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IRCT2016061128392N1 IRCT 2016-07-01 National Nutrition & Food Technology Research Institute (NNFTRI) Assessment of cinnamon effects in type 2 diabetic patients Assessment of cinnamon effects on advanced glycation end products, plasma vascular and systematic inflammation factors, antioxidant status, NF-kB and Sirtuin1 activity in mononuclear cells in type 2 diabetic patients 2016-03-19 anticipated 44 Complete https://irct.ir/trial/23048 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment. 1-2 DIABETES. Intervention 1: The intervention group: capsules 1 gr Cinnamon, 3 times per day, for 8 weeks. Intervention 2: Control group: capsules 1 gr microcristalin cellulose, 3 times per day, for 8 weeks.
public Behrouz Talaei
NO 7, St. shahid hafizi, West town, Tehran
Tehran Iran (Islamic Republic of) +98 21 2236 0656 B_TALAEI@HOTMAIL.COM Shahid Beheshti University of Medical Sciences Faculty of Nutrition Sciences and food technology scientific dr.Parvin Mirmiran
NO 7, St. shahid hafizi, West Town, Tehran
Tehran Iran (Islamic Republic of) +98 21 2236 0656 B_TALAEI@HOTMAIL.COM , parvin.mirmiran@gmail.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Inclusion criteria : Having type 2 diabetes for at least 10 years؛ FBS <180 and 2 h-blood-sugar <250 mg/dl؛ no pregnancy or lactation؛ no autoimmune disorder؛ without any thyroid , kidney , CVD diseases, thyroid and chronic inflammatory diseases, peptic ulcer and infection؛ no regular consumption of cinnamon or other herbal drugs؛ no sensitivity People who are just using the pills (not insulin)؛ your diabetes control cinnamon؛ body mass index (BMI) <30 kg/m ؛ Age between 70-25 years. Exclusion criteria : No observation of research protocol (no consumption of more than 20% of the capsules)؛ any sensitivity due to cinnamon consumption reported by the patient or noticed after the outset of the study؛ consumption of alcohol or narcotic drugs؛ and any variation in patients’ routine treatment according to physicians’ resolution (i.e., variation in type and dose of the drugs to be consumed, and treatment with insulin)؛ Pregnancy during the study. 70 years 25 years Both E11.9 Non-insulin-dependent diabetes mellitus without complications Treatment - Drugs Treatment - Drugs The intervention group: capsules 1 gr Cinnamon, 3 times per day, for 8 weeks. Control group: capsules 1 gr microcristalin cellulose, 3 times per day, for 8 weeks. Sirtuin Activity 1. Timepoint: Before and after the intervention. Method of measurement: ng/ml. Fasting insulin. Timepoint: Before and after the intervention. Method of measurement: mU/L. HOMA-IR. Timepoint: Before and after the intervention. Method of measurement: %. Fasting plasma glucose. Timepoint: Before and after the intervention. Method of measurement: mg/dl. Carboxymethyl-lysine plasma. Timepoint: Before and after the intervention. Method of measurement: ng/ml. Hb A1c. Timepoint: Before and after the intervention. Method of measurement: %. The activity NF-kB. Timepoint: Before and after the intervention. Method of measurement: ng/ml. VCAM-1. Timepoint: Before and after the intervention. Method of measurement: ng/ml. Hs-CRP. Timepoint: Before and after the intervention. Method of measurement: ng/ml. IL-6. Timepoint: Before and after the intervention. Method of measurement: ng/L. TNF. Timepoint: Before and after the intervention. Method of measurement: ng/L. ICAM-1. Timepoint: Before and after the intervention. Method of measurement: ng/ml. Vitamin E diet. Timepoint: Before and after the intervention. Method of measurement: mg/day. MUFA. Timepoint: Before and after the intervention. Method of measurement: gr/day. PUFA. Timepoint: Before and after the intervention. Method of measurement: gr/day. Salt diet. Timepoint: Before and after the intervention. Method of measurement: gr/day. SAFA. Timepoint: Before and after the intervention. Method of measurement: gr/day. Fat Diet. Timepoint: Before and after the intervention. Method of measurement: gr/day. Cholesterol diet. Timepoint: Before and after the intervention. Method of measurement: mg/day. Dietary fiber. Timepoint: Before and after the intervention. Method of measurement: mg/day. Protein Diet. Timepoint: Before and after the intervention. Method of measurement: gr/day. BMI. Timepoint: Before and after the intervention. Method of measurement: Kilograms per square meter. Carb Diet. Timepoint: Before and after the intervention. Method of measurement: gr/day. Total dietary energy. Timepoint: Before and after the intervention. Method of measurement: Kcal/day. Vitamin C diet. Timepoint: Before and after the intervention. Method of measurement: mg/day. Selenium diet. Timepoint: Before and after the intervention. Method of measurement: mcg/day. Research Institute for Endocrine Sciences, Shahid Beheshti University of Medical Sciences National Nutrition & Food Technology Research Institute (NNFTRI) Research Institute for Endocrine Sciences, Shahid Beheshti University of Medical Sciences Approved 2016-03-12 National Nutrition & Food Technology Research Institute (NNFTRI) NO 7, St. shahid hafizi, West town, Tehran Tehran Iran (Islamic Republic of)