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

Determining the effects of rice bran oil administration on the indicators of metabolic syndrome, inflammatory status and the ratio of apolipoproteins A1 to B100 in adult patients with metabolic syndrome

Clinical trial with control group, with parallel groups, without blinding, 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 metabolic syndrome referred to the outpatient clinic of Dr. Heshmat Heart Training Center will be admitted with personal consent after completing the informed consent form, taking into account the inclusion and exclusion criteria. Patients in two groups of 25 will be treated with rice bran oil (2 tablespoons daily) and standard diet or standard diet with 30 grams or 2 tablespoons per day of sunflower oil (as a control group).

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 ,Current consumption of alcohol

Intervention group: Patients 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 are asked to consume 30 grams of sunflower oil, which is equivalent to 2 tablespoons of oil prepared from authorized stores, along with lunch.

Cardiovascular risk factors

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.

Information on the main outcome

Access period starts 6 months after the results are published

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Zeynab Ghorbany Lohesara

By email to dr.zeynab ghorbani lohesara