Evaluation the simultaneus effect of Probiotic (Lactobacillus Acidufilus) and Cinnamomum on glycemic index, lipid profile, antioxidant and inflammatory parameters in diabetic type 2 patients.

Determining the effect of consumption symbiotic supplement (Lactobacillus Acidophilus and Cinnamon) on lipid profile (LDL,HDL,CHOL,TG), inflammatory (TNFα, CRP), anti inflammatory( IL10), antioxidant factors and glycemic index in diabetic type 2 patients.

In this research, 120 eligible diabetic type2 patients were chosen purposefully and a code was allocated to each one of them. Then, patients were randomly divided into one control and three intervention groups. This study is a double blind randomized clinical test. The randomization method is block randomization and random numbers table. Clinical trial phase:2-3

Setting: Preparing probiotic bacteria: at first, in laboratory, lactobacillus acidophilus bacteria is cultured and after freez drying filled in the cap to 108 cfu (cap A). 0.5 grams Cinnamon powder is filled in the cap (cap B). 0.5 grams Rice flour is filled in another cap (cap C) as the placebo. Place of randomization is the clinic.The study is double blind. The person who put drugs in the cans and tags on them, person who select eligible patients, person who block and specify drug and placebo and the physician and the patients don’t know about contents.

Inclusion criteria: Age between 25 to 65 years; Fasting blood sugar between 126 to 250 mg/dL; HbA1c less than 7.5; exclusion criteria: People who are younger than 25 years old and older than 65 years old; People with severe diabetes (The blood sugar more than 250); Women in pregnancy and lactation periods; People who consume special drugs (drugs which affect on blood sugar, such as corticosteroids, diuretics); Usage insulin, vitamin supplements and herbal; Chang e in diabetes medicine during last 6 months; People who don't tolerate lactose; Patients who have artificial heart valve; Patients with short bowel syndrome; Patients with chronic live , renal, lung, diseases and uncontrollable blood pressure; Patients with allergy; Patients with special diet or physical activity.

group 1:This group receive a cap includes lactobacillus acidophilus bacteria 108 cfu and a cap includes 0.5 grams cinnamon powder, daily in 90 days period.(cap A and cap B) *group 2:This group receive a cap includes lactobacillus acidophilus bacteria 108 cfu and , daily in 90 days period.(cap A) *group 3:This group receive a cap includes 0.5 grams cinnamon powder, daily in 90 days period.(cap B) *group 4:This group receive a cap includes 0.5 grams rice flour powder, daily in 90 days period (cap C)

Lipid profile(total cholestrol,LDL, HDL,TG); Fasting blood sugar; HbA1C; IL10; TNFα; CRP; Superoxide dismutase enzyme; Glutathione proxidase

Vice chancellor for research, Alborz University Of Medical Science

For randomization we use, block randomization and random numbers table. In this rule, eligible patients have been divided to blocks with4 or 6 members. We will get to half patients the numbers that first right digit of it, is even and to the others numbers that first right digit of it is odd, in the random numbers table.Then we will get to the half of patients (who have even numbers) herbal drug and to the others (who have odd numbers) placebo. Place of randomization is the clinic. Herbal drug and placebo is packed in the same package, except performer of Project, none has not information about it. Total of sample is 120 and patients will use drug packages randomly.

Randomization is double blind.The person who put drugs in the cans and tags on them, person who select eligible patients, person who block and specify drug and placebo and the physician and the patients don’t know about contents.