The effects of Crocin supplementation on metabolic parameters, systemic inflammation and AMP- activated protein kinase, TNF-α and NF-Kβ in patients with type 2 diabetes.

The aim of this double-blind randomized clinical trial is to determine the effects of Crocin supplementation on metabolic parameters, systemic inflammation and AMP- activated protein kinase, Tumor Necrosis Factore-α and Nuclear Factor-Kappa β in patients with type 2 diabetes (T2DM).

This study is a double-blind, randomized controlled clinical trial with two parallel groups. 50 patients will be randomly assigned into Crocin and control group.

Patients with type 2 diabetes referring to the Diabetes Clinic of Imam-Hossein Hospital will be invited to participate. After assessing the entrance criteria, 10 cc blood samples are taken. The food recall and physical activity questionnaire is completed. Anthropometric measurements and blood pressure are taken. Supplements are given to patients for a month. For double-blind implementation(patients and investigators), all boxes of supplements by a third party is coded as A and B.

Inclusion criteria: Aged 30-70 years old; Body mass index 18.5-30; clinical diagnosis of T2DM (for at least one year); Non-inclusion criteria: having liver, kidney, inflammatory and pulmonary diseases; alcohol-drug abuse; pregnancy and lactation; insulin injection.

Intervention group :Crocin tablet; Control group: placebo tablet. Patients in the Crocin group will receive, for 12 weeks, two tablets of Crocina (Samisaz Company) per day, each containing 15 mg of Crocin. Patients in the control group will receive 2 tablets of placebo containing starch per day.

Serum concentrations of Glucose; Insulin; Insulin resistance index (HOMA-IR); Lipid profile; malondialdehyde; Total oxidant capacity; Total anti-oxidant capacity; High sensitivity c-reactive protein; Hemoglobin A1C levels; Interlukin-6; nuclear factor kappa-Β; Tumor necrosis factor-a; AMPK.

End of the intervention date

Patients on the basis of age and sex are categorized and are randomly assigned to the Crocin or placebo group. To random allocation, a Stratified Blocked Randomization method is used. After specifying blocks of size 4 and allocating numbers to each block, a random number table is used to determine the treatment assignment list. Randomization is concealed in sequentially numbered, sealed, opaque envelopes.

This study is a double-blind (investigators and patients) trial. For double-blind implementation, at the beginning of the study, all boxes containing crocin or placebo by a third party (someone other than the researchers) is coded as A and B.