Investigation of the effect of pistachio plant fixed oil (Pistacia atlantica subsp. Kurdica) (as softgel) on control of blood sugar, lipid profile, inflammatory factors and oxidative stress in people with type 2 diabetes: Double-blind randomized clinical trial

Determining the effect of essential oil of pistachio (Pistacia atlantica subsp. Kurdica) on the control of blood sugar, lipid profile, inflammatory factors, and oxidative stress in patients with type 2 diabetes and its comparison with the control group

Two arms parallel-group randomized trial with control group, double-blind, phase 2 on 70 patients, randomization software (RAS) was used for randomization.

70 people with type 2 diabetes referred to the Diabetes Clinic of Taleghani Hospital are selected by physicians according to the criteria of the American Diabetes Association. Individuals will be randomly divided into two groups: placebo and intervention. Researchers and participants were blinded by the study group. The codes assigned to each participant are grouped by an unaware person to the study.

Inclusion criteria: Being over 18 years old, Having 2 years of history of type 2 diabetes according to the American Diabetes Association criteria, Body mass index (BMI) greater than or equal to 25 kg/m2; Exclusion criteria: Pregnancy, Lactation, Insulin injection, People with autoimmune diseases, People with gastrointestinal diseases, People with liver disease, People with kidney disease, People with cardiovascular disease, People with a severe respiratory illness, Consumption of any vitamins, minerals, and dietary supplements, Alcohol consumption, Consumption of plant sterols, Consumption of psyllium, Consumption of fish oil, Existence of allergies to pistachio plant species

Intervention group: 1500 mg of pistachio oil three times per day with each meal. Placebo group: 1500 mg of soft gel placebo daily with the same shape, color, and size. The duration of the intervention will be 12 weeks.

Fasting blood sugar, LDL cholesterol, High-sensitivity C-reactive Protein

In this study, the randomization method is simplified and it is individual randomization so that, after meeting the inclusion criteria, each person is assigned a random code created by random allocation software (RAS). After that, these codes are randomly divided into two groups as intervention and control groups by a third person who is unaware of the study and its conditions.

Participants in this study do not know whether they are in the intervention or control group, Researchers do not know which participant is in the intervention or control group. In order to blindness, each participant in the study is assigned a random code created by random allocation software (RAS), and these codes are divided into two groups by a third person who is unaware of the study and its conditions.

All data related to the primary and secondary outcome will be shared

Access starts 6 months after the results are published

Researchers in academic and scientific institutions, as well as people in the industry, are allowed to access the data

Anyone who request our data should provide a brief explanation of the purpose and method of their meta-analysis study. The applicant's request will be reviewed by the researchers and if all agree, the requested data will be sent to the applicant via email in the form of an Excel file. All of these steps will not take more than 10 days.

Amir Saber, Assistant Professor, Kermanshah University of Medical Sciences, Faculty of Nutrition Sciences and Food Industry, Address: Faculty of Nutrition Sciences and Food Industry, Next to Farabi hospital, Esar Square, Kermanshah Postal code: 6719851552 Phone: 0098 83 37102009 Email: amir.saber@kums.ac.ir

After sending the request by the applicant and confirming the goals and method of the study by all project researchers, the data will be provided by email in less than 10 days.