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IRCT20210407050880N1 IRCT 2021-12-25 Tabriz University of Medical Sciences Effect of Fenugreek Seed Extract on inflammation in Patients with Type 2 Diabetes The Effect of Fenugreek Seed Extract Supplementation on Body Composition, Blood Pressure, IL-1β, Adiponectin, and Depression in Patients with Type 2 Diabetes: Randomized Double-Blind Controlled Clinical Trial 2021-08-06 anticipated 46 Complete https://irct.ir/trial/56040 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Subjects are randomly divided into two groups of 23 people, by application of RAS software (Random allocation software) and using block randomization method according to the classification on body mass index (30-25 or 35-30 kg/m2) and gender (male or female), and in the form of 4 groups and blocks of 2 people, Blinding description: For being double-blind research, at the beginning of the study, the boxes of capsules will be coded in A and B by someone other than the researcher, so that the researcher and patients won't be informed about the type of capsules received by each group. 3 Type 2 Diabetes. Intervention 1: Intervention group: Dry extract of fenugreek seeds of Barij Essence Company entitled "Glucorx B" (containing 46.4 micrograms of luteolin per tablet), in the form of three 335 mg tablets and diet for eight weeks. This study's population 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 each patient's clinical condition; Therefore, reducing calories per person will not be a fixed amount. BMR (using the Mifflin formula) will be multiplied by physical activity and TEF to calculate calories. People in this group will be on a diabetic and calorie-restricted diet. The relevant menu will be taught to patients, along with nutritional recommendations. Intervention 2: Control group: This group will take three 335 mg placebo tablets, made of microcrystalline cellulose, prepared by Barij Essence Company and diet for eight weeks. This study's population 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 each patient's clinical condition; Therefore, reducing calories per person will not be a fixed amount. BMR (using the Mifflin formula) will be multiplied by physical activity and TEF to calculate calories. People in this group will be on a diabetic and calorie-restricted diet. The relevant 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 Laleh Fakhr
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 lalehfakhrnut@gmail.com Tabriz University of Medical Sciences scientific Laleh Fakhr
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 lalehfakhrnut@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 Essence Company entitled "Glucorx B" (containing 46.4 micrograms of luteolin per tablet), in the form of three 335 mg tablets and diet for eight weeks. This study's population 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 each patient's clinical condition; Therefore, reducing calories per person will not be a fixed amount. BMR (using the Mifflin formula) will be multiplied by physical activity and TEF to calculate calories. People in this group will be on a diabetic and calorie-restricted diet. The relevant menu will be taught to patients, along with nutritional recommendations. Control group: This group will take three 335 mg placebo tablets, made of microcrystalline cellulose, prepared by Barij Essence Company and diet for eight weeks. This study's population 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 each patient's clinical condition; Therefore, reducing calories per person will not be a fixed amount. BMR (using the Mifflin formula) will be multiplied by physical activity and TEF to calculate calories. People in this group will be on a diabetic and calorie-restricted diet. The relevant menu will be taught to patients, along with nutritional recommendations. Inflammatory marker IL-1β. Timepoint: Before intervention and 2 months after intervention. Method of measurement: Measurement of serum level by ELISA kit. Adiponectin. Timepoint: Before intervention and 2 months after intervention. Method of measurement: Measurement of serum level by ELISA kit. ‌‌Body Composition. Timepoint: Before intervention and 2 months after intervention. Method of measurement: By Tanita Body Analyzer. Blood pressure. Timepoint: Before intervention and 2 months after intervention. Method of measurement: Mercury barometer. Depression. Timepoint: Before intervention and 2 months after intervention. Method of measurement: PHQ-9 questionnaire. Tabriz University of Medical Sciences Approved 2021-08-02 Ethics committee of Tabriz University of Medical Sciences Faculty of Nutrition - Tabriz University of Medical Sciences - Golgasht St. - Attar Neyshabouri St. - Tabriz - Iran Tabriz East Azarbaijan Iran (Islamic Republic of)