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Abstract：
BACKGROUND: 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.
METHODS: 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.
CONCLUSIONS: 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.
BACKGROUND: Iranian Registry of Clinical trials IRCT20130223012571N8 . Registered on 4 March 2022.
METHODS: 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.
CONCLUSIONS: 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.
BACKGROUND: Iranian Registry of Clinical trials IRCT20130223012571N8 . Registered on 4 March 2022.
摘要：
背景：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已成为焦点.黄连木油被认为是一种高抗氧化油，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,叔丁基氢醌（TBHQ）是一种批准的食品级合成抗氧化剂，可作为致癌作用的诱导剂和抑制剂。当前的试验将探索黄连木种子菜籽油混合物的可能效果，玉米菜籽油与TBHQ，和不含TBHQ的玉米-菜籽油对MetS患者氧化应激标志物的影响。
方法：我们将进行单中心，三盲，72例MetS患者的三向随机交叉临床试验（RCT）。经过1个月的磨合期，符合条件的参与者将以随机顺序消耗干预油作为其定期消耗的油。每个干预期将持续8周，分为4周的清除期。人体测量指数,身体成分,身体活动,血压,24小时饮食食品召回测量将在每个干预期的开始和结束时进行评估。主要结果将是氧化应激标志物，包括血清总抗氧化能力，总氧化剂状态，丙二醛，一氧化氮,和髓过氧化物酶的酶活性，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.次要结果将是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。
结论：黄连木种子油富含抗氧化剂。用这种油进行干预可以为代谢综合征患者提供预防氧化应激的选择。本临床试验将是第一个评估黄连木油对人类氧化应激标志物影响的临床试验。
背景：伊朗临床试验IRCT20130223012571N8注册。2022年3月4日注册。
方法：我们将进行单中心，三盲，72例MetS患者的三向随机交叉临床试验（RCT）。经过1个月的磨合期，符合条件的参与者将以随机顺序消耗干预油作为其定期消耗的油。每个干预期将持续8周，分为4周的清除期。人体测量指数,身体成分,身体活动,血压,24小时饮食食品召回测量将在每个干预期的开始和结束时进行评估。主要结果将是氧化应激标志物，包括血清总抗氧化能力，总氧化剂状态，丙二醛，一氧化氮,和髓过氧化物酶的酶活性，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.次要结果将是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。
结论：黄连木种子油富含抗氧化剂。用这种油进行干预可以为代谢综合征患者提供预防氧化应激的选择。本临床试验将是第一个评估黄连木油对人类氧化应激标志物影响的临床试验。
背景：伊朗临床试验IRCT20130223012571N8注册。2022年3月4日注册。
