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IRCT20191126045515N1 IRCT 2020-07-18 Shiraz University of Medical Sciences Investigating the effect of spirulina algae in type 2 diabetes Investigating the effect of sauce prepared with spirulina algae on anthropometric indicators, glycemic markers, lipid profile, malondialdehyde and appetite in patients with type 2 diabetes: a double-blind clinical trial 2019-12-31 anticipated 46 Complete https://irct.ir/trial/43859 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization based on the method of reversible blocks In this scheme, randomization based on the method of reversible blocks is carried out In the way that 4 blocks will be created. These blocks are then randomly placed in two rows, male and female. Through classifying blocks by the gender, at the end of sampling we will have an equal number of male and female participants in both groups (A and B), thereby modifying the effect of gender distortion, Blinding description: In this study, the first step is to allocate a specific pilot that will be used to produce products containing Spirulina and without Spirulina in a factory and will be monitored by the project scientific consultant (food industry specialist) and the researcher to ensure optimal production conditions. After that, the factory is asked to produce a sufficient number of products in the same packaging and different labels A or B. Consultant of the project and production manager are the only people who are aware of the type of packaged products. As a result, the researcher and participants will be blinded. The products are delivered from the factory after production and are given to the patients immediately. In order to concealment, all code predicted by random allocation software is placed in pockets respectively. Pockets related to a women's accidental block are placed in the first box and pockets related to a men's accidental block are placed in the second box. The lids of the boxes are designed so that only the top pocket can be removed each time. The first pocket taken from the women's box will be assigned to the first female client, who will determine which group (A or B) this person will be after opening. The same goes for men. By doing so, the researcher cannot predict which group the next clients will fall into and the interviewer's bias will be curbed. 3 Type 2 diabetes mellitus. Intervention 1: Intervention group: The group receiving the spirulina algae sauce would use the sauce containing 2 grams of Spirulina per day up to 2 months. The products were produced in Tiondasht Keshto Sanaat company. Intervention 2: Control group: The group receiving the sauce without Spirulina algae. Yes - There is a plan to make this available What will be shared: I haven't decided yet. The release schedule is not clear yet. When: I haven't decided yet. The release schedule is not clear yet. To whom: I haven't decided yet. The release schedule is not clear yet. Conditions: I haven't decided yet. The release schedule is not clear yet. Where to obtain: I haven't decided yet. The release schedule is not clear yet. How to obtain: I haven't decided yet. The release schedule is not clear yet. Comments:
public Mojtaba Rezaiyan
School of Nutrition and Food Science, Fatholmobin alley, Razi blvd
Shiraz Iran (Islamic Republic of) 7153675541 +98 71 3725 1001 mrezaiyan0@gmail.com Shiraz University of Medical Sciences scientific Mojtaba Rezaiyan
School of Nutrition and Food Science, Fatholmobin alley, Razi blvd
Shiraz Iran (Islamic Republic of) 7153675541 +98 71 3725 1001 mrezaiyan0@gmail.com Shiraz University of Medical Sciences Iran (Islamic Republic of) Patients with type 2 diabetes (doctor's diagnosis) Fasting blood sugar higher than 130 Not using insulin Age between 30 and 60 years 30 years 60 years Both Suffering from cardiovascular, liver, kidney and thyroid disorders Specific medical conditions that require specific diet and exercise changes Participate in other studies over the past 6 months Use any supplements or specific diets Pregnancy and lactation Alcohol consumption and smoking E08 Diabetes mellitus due to underlying condition Treatment - Other Placebo Intervention group: The group receiving the spirulina algae sauce would use the sauce containing 2 grams of Spirulina per day up to 2 months. The products were produced in Tiondasht Keshto Sanaat company Control group: The group receiving the sauce without Spirulina algae Fasting blood sugar. Timepoint: Before and after intervention. Method of measurement: By the means of Pars Azmoon Company kit and auto analyzer. Insulin. Timepoint: Before and after intervention. Method of measurement: By Diameter Company Kit. Hemoglobin A1c. Timepoint: Before and after intervention. Method of measurement: By diazyme kit. Insulin resistance. Timepoint: Before and after intervention. Method of measurement: With Homeostatic Model Assessment for Insulin Resistance index and formula. Appetite. Timepoint: Before and after intervention. Method of measurement: With Visual analogue scales questionnaire. Serum lipid profile. Timepoint: Before and after intervention. Method of measurement: By the means of Pars Azmoon Company kit and auto analyzer. Malondialdehyde. Timepoint: Before and after intervention. Method of measurement: Thiobarbituric acid method. Weight. Timepoint: Before and after intervention. Method of measurement: Digital scales. Body composition. Timepoint: Before and after the intervention. Method of measurement: Bioelectric impedance analysis. Shiraz University of Medical Sciences Approved 2019-08-06 Ethics committee of Shiraz University of Medical Sciences Dastgheib Dormitory, Eram Square Shiraz Fars Iran (Islamic Republic of)