Effect of Rosemary (Rosmarinus officinalis) leaves powder on glycemic indexes, lipid profile, total antioxidant capacity, SOD, GSH-Px and hs-CRP in patients with type 2 diabetes

Effect of Rosemary (Rosmarinus officinalis) leaves powder on Glycemic indexes, Lipid profile, Total Antioxidant capacity, SOD, GSH-Px and hs-CRP in Patients with Type 2 Diabetes

A double-blind randomized clinical trial with 90 patients with Type 2 diabetes. Randomization with Using random blocks.

In this study, 90 Patients with Type 2 Diabetes referred to the Endocrinology Clinic of Imam Khomeini Hospital will be divided into two intervention or control groups and will be followed for 12 weeks. All Laboratory tests, anthropometric indices and blood pressure will be measured at the beginning of the study and at the end of the twelfth week. To make the study double-blind, unique codes will be used on the sachets in the randomization process, and the placebo sachets will have the same interior and exterior appearance as the rosemary sachets, and none of the participants and researchers from the group where they will be placed and the type of intervention (rosemary powder or placebo) will not know.

Inclusion criteria: satisfaction; diagnosis of Type 2 Diabetes; at least one year of history of Diabetes; age range 25 to 70 years old; do not take any antioxidant and dietary supplements during last 2 months; no pregnancy and lactation; no other chronic and inflammatory diseases. Exclusion criteria: alcohol consumption; smoking any drugs; Insulin use; any allergies.

1: Intervention (n=45): daily consumption of 4 grams of rosemary leaf powder with diet recommendation 2: (n=45): receive 4 grams of starch with diet recommendation

Fasting blood sugar; fasting insulin; insulin resistance; quantitative insulin sensitivity check index; total serum cholesterol and triglyceride; HDL-C, LDL-C; total antioxidant capacity; SOD; GSH-PX; high sensitivity C-reactive protein

For randomized allocation performing, permuted block randomization will be used by blocks. According to the sample size of 90 subjects, 15 blocks will be generated using the online site (www.sealedenvelope.com). In order to allocation concealment in the randomized process, unique codes will be used on the drug sachets that is generated by the software. Participants will enter based on the sequence produced into study and the drug sachets with code registered will allocate to the individual. Therefore, before participants selection, they will be unaware of the type of intervention that will receive, as well as the researcher, and random sequence produced during the study will be immune from prediction.

In order to perform a double-blind study in order to apply concealment in the randomization process, unique codes will be used on the sachets that code will generate by the software. As each individual enters the study, based on the sequence generated, the powder containing the code in which the code is intended will be assigned to the individual, and the rosemary or placebo powder will be coded by a third party who is unaware of the contents of the sachets. Its is randomly divided into two groups by the above method. None of the participants, as well as the researcher, will be aware of the group (rosemary or placebo) that will be included and the type of intervention (rosemary or placebo powder) and the powder containing cartridges as well as the placebo and rosemary cartridges. They will be similar in appearance and exterior.

Only a section of the data, such as primary outcomes information or the like, will be shared.

Access period start 6 months after results publishing.

The obtained data from current study will be available only for working researchers in academic and scientific institutions.

Six months after the publicated papers from this study, the obtained data will be available to the researchers for further analysis.

Applicants can be communicated to correspond author be e-mail or postal address to receive the requested data. Postal address: Nutrition Department, School of Public Health, Iran University of Medical Sciences, Hemat Highway, Tehran Cell phone: +982186704743 Email: n-aryaeian@sina.tums.ac.ir

Publishing in scientific-research journals Applicants will be given access to the obtained data from current study by sending an email to correspond author.