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.
Trials. 2023 Jul 24;24(1):473. doi: 10.1186/s13063-023-07269-1.
Metabolic 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.
We 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.
Pistacia 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.
Iranian Registry of Clinical trials IRCT20130223012571N8 . Registered on 4 March 2022.
代谢综合征（MetS）被认为是一种复杂的代谢紊乱。最近，膳食抗氧化剂在 MetS 的潜在发病机制和并发症中的作用引起了关注。阿月浑子油是一种已知的高抗氧化油，它可以改善膳食油的抗氧化状态，也可以改善氧化应激标志物。另一方面，叔丁基对苯二酚（TBHQ）是一种已批准的食品级合成抗氧化剂，它既是致癌作用的诱导剂，也是抑制剂。本试验将探讨阿月浑子种子-菜籽油、含 TBHQ 的玉米-菜籽油和不含 TBHQ 的玉米-菜籽油混合物对 MetS 患者氧化应激标志物的可能影响。
我们将在 72 名 MetS 患者中进行一项单中心、三盲、三向随机交叉临床试验（RCT）。在 1 个月的洗脱期后，合格的参与者将以随机顺序将干预油作为他们经常食用的油。每个干预期持续 8 周，间隔 4 周洗脱期。在每个干预期的开始和结束时，将评估人体测量指数、身体成分、体力活动、血压和 24 小时膳食食物回忆测量。主要结局指标为氧化应激标志物，包括血清总抗氧化能力、总氧化状态、丙二醛、一氧化氮以及髓过氧化物酶、超氧化物歧化酶、过氧化氢酶、谷胱甘肽过氧化物酶和谷胱甘肽还原酶的酶活性。次要结局指标为 MetS 成分的变化，包括血压、空腹血糖、甘油三酯、高密度脂蛋白胆固醇和人体测量指标。
阿月浑子籽油富含抗氧化剂。这种油的干预可能为代谢综合征患者的氧化应激预防提供一种选择。本临床研究将是第一个评估阿月浑子油对人体氧化应激标志物影响的研究。
伊朗临床试验注册处 IRCT20130223012571N8。于 2022 年 3 月 4 日注册。
