Evaluation of the effects of rice bran powder administration on cardiovascular risk factors in adult patients with metabolic syndrome: A Randomized Controlled Open Label Trial

Determining the effects of rice bran powder on cardiovascular risk factors 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 to the study 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 intervened with rice bran powder (15 grams per day equivalent to 1 tablespoon) and standard diet or standard diet alone (as a control group). The sampling method will be easy.

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 with metabolic syndrome will consume 15 grams of bran powder, which is equivalent to 1 tablespoon of bran powder prepared by Giltaz company, for 8 weeks, along with their lunch or salad with rice. Control group: Patients with metabolic syndrome will be prescribed only a standard diet for 8 weeks. According to the formula, a standard diet consisting of 55 Percent carbohydrates, 18 Percent protein and 27 Percent fat will be provided to patients by a nutrition consultant.

Lipid Profiles (Triglycerides, Total Cholesterol, LDL-C and HDL-C) Apo A1 and Apo B100 fasting blood sugar CRP D-dimer

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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Marjan Mahdavi Roshan

By email to Dr.Marjan Mahdavi Roshan