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

Determination of the effects of rice bran oil capsule on glycemic indices, antioxidant and inflammatory indicators patients with type 2 diabetes

Clinical trial with control group, with parallel groups, double-blind, randomized, phase 2 on 50 patients to allocate consumption to the subjects will use the randomized block method. The website http://www.randomization.com will also be used for randomization.

Fifty patients with type 2 diabetes referred to the outpatient clinic of Razi Medical Education Center in Rasht. With personal consent, they will enter the study after completing the informed consent form, taking into account the entry and exit criteria. Patients in two groups of twenty-five will be subjected to intervention with one capsule containing one gram of rice bran oil along with a standard diet, and the control group will be given a placebo capsule along with a standard diet. The sampling method will be easy.

Inclusion criteria: patients diagnosed with type 2 diabetes under drug therapy in the age range of 20 to 70 years, serum glucose more than 110 mg/dL , body mass index in the range of 25-30, hemoglobin E1C maximum 9%.Exclusion criteria: use of insulin, use of vitamin and mineral supplements, antioxidants, fiber supplements, omega-3, history of kidney disease, kidney stones, digestive diseases, gallstones, autoimmune diseases, Current consumption of alcohol

Intervention group: Patients with type 2 diabetes will be prescribed one capsule containing one gram of rice bran oil daily for 12 weeks in addition to the standard diet that includes 53% carbohydrates, 17% protein and 30% fat. Control: Patients with type 2 diabetes are prescribed a placebo capsule daily for 12 weeks in addition to the standard diet.

Glycemic, antioxidant and inflammatory control indicators

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.

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.