Effects of a supplement containing rice bran oil and fucoxanthin on lipid profile, inflammatory indicators, and clinical and biochemical cardiovascular parameters in patients with coronary artery disease: A randomized clinical trial

Determining the effect of capsules containing rice bran oil and fucoxanthin on lipid profile, inflammatory factors and clinical cardiovascular indicators in patients with coronary heart disease.

Clinical trial with a control group, with parallel groups, double-blind, randomized, phase 3 on 50 patients. The website http://www.randomization.com will be used for randomization.

Patients referred to Heshmat hospital, Rasht were randomly allocated into two intervention groups ( receiving a standard diet containing olive oil as the main fat source + consuming three capsules of rice bran oil and fucoxanthin daily) and control (receiving a standard diet containing olive oil as the main fat source + consuming three placebo capsules) will be included in the study. This study is double-blind and since the capsules containing rice bran oil and fucoxanthin and placebo will be completely similar to each other, and the patients receiving and the researchers providing the supplements will be blinded to the type of supplement.

The inclusion criteria: coronary artery blockage, no use of supplements, no history of kidney disease, no current consumption of alcohol. The exclusion criteria: change in the treatment plan and the type of effective drugs used in the study, unwillingness to continue the study or any dissatisfaction with the taste of the oil, etc.

Intervention group: receiving standard diet + consuming three capsules of rice bran oil and fucoxanthin daily for 12 weeks Control group: receiving a standard diet + taking three placebo capsules daily for 12 weeks

lipid profile, fasting blood sugar level, inflammatory and antioxidant markers, and left ventricular ejection fraction

Due to observing beneficial effects and no side effects from administering 30 grams per day of rice bran oil and 1 gram per day of rice bran oil capsules in previous clinical trial projects of the current group (whose articles have been published), it has been decided in this study to increase the amount of oil to 3 grams per day.

The method of sampling and randomization of this two parallel double-blind clinical trial study, will be using the stratified block randomization method. At first, the participants will be classified into two groups according to their age (20 to 45 years and between 45 to 70 years), and then each person will randomly assigned to the intervention or control group using blocks of 4 randomly at a ratio of 1:1. One of the letters A or B will be assigned to each group.For randomization, the website http://www.randomization.com/ will be used. The list of codes obtained from this website will be provided to the researchers, and every referring patient who meets the inclusion criteria and does not meet the exclusion criteria and is willing to participate in the research, is first entered in the desired age group and in order Based on the assigned code, A or B enters the plan

Since the capsules containing rice bran oil and fucoxanthin and placebo have been tried to be completely similar to each other due to the similarity in taste, aroma and smell, the patients receiving and the researchers providing the supplements of the type of supplement that each participant receives will not find awareness.