Department of Surgery, Texas Tech University Health Sciences Center, Lubbock, Texas, USA.
Kinesiology and Sport Management, Texas Tech University, Lubbock, Texas, USA.
BMJ Open. 2020 Mar 8;10(3):e034338. doi: 10.1136/bmjopen-2019-034338.
Obesity is a major health concern in postmenopausal women, and chronic low-grade inflammation contributes to the development of obesity. Cellular studies and high-fat-diet-induced obese mouse model mimicking obesity show the antiobesity effect of annatto-extracted tocotrienols (TT) with antioxidant capability. We aim to assess the safety and efficacy of TT consumption for lipid-related parameters in obese postmenopausal women.
Eligible obese postmenopausal women will be randomly assigned to placebo group (430 mg olive oil) and TT group (DeltaGold Tocotrienol 70%) for 24 weeks. In the present study, the primary outcome is total/regional fat mass and visceral adipose tissue. The secondary outcomes include lipid profile in serum, mRNA expression of fatty acid synthase and carnitine palmitoyltransferase 1A in fat tissue, oxylipins and endocannabinoids in plasma and adipose tissue, abundance and composition of intestinal microbiome in faeces, high-sensitivity C-reactive protein (hs-CRP) in serum and leptin in serum. Every participant will be evaluated at 0 (prior to starting intervention) and 24 weeks of intervention, except for serum lipid profile and hs-CRP at 0, 12 and 24 weeks. '' principle is employed for data analysis. Hierarchical linear modelling is used to estimate the effects of dietary TT supplementation while properly accounting for dependency of data and identified covariates. To our knowledge, this is the first randomised, placebo-controlled, double-blinded study to determine dietary TT supplementation on an obese population. If successful, this study will guide the future efficacy TT interventions and TT can be implemented as an alternative for obese population in antiobesity management.
This study has been approved by the Bioethics Committee of the Texas Tech University Health Sciences Center, Lubbock. An informed consent form will be signed by a participant before enrolling in the study. The results from this trial will be actively disseminated through academic conference presentation and peer-reviewed journals.
NCT03705845.
肥胖是绝经后妇女的主要健康问题，慢性低度炎症是肥胖发展的原因之一。细胞研究和高脂肪饮食诱导的肥胖小鼠模型模拟肥胖表明，具有抗氧化能力的胭脂树提取物生育三烯酚（TT）具有抗肥胖作用。我们旨在评估 TT 消耗对肥胖绝经后妇女脂质相关参数的安全性和有效性。
符合条件的肥胖绝经后妇女将被随机分配到安慰剂组（430mg 橄榄油）和 TT 组（DeltaGold 生育三烯酚 70%），干预时间为 24 周。在本研究中，主要结局是总/局部脂肪量和内脏脂肪组织。次要结局包括血清中的脂质谱、脂肪组织中脂肪酸合酶和肉毒碱棕榈酰转移酶 1A 的 mRNA 表达、血浆和脂肪组织中的氧化脂质和内源性大麻素、粪便中肠道微生物组的丰度和组成、血清中的高敏 C 反应蛋白（hs-CRP）和血清中的瘦素。除了血清脂质谱和 hs-CRP 在 0、12 和 24 周外，每个参与者将在 0（开始干预前）和 24 周时进行评估。“意向性分析”原则用于数据分析。分层线性建模用于估计饮食 TT 补充的效果，同时适当考虑数据的依赖性和已确定的协变量。据我们所知，这是第一项随机、安慰剂对照、双盲研究，旨在确定肥胖人群中饮食 TT 补充的效果。如果成功，这项研究将指导未来 TT 干预的疗效，TT 可以作为肥胖人群肥胖管理的替代方法。
本研究已获得德克萨斯理工大学健康科学中心生物伦理委员会的批准。参与者在入组前将签署知情同意书。试验结果将通过学术会议报告和同行评议期刊积极传播。
NCT03705845。
