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IRCT20200912048693N2 IRCT 2021-02-25 Kermanshah University of Medical Sciences Evaluation of the effect of pistachio oil on people with type 2 diabetes 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 2021-05-20 anticipated 70 Complete https://irct.ir/trial/54501 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: 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, Blinding description: 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. 2-3 Type 2 diabetes mellitus. Intervention 1: Intervention group: Consumption material: Ripe pistachio fruit oil; Chemical composition and concentration: α-Pinene (30.1%), Oxygenated monoterpenes (21.2 %), Sesquiterpene hydrocarbons (9.6 %), Bornyl acetate (8.5 %), Camphene (5.7 %), Myrcene (5.4 %), Spathulenol (5.3 %), α-Terpineol (4.1 %), Limonene (3.8 %), Germacrene D (2.7 %), α-Terpinolene (2.1 %) and other constituents (1.5 %); Dosage: 1500 mg per day; Daily usage: 3 times a day; Duration of use: 12 weeks; How to use: orally 500 mg soft gel; 500 mg soft gels are produced by Zahravi Pharmaceutical Company after oil extraction from ripe pistachio fruit by cold press method. Intervention 2: Control group: Consumption material: soybean oil; Chemical composition and concentration: palmitic acid (10%), stearic acid (4%), oleic acid (18%), linoleic acid (55%), and linolenic acid (13%); Dosage: 1500 mg per day; Daily usage: 3 times a day; Duration of use: 12 weeks; How to use: orally 500 mg soft gel; After purchasing soybean oil, 500 mg soft gels are produced by Zahravi Pharmaceutical Company. Yes - There is a plan to make this available What will be shared: All data related to the primary and secondary outcome will be shared When: Access starts 6 months after the results are published To whom: Researchers in academic and scientific institutions, as well as people in the industry, are allowed to access the data Conditions: 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. Where to obtain: 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 How to obtain: 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. Comments:
public Amir Saber
Faculty of Nutrition Sciences and Food Industry, Next to Farabi hospital, Esar Square, Kermanshah
Kermanshah Iran (Islamic Republic of) 6719851552 +98 83 3710 2009 amir.saber@kums.ac.ir Kermanshah University of Medical Sciences scientific Amir Saber
Faculty of Nutrition Sciences and Food Industry, Next to Farabi hospital, Esar Square, Kermanshah
Kermanshah Iran (Islamic Republic of) 6719851552 +98 83 3710 2009 amir.saber@kums.ac.ir Kermanshah University of Medical Sciences Iran (Islamic Republic of) Having a 2-year history of type 2 diabetes according to the American Diabetes Association criteria Body mass index (BMI) greater than or equal to 25 kg/m2 18 years no limit Both Pregnancy Lactation Insulin injection People with autoimmune diseases People with gastrointestinal diseases People with liver disease People with kidney disease People with thyroid disease People with cardiovascular disease People with severe respiratory illness such as asthma and chronic bronchitis 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 E11 Type 2 diabetes mellitus Rehabilitation Placebo Intervention group: Consumption material: Ripe pistachio fruit oil; Chemical composition and concentration: α-Pinene (30.1%), Oxygenated monoterpenes (21.2 %), Sesquiterpene hydrocarbons (9.6 %), Bornyl acetate (8.5 %), Camphene (5.7 %), Myrcene (5.4 %), Spathulenol (5.3 %), α-Terpineol (4.1 %), Limonene (3.8 %), Germacrene D (2.7 %), α-Terpinolene (2.1 %) and other constituents (1.5 %); Dosage: 1500 mg per day; Daily usage: 3 times a day; Duration of use: 12 weeks; How to use: orally 500 mg soft gel; 500 mg soft gels are produced by Zahravi Pharmaceutical Company after oil extraction from ripe pistachio fruit by cold press method. Control group: Consumption material: soybean oil; Chemical composition and concentration: palmitic acid (10%), stearic acid (4%), oleic acid (18%), linoleic acid (55%), and linolenic acid (13%); Dosage: 1500 mg per day; Daily usage: 3 times a day; Duration of use: 12 weeks; How to use: orally 500 mg soft gel; After purchasing soybean oil, 500 mg soft gels are produced by Zahravi Pharmaceutical Company. Fasting blood sugar. Timepoint: At the beginning of the study (before the intervention) and at the end of the study. Method of measurement: Glucose oxidase assay. LDL cholesterol. Timepoint: At the beginning of the study (before the intervention) and at the end of the study. Method of measurement: Direct enzymatic method. High-sensitivity C-reactive Protein. Timepoint: At the beginning of the study (before the intervention) and at the end of the study. Method of measurement: Enzyme-Linked Immunosorbent Assay. Hemoglobin A1C. Timepoint: At the beginning of the study (before the intervention) and at the end of the study. Method of measurement: Enzymatic assay. Total cholesterol. Timepoint: At the beginning of the study (before the intervention) and at the end of the study. Method of measurement: Enzymatic assay. Tumor necrosis factor-alpha. Timepoint: At the beginning of the study (before the intervention) and at the end of the study. Method of measurement: Enzyme-Linked Immunosorbent Assay. Interleukin-6. Timepoint: At the beginning of the study (before the intervention) and at the end of the study. Method of measurement: Enzyme-Linked Immunosorbent Assay. Interleukin-10. Timepoint: At the beginning of the study (before the intervention) and at the end of the study. Method of measurement: Enzyme-Linked Immunosorbent Assay. Malondialdehyde. Timepoint: At the beginning of the study (before the intervention) and at the end of the study. Method of measurement: Reactivity with thiobarbituric acid. Total antioxidant capacity. Timepoint: At the beginning of the study (before the intervention) and at the end of the study. Method of measurement: Colorimetric method. Vice Chancellor for Research, Kermanshah University of Medical Sciences Approved 2021-02-16 Ethics committee of Kermanshah University of Medical Sciences Faculty of Nutritional Sciences and Food Industry, next to Farabi hospital, Esar square, Kermanshah Kermanshah Kermanshah Iran (Islamic Republic of)