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IRCT20180205038626N10 IRCT 2021-11-25 Rasht University of Medical Sciences Evaluation of the effects of rice bran oil administration on metabolic syndrome components, inflammatory condition and Apo A1 to Apo B100 ratio in adult patients with metabolic syndrome Evaluation of the effects of rice bran oil administration on metabolic syndrome components, inflammatory condition and Apo A1 to Apo B100 ratio in adult patients with metabolic syndrome: An Open Label Randomized Controlled Trial 2021-11-22 anticipated 50 Complete https://irct.ir/trial/60160 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: Sampling and randomization The clinical trial study of two parallel groups of open label will be classified by block random sampling method. At first, participants were classified into two classes according to age (20 to 45 years and between 45 to 70 years) and then each person was randomly assigned to the intervention or control group using 1: 4 random blocks. Took. In this method, each group will be assigned one of the letters A or B. The website will also be used for randomization. The list of codes obtained from this website will be provided to the researchers, and each referring patient who met the inclusion criteria and did not meet the inclusion criteria and was willing to participate in the study, first entered the desired age group and based on The assigned code A or B enters the design. For concealment, in this study, random allocation concealment, which is the method used to execute a random sequence on the study participants, will be used in such a way that the assigned group is not known before the individual is assigned. In this way, using opaque envelopes sealed with a random sequence, in this method, each of the random sequences created is recorded on a card and the cards are placed inside the envelopes in order. In order to maintain a random sequence, the envelopes are numbered in the same way on the outer surface. Finally, the lids of the letter envelopes are glued and placed inside a box, respectively. At the beginning of the registration of participants, based on the order of entry of eligible participants into the study, one of the envelopes of the letter is opened in order and the assigned group of the participant is revealed. 2 Metabolic syndrome. Intervention 1: Intervention group: Patients with metabolic syndrome will be included in the study for 8 weeks to receive a standard diet + consumption of 30 grams of rice bran oil per day. Patients in the intervention group are asked to consume 30 grams of rice bran oil, which is equivalent to 2 tablespoons of bran oil prepared by Giltaz Company, along with lunch. Intervention 2: Control group: Patients in the control group are also asked to consume 30 grams of sunflower oil, which is equivalent to 2 tablespoons of oil prepared from authorized stores, along with lunch. Oils are given to all patients in a graduated dose and they are asked to add 30 grams of it daily in a graduated dose to their salad or cooked food at lunch. Yes - There is a plan to make this available What will be shared: Information on the main outcome When: Access period starts 6 months after the results are published To whom: Researchers working in academic institutions Conditions: Request to receive unidentifiable personal data or other documents Where to obtain: Zeynab Ghorbany Lohesara How to obtain: By email to dr.zeynab ghorbani lohesara Comments:
public Zahra Ahmadnia
Dr. Heshmat Hospital; Bayani St; Mosala Square; Rasht.
Rasht Iran (Islamic Republic of) 4193955588 +98 13 3361 8177 zahmadnia@gums.ac.ir Rasht University of Medical Sciences scientific Zeynab Ghorbani lohesara
Dr. Heshmat Hospital; Bayani St; Mosala Square; Rasht
Rasht Iran (Islamic Republic of) 4193955588 +98 41 9395 5588 z.ghorbani.h@gmail.com Rasht University of Medical Sciences Iran (Islamic Republic of) Patients with an age range of 20 to 70 years Patients with metabolic syndrome Do not use vitamin and mineral supplements, antioxidants, fiber supplements, omega 3 No history of kidney disease, kidney stones, gastrointestinal diseases, gallstones, and autoimmune diseases No current consumption of alcohol 20 years 70 years Both Changes in the patient's treatment plan during the study Changing the type of effective drugs used factors studied Reluctance to continue the study or to cause any dissatisfaction with the taste of the oil or to participate in the study E88.81 Metabolic syndrome Prevention Prevention Intervention group: Patients with metabolic syndrome will be included in the study for 8 weeks to receive a standard diet + consumption of 30 grams of rice bran oil per day. Patients in the intervention group are asked to consume 30 grams of rice bran oil, which is equivalent to 2 tablespoons of bran oil prepared by Giltaz Company, along with lunch. Control group: Patients in the control group are also asked to consume 30 grams of sunflower oil, which is equivalent to 2 tablespoons of oil prepared from authorized stores, along with lunch. Oils are given to all patients in a graduated dose and they are asked to add 30 grams of it daily in a graduated dose to their salad or cooked food at lunch. Serum lipid profile levels (triglycerides, total cholesterol, LDL-C and HDL-C). Timepoint: At the beginning of the study and 8 weeks later. Method of measurement: BT2000 devices. Serum levels of Apo A1 and Apo B100. Timepoint: At the beginning of the study and 8 weeks later. Method of measurement: Nefrometric devices. Fasting blood sugar. Timepoint: At the beginning of the study and 8 weeks later. Method of measurement: BT2000 devices. CRP. Timepoint: At the beginning of the study and 8 weeks later. Method of measurement: ELISA Devices. D-dimer. Timepoint: At the beginning of the study and 8 weeks later. Method of measurement: ELISA Device. Mean systolic blood pressure. Timepoint: At the beginning of the study and 8 weeks later. Method of measurement: Pressure indicator. Mass Index body. Timepoint: At the beginning of the study and 8 weeks later. Method of measurement: Centimeter and scales. Waist. Timepoint: At the beginning of the study and 8 weeks later. Method of measurement: Centimeter. Mean diastolic blood pressure. Timepoint: At the beginning of the study and 8 weeks later. Method of measurement: Pressure indicator. Rasht University of Medical Sciences Approved 2021-11-10 Ethics committee of Guilan University of Medical Sciences Technology & Research Vice-chancellor of University; Shahid Siadati St; Namjoo St., Rasht Rasht Guilan Iran (Islamic Republic of)