The effect of curcumin supplementation on non invasive arterial stiffness indices in metabolic syndrome patients

Determination of the effect of curcumin supplementation on non invasive arterial stiffness indices in metabolic syndrome patients

Clinical trial with control group, parallel groups, double blind, randomized

The site of this study is Imam Reza Hospital in Mashhad. Eighty patients with metabolic syndrome will be studied. Individuals are randomly divided into two groups of curcumin and placebo. At the beginning and the end of the study, anthropometric and arterial stiffness indices are measured.The level of physical activity is obtained using a questionnaire. The 48-hour food recall and the food frequency questionnaire are completed. Also a blood sample is taken to measure lipid profile, liver enzymes and fasting blood suger. In this study, participants, original researcher and sphygmocor machine operator are blind.

Inclusion criteria • willingness to participate in the study and the completion of informed consent form • metabolic syndrome Patients exclusion criteria • Curcumin sensitivity • Regular use of anti-diabetes drugs, antiplatelet drugs, statins, antioxidant supplements, anti-inflammatory drugs, analgesics • Use of multivitamin or herbal supplements • Liver disease, autoimmune disease, biliary disease, obstructive disease, diabetes, kidney failure, malignancy, Gallstone, calcium oxalate stones • Pregnancy and breastfeeding • Drug abuse • Smoking hookah or cigarettes

Intervention group: A single dose of curcumin (500 mg) for 12 weeks. Control group: A single dose of placebo for 12 weeks

Augmentation Index, Augmentation Index75, pulse wave velocity, Augmentation pressure

In this study, stratified randomization will be used. First, the participants will be stratified based on age and sex (male or female) and then they will be allocated to intervention or placebo group based on the blocks of size 4. Blocks of size 4 have 10 modes(AABB, ABAB, BBAA, BABA, AAAB, BBBA, AAAA, BBBB, ABBB, BAAA).

In this study, the original researcher who is responsible for randomization, Giving supplements and drafting the article is blind. Also, participants are aware of their participation in the research project but they do not know which study group they are in. The sphygmocor apparatus operator, which is responsible for evaluating arterial stiffness indices, is also blind in this study.

There is no further information.