The impact of a blend of Pistacia atlantica seed and canola oil compared with a blend of corn-canola oil with synthetic antioxidant and corn-canola oil without synthetic antioxidant on oxidative stress markers in patients with metabolic syndrome: protocol for a triple-blind, randomized, three-way cross-over clinical trial

Trials

Study Protocol

Fatemeh Pourrajab¹  Sara Jambarsang²  Solaleh Emamgholipour³  Ahmad Esmaillzadeh⁴  Bita Forootani⁵  Faezeh Zademohammadi⁵  Sayyed Saeid Khayyatzadeh⁵  Arezoo sadat Emrani⁵  Bahareh Sasanfar⁶  Amin Salehi-Abarghouei⁷  Seyed Ali Yasini Ardakani⁸ 

[1] Department of Biochemistry and Molecular Biology, School of Medicine, Shahid Sadoughi University of Medical Sciences, Yazd, Iran;Department of Biostatistics and Epidemiology, School of Public Health, Shahid Sadoughi University of Medical Sciences, Yazd, Iran;Department of Clinical Biochemistry, School of Medicine, Tehran University of Medical Sciences, Tehran, Iran;Department of Community Nutrition, School of Nutritional Sciences and Dietetics, Tehran University of Medical Sciences, Tehran University of Medical Sciences, P.O. Box 14155-6117, Tehran, Iran;Obesity and Eating Habits Research Center, Endocrinology and Metabolism Molecular Cellular Sciences Institute, Tehran University of Medical Sciences, Tehran, Iran;Research Center for Food Hygiene and Safety, School of Public Health, Shahid Sadoughi University of Medical Sciences, Yazd, Iran;Department of Nutrition, School of Public Health, Shahid Sadoughi University of Medical Sciences, Yazd, Iran;Research Center for Food Hygiene and Safety, School of Public Health, Shahid Sadoughi University of Medical Sciences, Yazd, Iran;Department of Nutrition, School of Public Health, Shahid Sadoughi University of Medical Sciences, Yazd, Iran;Cancer Research Center, Cancer Institute of Iran, Tehran University of Medical Sciences, Tehran, Iran;Research Center for Food Hygiene and Safety, School of Public Health, Shahid Sadoughi University of Medical Sciences, Yazd, Iran;Department of Nutrition, School of Public Health, Shahid Sadoughi University of Medical Sciences, Yazd, Iran;Yazd Cardiovascular Research Center, Non-communicable Diseases Research Institute, Shahid Sadoughi University of Medical Sciences, Yazd, Iran;Research center of food and confectionary, Yazd branch, Islamic Azad University, Yazd, Iran;

关键词: Pistacia atlantica;    Corn oil;    TBHQ;    Metabolic syndrome;    Antioxidant;    Oxidative stress;   

DOI  :  10.1186/s13063-023-07269-1

 received in 2022-05-24, accepted in 2023-03-21,  发布年份 2023

来源: Springer

【 摘 要 】

BackgroundMetabolic syndrome (MetS) is regarded as a complex metabolic disorder. Recently, the role of dietary antioxidants in the underlying pathogenesis and complications of MetS has come into focus. Pistacia atlantica oil is known as a high antioxidant oil which might improve the antioxidant status of dietary oils and also oxidative stress markers. On the other hand, tert-Butylhydroquinone (TBHQ) is an approved food-grade synthetic antioxidant that acts both as an inducer and inhibitor of carcinogenesis. The current trial will explore the possible effect of a blend of Pistacia atlantica seed-canola oils, corn-canola oils with TBHQ, and corn-canola oil without TBHQ on oxidative stress markers in patients with MetS.MethodsWe will conduct a single-center, triple-blind, three-way randomized cross-over clinical trial (RCT) among 72 patients with MetS. After a 1-month run-in period, eligible participants will consume the intervention oils as their regularly consumed oils in a random order. Each intervention period will last 8 weeks separated by 4-week washout periods. Anthropometric indices, body composition, physical activity, blood pressure, and 24-h dietary food recall measurements will be assessed at the beginning and the end of each intervention period. The primary outcome will be oxidative stress markers including serum total antioxidant capacity, total oxidant status, malondialdehyde, nitric oxide, and the enzyme activity of myeloperoxidase, superoxide dismutase, catalase, glutathione peroxidase, and glutathione reductase. The secondary outcomes will be changes in MetS components including blood pressure, fasting blood glucose, triglyceride, high-density lipoprotein cholesterol, and anthropometric measurements.DiscussionPistacia atlantica seed oil is high in antioxidants. An intervention with this oil could offer an option for oxidative stress prevention among patients with metabolic syndrome. The present clinical trial will be the first one assessing the impact of Pistacia atlantica oil on human oxidative stress markers.Trial registrationIranian Registry of Clinical trials IRCT20130223012571N8. Registered on 4 March 2022.

【 授权许可】

CC BY   
© The Author(s) 2023

【 图 表 】

Fig. 2