1
Description
Intervention group: Dietary supplement nano-curcumin 80 mg one capsule daily (Exir Nano Sina Co.)
Category
Treatment - Other
2
Description
Control group: Placebo supplement one capsule daily (Exir Nano Sina Co.)
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Rajaei cardiovascular, medical and research center
Full name of responsible person
Ata Firouzi
Street address
Valiasr Ave, Niayesh Intersection, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1995614331
Phone
+98 21 23921
Fax
+98 21 2204 2026
Email
atafirouzi@yahoo.com
Web page address
http://rhc.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Mohammad Ali Sahraian
Street address
Sixth floor, Central Organization of Tehran University of Medical Sciences, Ghods St, Keshavarz Blvd, Tehran
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 8163 3685
Email
msahrai@sina.tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?