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IRCT20210407050881N1 IRCT 2022-01-04 Tabriz University of Medical Sciences Effect of fenugreek seed extract on oxidative stress in type 2 diabetic patients The Effect of Fenugreek Seed Extract Supplementation on Blood glucose,Lipid profile, Appetite, Energy Intake and Macronutrient, Oxidative stress in Patients with Type 2 Diabetes:Randomized Double-blind Controlled clinical Trial 2021-08-06 anticipated 46 Complete https://irct.ir/trial/56128 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Subjects using RAS software (Random allocation software) and randomly, using the method of random blocking (block randomization) in terms of classification on body mass index (25-30 or 35-30 kg / m2) And gender (female or male) and inclusion in the study in the form of 4 groups and blocks with size of 6 , are divided into 2 groups of 23 people, Blinding description: For double-blind research, at the beginning of the study, a set of cans containing the corresponding capsule, which are similar in appearance (color, odor, size, shape), are coded A and B by someone other than the researcher until the researcher is informed. And patients of the type of capsules received by each group.The drug and placebo were similar in characteristics and appearance (color, odor, size). 3 Type 2 diabetes mellitus. Intervention 1: Intervention group: Dry extract of fenugreek seeds of Barij Essential Oil Company called "Glucorx B" (containing 46.4 micrograms of luteolin per tablet) will be consumed in the form of three 335 mg tablets. The study population in this study is people with type 2 diabetes who need to receive diet and nutritional advice due to ethical considerations. According to the available reference (Krause), the prescribed regimen should be appropriate to the clinical condition of each patient; Therefore, the amount of reduction in calories per person will not be a fixed amount. To calculate calories, BMR (using the Myfeline formula) will be multiplied by physical activity and TEF. People in this group are on a diabetic and calorie-restricted diet for 8 weeks. The relevant food menu will be taught to patients along with nutritional recommendations. Intervention 2: Control group: will consume three 335 mg placebo tablets made of microcrystalline cellulose prepared by Barij Essential Oil Company. The study population in this study is people with type 2 diabetes who need to receive diet and nutritional advice due to ethical considerations. According to the available reference (Krause), the prescribed regimen should be appropriate to the clinical condition of each patient; Therefore, the amount of reduction in calories per person will not be a fixed amount. To calculate calories, BMR (using the Myfeline formula) will be multiplied by physical activity and TEF. People in this group are on a diabetic and calorie-restricted diet for 8 weeks. The relevant food menu will be taught to patients along with nutritional recommendations. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no more information
public Fatemeh Chehregosha
Faculty of Nutrition - Tabriz University of Medical Sciences - Golgasht St. - Attar Neyshabouri St. - Tabriz - Iran
Tabriz Iran (Islamic Republic of) 5166616471 +98 41 3335 5921 fatemehchehregosha4@gmail.com Tabriz University of Medical Sciences scientific Fatemeh Chehregosha
Faculty of Nutrition - Tabriz University of Medical Sciences - Golgasht St. - Attar Neyshabouri St. - Tabriz - Iran
Tabriz Iran (Islamic Republic of) 5166616471 +98 41 3335 5921 fatemehchehregosha4@gmail.com Tabriz University of Medical Sciences Iran (Islamic Republic of) Patients in the age range of 30-65 years Having at least 6 months of diabetes history (according to criteria of American Diabetes Association) BMI between 25 and 35 Taking blood sugar lowering drugs No herbs at least 3 months before the study to be used routinely Willingness to participate in the project 30 years 65 years Both Pregnancy or breastfeeding or its intention Kidney, liver, gastrointestinal, thyroid, and rheumatic diseases Allergy to plants of the Fabaceae family E11 Type 2 diabetes mellitus Treatment - Drugs Placebo Intervention group: Dry extract of fenugreek seeds of Barij Essential Oil Company called "Glucorx B" (containing 46.4 micrograms of luteolin per tablet) will be consumed in the form of three 335 mg tablets. The study population in this study is people with type 2 diabetes who need to receive diet and nutritional advice due to ethical considerations. According to the available reference (Krause), the prescribed regimen should be appropriate to the clinical condition of each patient; Therefore, the amount of reduction in calories per person will not be a fixed amount. To calculate calories, BMR (using the Myfeline formula) will be multiplied by physical activity and TEF. People in this group are on a diabetic and calorie-restricted diet for 8 weeks. The relevant food menu will be taught to patients along with nutritional recommendations. Control group: will consume three 335 mg placebo tablets made of microcrystalline cellulose prepared by Barij Essential Oil Company. The study population in this study is people with type 2 diabetes who need to receive diet and nutritional advice due to ethical considerations. According to the available reference (Krause), the prescribed regimen should be appropriate to the clinical condition of each patient; Therefore, the amount of reduction in calories per person will not be a fixed amount. To calculate calories, BMR (using the Myfeline formula) will be multiplied by physical activity and TEF. People in this group are on a diabetic and calorie-restricted diet for 8 weeks. The relevant food menu will be taught to patients along with nutritional recommendations. Fasting blood suger. Timepoint: Before intervention and 2 months after intervention. Method of measurement: Measurement of blood levels using electrochemical methods. Serum insulin. Timepoint: Before intervention and 2 months after intervention. Method of measurement: Measurement of serum level by ELISA kit. Insulin resistance. Timepoint: Before intervention and 2 months after intervention. Method of measurement: Formula calculation. Triglyceride. Timepoint: Before intervention and 2 months after intervention. Method of measurement: Measurement of serum level using spectrophotometric method. LDL. Timepoint: Before intervention and 2 months after intervention. Method of measurement: Friedwald Computational Method. HDL. Timepoint: Before intervention and 2 months after intervention. Method of measurement: Measurement of serum level using spectrophotometric method. Total cholestrol. Timepoint: Before intervention and 2 months after intervention. Method of measurement: Measurement of serum level using spectrophotometric method. PAB. Timepoint: Before intervention and 2 months after intervention. Method of measurement: Measurement of serum level by ELISA kit. Appetite. Timepoint: Before intervention and 2 months after intervention. Method of measurement: questionnaire. Calorie intake. Timepoint: Before intervention and 2 months after intervention. Method of measurement: questionnaire(Finally, energy calculation using n4 software). Macronutrients intake. Timepoint: Before intervention and 2 months after intervention. Method of measurement: n4 software. Tabriz University of Medical Sciences Approved 2021-08-02 Ethics committee of Tabriz University of Medical Sciences Factulty of Nutrition, Tabriz University of Medical Sciences, Golgasht St, Attar Neyshabouri St., Tabriz Tabriz East Azarbaijan Iran (Islamic Republic of)