Unique ID issued by UMIN | UMIN000018339 |
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Receipt number | R000021227 |
Scientific Title | Investigation of the effects of supplementation with curcuminoids in subjects with metabolic syndrome |
Date of disclosure of the study information | 2015/07/17 |
Last modified on | 2015/07/17 22:54:52 |
Investigation of the effects of supplementation with curcuminoids in subjects with metabolic syndrome
Curcuminoid supplementation in metabolic syndrome
Investigation of the effects of supplementation with curcuminoids in subjects with metabolic syndrome
Curcuminoid supplementation in metabolic syndrome
Asia(except Japan) |
Metabolic syndrome
Cardiology | Endocrinology and Metabolism |
Others
NO
Evaluation of curcuminoids' effects on serum lipid concentrations
Efficacy
Confirmatory
Pragmatic
Phase II
Changes in serum levels of total cholesterol, LDL- cholesterol, HDL-cholesterol, triglycerides, lipoprotein(a), small-dense LDL and non-HDL-cholesterol
Changes in serum levels of adiponectin, leptin, C-reactive protein, malondialdehyde, superoxide dismutase, tumor necrosis factor-alpha, transforming growth factor-beta, interleukin-6 and monocyte chemoattractant protein-1
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Placebo
NO
NO
Institution is not considered as adjustment factor.
NO
Pseudo-randomization
2
Treatment
Medicine |
Curcuminoids (1000 mg/day)
Placebo
25 | years-old | <= |
75 | years-old | > |
Male and Female
Diagnosis of metabolic syndrome based on the National Cholesterol Education Program Adult Treatment Panel III (NCEP-ATP III) guidelines a follows: >= 3 of the following conditions: waist circumference >= 102 cm (male) or >= 88 cm (female), blood pressure >= 130/85 mmHg, triglycerides >= 1.7 mmol/L, HDL-C < 1.03 mmol/L (males) or < 1.29 mmol/L (females), fasting plasma glucose (FPG) >= 6.1 mmol/L.
Pregnancy and breastfeeding, non-compliance with the study medication (defined as not using the medication for > 1 week), participation in a concomitant trial, hypersensitivity to the study medication, presence of malignancies and Impossibility to give informed consent.
100
1st name | |
Middle name | |
Last name | Amirhossein Sahebkar |
Mashhad University of Medical Sciences, Mashhad, Iran
Biotechnology Research Center
Vakilabad blvd. Mashhad 9177948564, Iran
+989151221496
amir_saheb2000@yahoo.com
1st name | |
Middle name | |
Last name | Amirhossein Sahebkar |
Mashhad University of Medical Sciences, Mashhad, Iran
Biotechnology Research Center
Vakilabad blvd. Mashhad 9177948564, Iran
+989151221496
amir_saheb2000@yahoo.com
Clinical Trial Research Center, Baqiyatallah University of Medical Sciences, Tehran, Iran
Clinical Trial Research Center, Baqiyatallah University of Medical Sciences, Tehran, Iran
Outside Japan
Clinical Trial Research Center, Baqiyatallah University of Medical Sciences, Tehran, Iran
Mashhad University of Medical Sciences, Mashhad, Iran
Mashhad University of Medical Sciences, Mashhad, Iran
NO
Endocrinology Clinic, Baqiyatallah Hospital, Tehran, Iran
Cardiology Clinic, Baqiyatallah Hospital, Tehran, Iran
2015 | Year | 07 | Month | 17 | Day |
Partially published
Significant reductions in palsma concentrations of total cholesterol, LDL-cholesterol, triglycerides,non-HDL-choletserol and lipoprotein(a), and elevations in HDL-cholesterol following 8-week supplementation with curcuminoids.
Completed
2013 | Year | 01 | Month | 15 | Day |
2013 | Year | 05 | Month | 01 | Day |
2015 | Year | 07 | Month | 17 | Day |
2015 | Year | 07 | Month | 17 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021227
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