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IRCT20220108053663N1 IRCT 2022-10-09 Arak University of Medical Sciences Investigating the effect of Spirulina platensis algae in the treatment of diabetes Survey and Comparison of the effect of fortified yogurt enriched with fermented and non-fermented Spirulina Platensis extract on reducing oxidative stress in patients with type 2 diabetes mellitus 2022-09-21 anticipated 100 Complete https://irct.ir/trial/65709 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Other design features: In this study, spirulina algae is fermented and the effect of fermented type of algae is compared with non-fermented algae, Randomization description: This study is a double-blind randomized clinical trial study, which was considered by the diabetes clinic affiliated to Arak University of Medical Sciences to select patients with type 2 diabetes in the age group of 40-70 years. After voluntarily choosing 100 patients to participate in the study and providing explanations about the goals of the project and after obtaining their informed consent to participate in the study, a list of participants is prepared and coded. And the codes are entered in SPSS statistical software and using simple randomization method, people are divided into two groups of 50 people, Blinding description: The intervention is a type of double-blind randomized clinical trial. None of the participants and examiners will know about the allocation of groups to the intervention under study. The intended intervention is similar in terms of appearance (smell, color, appearance, etc.). N/A Type 2 diabetes mellitus. Intervention 1: Intervention group: After the patients visited the diabetes clinic for the plan, full explanations about the objectives of the study will be given to them during a one-hour training session. Then, after obtaining their informed written permission and consent to voluntarily participate in the study, people are randomly divided into two groups of 50 people, 50 type 2 diabetic patients, daily 200 grams of low-fat yogurt containing 20 grams of non-fermented spirulina algae powder. It is suggested that the patient consumes 100 grams of yogurt in two meals for 21 days. Algae powder manufacturer is Berkeh Sabz Mad Asia Company, and it is one of the factories in the country and has a health license from the Vice-Chancellor of Food and Medicine of Arak University of Medical Sciences. Intervention 2: Intervention group: After the patients visited the diabetes clinic for the plan, full explanations about the objectives of the study will be given to them during a one-hour training session. Then, after obtaining their informed written permission and consent to voluntarily participate in the study, people are randomly divided into two groups of 50 people, 50 type 2 diabetic patients, daily 200 grams of low-fat yogurt containing 20 grams of fermented spirulina algae powder. It is suggested that the patient consumes 100 grams of yogurt in two meals for 21 days. Algae powder manufacturer is Berkeh Sabz Mad Asia Company, and it is one of the factories in the country and has a health license from the Vice-Chancellor of Food and Medicine of Arak University of Medical Sciences. Yes - There is a plan to make this available What will be shared: The individual information of the participants without the names of the people, the spss file includes the results of fasting blood sugar, malondialdehyde, glutathione regeneration and the total antioxidant level of the blood serum of the patients can be shared. Statistical tests cannot be delegated. When: starting in september 2023 To whom: Researchers working in academic and scientific institutions Conditions: No special conditions are required. Where to obtain: Refer to the email below. aida_gh60@yahoo.com How to obtain: Two weeks after submitting the application Comments:
public Anoosheh Sharifan
Science and Research branch, Islamic Azad University
tehran Iran (Islamic Republic of) 1477893855 +98 21 4486 5154 a_sharifan2000@yahoo.com Islamic Azad University scientific Ayda Ghaffari
no108- Sefid Tower, Mirza Shirazi street
Arak Iran (Islamic Republic of) 3815937458 +98 86 3276 0036 AIDA_GH60@YAHOO.COM Arak University of Medical Sciences Iran (Islamic Republic of) Type 2 diabetes mellitus 40 years 70 years Both Type1 diabetes mellitus Patients injecting insulin Age less than 40 and more than 70 years E08 Diabetes mellitus due to underlying condition Treatment - Other Treatment - Other Intervention group: After the patients visited the diabetes clinic for the plan, full explanations about the objectives of the study will be given to them during a one-hour training session. Then, after obtaining their informed written permission and consent to voluntarily participate in the study, people are randomly divided into two groups of 50 people, 50 type 2 diabetic patients, daily 200 grams of low-fat yogurt containing 20 grams of non-fermented spirulina algae powder. It is suggested that the patient consumes 100 grams of yogurt in two meals for 21 days. Algae powder manufacturer is Berkeh Sabz Mad Asia Company, and it is one of the factories in the country and has a health license from the Vice-Chancellor of Food and Medicine of Arak University of Medical Sciences. Intervention group: After the patients visited the diabetes clinic for the plan, full explanations about the objectives of the study will be given to them during a one-hour training session. Then, after obtaining their informed written permission and consent to voluntarily participate in the study, people are randomly divided into two groups of 50 people, 50 type 2 diabetic patients, daily 200 grams of low-fat yogurt containing 20 grams of fermented spirulina algae powder. It is suggested that the patient consumes 100 grams of yogurt in two meals for 21 days. Algae powder manufacturer is Berkeh Sabz Mad Asia Company, and it is one of the factories in the country and has a health license from the Vice-Chancellor of Food and Medicine of Arak University of Medical Sciences. Average changes in reduced glutathione levels in the blood serum of type 2 diabetics. Timepoint: Measurement of blood reduced glutathione levels before the intervention and 21 days after the intervention. Method of measurement: reduced glutathione blood level measurement kit. Average changes in fasting blood sugar levels in the blood serum of type 2 diabetics. Timepoint: Measurement of fasting blood sugar before the intervention and 21 days after the intervention. Method of measurement: fasting blood sugar measurement kit. Average changes in high reactive protein C level in blood serum of type 2 diabetic patients. Timepoint: Measurement of C protein with high reactivity in blood serum before the intervention and 21 days after the intervention. Method of measurement: C- Reactive protein measurement kit. Malondialdehyde( MDA). Timepoint: Malondialdehyde content is measured before and 21 days after consumption of yogurt enriched with fermented and non-fermented Spirulina Platensis. Method of measurement: diagnostic malondialdehyde assay kit. Ferric Reducing Ability of Plasma( FRAP). Timepoint: Before starting consumption and 21 days after starting consumption of yogurt enriched with fermented and non-fermented spirulina platensis, the antioxidant capacity of total plasma is measured. Method of measurement: FRAP Detection Assay Kit. Arak Medical University Approved 2022-08-22 Ethics Committee of Islamic Azad University Science and Research Unit Islamic Azad University, Department of Science and Research - Sattari Blvd Tehran Tehran Iran (Islamic Republic of)