MULTI-CENTRIC, DOUBLE BLIND STUDY OF EMAMI BLENDED EDIBLE VEGETABLE OIL (EBEVO1) ON IMMUNITY

Abstract

Background: The composition of Emami Blended Vegetable Oil (EBEVO1) is refined soyabean oil (75% by wt) and refined rice bran oil (25% by wt) with add on vitamins such as A, C, D, E & omega 3 fatty acids in order to enrich its nutritional value. Vit. A is involved in the development of the immune system and plays regulatory roles in cellular immune responses and humoral immune processes. Vit. A has demonstrated a therapeutic effect in the treatment of various infectious diseases. Crucial immune organs need constant dietary intake to maintain Vit. A concentration. Vitamin C is important in all stressful conditions that are linked to inflammatory processes and involve immunity. Study objectives: The sponsor, M/s Emami Agrotech Pvt. Ltd., developed the Emami Blended Edible Vegetable Oil (EBEVO1) which was evaluated upon the user acceptability and efficacy parameters. The baseline data of the evaluating parameters was compared with the results obtained by the end of the study (90days). Trial Design: The study was a randomized, multicentric, double-blind and controlled. The clinical trial protocol, information sheets, and consent forms were approved by the Ethical Committee of the Independent Research Ethics Society. The study was conducted after receiving the consent from the Ethics Committee (March 15, 2019). The Investigators have strictly followed the Standard Operating Procedures (SOPs) for the study following the Good Clinical Practice (GCP) and adhered to the Declaration of Helsinki. He/she thoroughly examined the study participants in his/her specific centre(s). Result: The results are encouraging where Group - A Oil shows better results than Group – B Oil due to value addition through Vitamins. Conclusion: Emami Blended Vegetable Oil contains 5 essential nutrients such as vitamin A, C, D, E and Omega 3 that have already been clinically confirmed in numerous trials around the world. The special blend of added nutrients that enhance the metabolic functions to enhance immunity to prevent minor general disorders or infections.