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IRCT20231104059958N1 IRCT 2023-11-19 Faculty of Veterinary Medicine, Shiraz University The effect of consuming the prepared cakes with acorn flour in patients with metabolic syndrome Comparison of the effect of consuming the prepared cakes with acorn flour and wheat flour following a hypocaloric diet on serum levels of adiponectin, inflammatory factors and oxidative stress parameters in obese and overweight patients with metabolic syndrome: a double-blind clinical trial 2022-06-22 anticipated 66 Complete https://irct.ir/trial/73597 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: After the 2-week run-in period, the patients will be randomly allocated to the intervention or placebo (control) group using the balanced block randomization method with a block size of 4. The treatment allocation will performed using software-generated random numbers. Patients in the intervention group will consume two daily servings (2×30 g) of AC (n= 33) as snacks for 8 weeks a day; while those in the control group will be assigned to equal amounts of PC (n= 33) for the same period. The cakes will be prepared in the city of Shiraz. The intervention and control cakes will be equal in terms of shape, size, color, and taste. Also, both cakes will be prepared with identical packages and labeled as A or B, so that both study personnel and participants are unaware of the type of treatment, Blinding description: Study participants, researchers, and laboratory personnel are blinded to group allocation until after the study. The designed placebo is completely similar to the intervention group in terms of color, smell, size and model. In order to blind the researcher, help is taken from a person who is not involved in the research process. The set of packs containing cakes prepared by a third party are coded as A and B. 3 Condition 1: Metabolic syndrome. Condition 2: Obesity due to excess calories. Intervention 1: Intervention group: the group that received the super-beneficial cake containing oak powder. The amount of calories in both oak and wheat cakes will be equal, so due to the higher calorie content of oak flour, 10 grams of sweetened oak flour should be used in preparing a cake containing oak flour, and 13.8 grams of wheat flour should be used in preparing a cake containing wheat flour. will be. Other ingredients of both cakes will be similar. A cake with an approximate weight of 30 grams will be produced and packaged in a standard way and will be considered as part of a snack to be consumed once a day by the patient. Intervention 2: Control group: The group receiving a cake containing wheat flour, a cake with an approximate weight of 30 grams will be produced and packaged in a standard way and will be considered as a part of the patient's snack to be consumed once a day. Yes - There is a plan to make this available What will be shared: Laboratory data can be published When: After studying To whom: For researchers and people working in industry Conditions: Use of data in industry is allowed Where to obtain: Hamed Sadeghi-dehsahraei - via email sadeghidehsahraiihamed@yahoo.com How to obtain: The possibility of applying by email will be checked and answered within two weeks Comments:
public hamed sadeghi-dehsahraei
Islamic Republic Blvd
shiraz Iran (Islamic Republic of) 71946-84334 +98 71 3613 8618 sadeghidehsahraiihamed@yahoo.com Faculty of Veterinary Medicine, Shiraz University scientific hamed sadeghi-dehsahraei
Islamic Republic Blvd
shiraz Iran (Islamic Republic of) 71946-84334 +98 71 3613 8618 sadeghidehsahraiihamed@yahoo.com Faculty of Veterinary Medicine, Shiraz University Iran (Islamic Republic of) Patients with metabolic syndrome Waist circumference greater than 102 cm in men and 88 cm in women Triglycerides equal to or greater than 150 mg/dL HDL less than or equal to 40 in men and less than or equal to 50 in women Blood pressure more than 130 to 85 mm Hg and blood sugar equal to or more than 100 mg/dL Stable body weight (weight change less than 3 kg in the last 3 months) Not participating in weight loss programs in the last 6 months 20 years 60 years Both Diabetic patients receiving blood sugar lowering drugs and insulin History of alcohol consumption Smoking Pregnant and lactating women People with mental illnesses, cancer, thyroid, cardiovascular, lung, kidney, liver, eating disorders Taking drugs that affect appetite, body weight, calcium and vitamin D metabolism, and lipid metabolism or have an anti-inflammatory effect. Taking antioxidants or multivitamins and any type of food supplement Having lactose intolerance E88.81 E66.0 Metabolic syndrome Obesity due to excess calories Treatment - Other Treatment - Other Intervention group: the group that received the super-beneficial cake containing oak powder. The amount of calories in both oak and wheat cakes will be equal, so due to the higher calorie content of oak flour, 10 grams of sweetened oak flour should be used in preparing a cake containing oak flour, and 13.8 grams of wheat flour should be used in preparing a cake containing wheat flour. will be. Other ingredients of both cakes will be similar. A cake with an approximate weight of 30 grams will be produced and packaged in a standard way and will be considered as part of a snack to be consumed once a day by the patient. Control group: The group receiving a cake containing wheat flour, a cake with an approximate weight of 30 grams will be produced and packaged in a standard way and will be considered as a part of the patient's snack to be consumed once a day. Interleukin-6. Timepoint: Before and after the intervention. Method of measurement: ELISA (Enzyme-Linked Immunosorbent Assay ) kit. C reactive protein. Timepoint: Before and after the intervention. Method of measurement: ELISA (Enzyme-Linked Immunosorbent Assay ) kit. Malondialdehyde. Timepoint: before and after the intervention. Method of measurement: Thiobarbituric acid method. Total antioxidant capacity. Timepoint: before and after the intervention. Method of measurement: ElISA (Enzyme-linked immunosorbent assay) kit. Adiponectin. Timepoint: before and after the intervention. Method of measurement: ElISA (Enzyme-linked immunosorbent assay) kit. Shiraz University of Medical Sciences Faculty of Veterinary Medicine, Shiraz University Shiraz university of medical sciences Approved 2023-10-14 Ethics Committee of Shiraz University Eram Blvd shiraz Fars Iran (Islamic Republic of)