The study of the effect of nano-curcumin supplementation on biomarkers of endothelial function and inflammation in overweight or obese patients with Coronary Slow Flow Phenomenon

To investigate the effect of nano-curcumin supplementation on biomarkers of endothelial function and inflammation in overweight or obese patients with Coronary Slow Flow Phenomenon

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.

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

Inclusion criteria: 35 to 70 years old men and women with body mass index between 25 to 39.9, angiographically diagnosed as coronary slow flow phenomenon, with coronary stenosis less than 40% and left ventricular ejection fraction higher than 45%, by giving informed consent Exclusion criteria: Premature menopause, 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

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.)

Serum levels of adropin,endocan,homocysteine,visfatin,hs-CRP,uric acid,Different aspects of angina and quality of life evaluated by Seattle Angina and SF-36 Questionnaire

As Coronary Slow Flow Phenomenon is an uncommon disease and on the other hand we had limited inclusion criteria , we had to widen some of inclusion criteria. For example, we extended age range to 35-70 years old , body mass index to 25-39.9 and ejection fraction ≥45%. More over we omitted smoking as an exclusion criterium. Stratified Permuted Block Randomization is used for randomization. Being smoker was added to confounding factors and smokers got point 1 and non-smokers got point 0 . Considering the previous confounding factors , sum of all points will be a score between 0-6. The patients with scores 3 and below will be considered as low risk and patients with scores equivalent to or higher than 4 will be considered as high risk for condition of the disease and then, they will go through stratified randomization according to their risk level. Since in a concurrent approved project we studied the effects of nano curcumin on some inflammatory factors on this population , the purpose of this study is changed to “the study of the effect of nano-curcumin supplementation on biomarkers of endothelial function and inflammation in overweight or obese patients with Coronary Slow Flow Phenomenon”. For this reason , serum visfatin , hs-CRP , uric acid and 36-items short form quality of life questionnaire were added as primary outcomes. Also Blood Urea Nitrogen , creatinine , Fasting Blood Sugar , insulin , Hemoglobin A1C and CBC were measured to secondary outcomes.

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 smoker:1 , non-smoker: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 6 for each patient. The patients with scores 3 and below will be considered as low risk and patients with scores equivalent to or higher than 4 will be considered as high risk for condition of the disease and then, they will go through stratified randomization according to their risk level. Patients are randomized by using permuted blocks of size 4 and 6 (specific random number tables will be used).

Using identical boxes with either A or B code labels for nano-curcumin and placebo supplements, will help to blind both patients and investigators.

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