]>
IRCT20180205038626N12 IRCT 2023-08-21 Rasht University of Medical Sciences effects of rice bran oil capsule on glycemic indices, antioxidant and inflammatory indicators patients with type 2 diabetes Evaluation of the effects of rice bran oil capsule on glycemic indices, antioxidant and inflammatory indicators patients with type 2 diabetes: Double-blinded randomized clinical trial 2023-09-06 anticipated 50 Complete https://irct.ir/trial/72119 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The method of sampling and randomization of the two-blind, parallel-group clinical trial study will be stratified block randomization. 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, Blinding description: Since the capsules containing rice bran oil and placebo have been tried to be completely similar to each other due to the similarity in taste, taste, aroma and smell, the patients receiving and the researchers providing the supplements are of the type of supplement that each participant receives. They will not be aware. 2 Type 2 diabetes mellitus. Intervention 1: Intervention group: patients with type 2 diabetes, for 12 weeks, in addition to the standard diet, which includes 53% carbohydrates, 17% protein, and 30% fat, a nutritional consultant will provide the patients with a capsule containing Rice bran oil is prescribed and they are asked to consume one capsule of rice bran oil daily. Intervention 2: Control group: patients with type 2 diabetes, for 12 weeks, in addition to the standard diet, which includes 53% carbohydrates, 17% protein, and 30% fat, a nutritional consultant will provide the patients with a placebo capsule. It is prescribed and they are asked to take a placebo capsule daily. 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 further information
public Zahra ahmadnia
Dr. Heshmat Hospital; Bayani St; Mosala Square; Rasht.
Rasht Iran (Islamic Republic of) 4193955588 +98 13 3361 8177 zahmadnia1365@gmail.com Rasht University of Medical Sciences scientific Marjan Mahdavi Roshan
Dr. Heshmat Hospital; Bayani St; Mosala Square; Rasht.
Rasht Iran (Islamic Republic of) 4193955588 +98 13 3361 8177 Marjanmahdavi60@gmail.com Rasht University of Medical Sciences Iran (Islamic Republic of) Patients with an age range of 20 to 70 years Patients diagnosed with type 2 diabetes under drug therapy Serum glucose greater than 110 mg/dL Hemoglobin A1C maximum 9% Body mass index in the range of 25-30 Not using vitamin and mineral supplements, antioxidants, fiber supplements, omega-3 No history of kidney disease, kidney stones, digestive diseases, gallstones, and autoimmune diseases No current consumption of alcohol Not taking insulin 20 years 70 years Both Change in the patient's disease treatment plan during the study Changing the type of drugs used, effective factors studied Reluctance to continue the study or cause any dissatisfaction regarding the taste of the oil or participation in the study E11 Type 2 diabetes mellitus Treatment - Other Treatment - Other Intervention group: patients with type 2 diabetes, for 12 weeks, in addition to the standard diet, which includes 53% carbohydrates, 17% protein, and 30% fat, a nutritional consultant will provide the patients with a capsule containing Rice bran oil is prescribed and they are asked to consume one capsule of rice bran oil daily. Control group: patients with type 2 diabetes, for 12 weeks, in addition to the standard diet, which includes 53% carbohydrates, 17% protein, and 30% fat, a nutritional consultant will provide the patients with a placebo capsule. It is prescribed and they are asked to take a placebo capsule daily. Serum lipid profile levels (triglycerides, total cholesterol, LDL-C and HDL-C). Timepoint: At the beginning of the study and 12 weeks later. Method of measurement: BT2000 device. Fasting blood sugar. Timepoint: At the beginning of the study and 12 weeks later. Method of measurement: BT2000 device. Serum insulin. Timepoint: At the beginning of the study and 12 weeks later. Method of measurement: BT2000 device. Glycosylated hemoglobin. Timepoint: At the beginning of the study and 12 weeks later. Method of measurement: ELISA device. Erythrocyte sedimentation rate. Timepoint: At the beginning of the study and 12 weeks later. Method of measurement: ELISA device. Prothrombin Time. Timepoint: At the beginning of the study and 12 weeks later. Method of measurement: ELISA device. Partial Thromboplastin Time. Timepoint: At the beginning of the study and 12 weeks later. Method of measurement: ELISA device. Adropin. Timepoint: At the beginning of the study and 12 weeks later. Method of measurement: ELISA device. Omentin-1. Timepoint: At the beginning of the study and 12 weeks later. Method of measurement: ELISA device. Glutathione peroxidase activity. Timepoint: At the beginning of the study and 12 weeks later. Method of measurement: ELISA device. Glutathione reductase activity. Timepoint: At the beginning of the study and 12 weeks later. Method of measurement: ELISA device. Superoxide dismutase activity. Timepoint: At the beginning of the study and 12 weeks later. Method of measurement: ELISA device. Catalase activity. Timepoint: At the beginning of the study and 12 weeks later. Method of measurement: ELISA device. Paraoxonase activity. Timepoint: At the beginning of the study and 12 weeks later. Method of measurement: ELISA device. Vitamin E. Timepoint: At the beginning of the study and 12 weeks later. Method of measurement: ELISA device. Xanthine oxidase activity. Timepoint: At the beginning of the study and 12 weeks later. Method of measurement: ELISA device. HS - C-reactive protein. Timepoint: At the beginning of the study and 12 weeks later. Method of measurement: ELISA device. Total antioxidant activity. Timepoint: At the beginning of the study and 12 weeks later. Method of measurement: ELISA device. Estimated Glomerular Filtration Rate. Timepoint: At the beginning of the study and 12 weeks later. Method of measurement: Laboratory formula-measurement. C-Peptide. Timepoint: At the beginning of the study and 12 weeks later. Method of measurement: ELISA device. Mean systolic and diastolic blood pressure. Timepoint: At the beginning of the study and 12 weeks later. Method of measurement: Pressure indicator. Body mass index. Timepoint: At the beginning of the study and 12 weeks later. Method of measurement: Centimeter and scales. Rasht University of Medical Sciences Approved 2023-07-26 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)