Yari Zahra, Naser-Nakhaee Zahra, Karimi-Shahrbabak Elahe, Cheraghpour Makan, Hedayati Mehdi, Mohaghegh Seyede Marjan, Ommi Shahrzad, Hekmatdoost Azita
Department of Clinical Nutrition and Dietetics, Faculty of Nutrition and Food Technology, National Nutrition and Food Technology, Research Institute Shahid Beheshti University of Medical Sciences, Tehran, Iran.
Human Nutrition Department, McGill University, Montreal, QC, Canada.
Diabetol Metab Syndr. 2021 Jan 6;13(1):3. doi: 10.1186/s13098-020-00619-y.
Regarding the increasing prevalence of cardiometabolic abnormalities, and its association with non-communicable chronic diseases, providing preventive and therapeutic strategies is a priority. A randomized placebo-controlled study was conducted to assess the effects of combination therapy of milled brown flaxseed and hesperidin during lifestyle intervention on controlling cardiovascular risk in prediabetes.
A total of forty-eight subjects were randomly assigned to receive lifestyle intervention plus combination therapy of brown flaxseed (30 g milled) and hesperidin (two 500 mg capsules) or lifestyle modification alone for 12 weeks. Changes from baseline in anthropometric measures, lipid profile and atherogenic indices, glucose homeostasis parameters, and inflammatory biomarkers was assessed as a primary end point.
Anthropometric data comparison between the two groups showed a significant reduction in weight (p = 0.048). Waist circumference reduction was about twice that of the control group (- 6.75 cm vs - 3.57 cm), but this difference was not statistically significant. Comparison of blood pressure changes throughout the study indicated a greater reduction in blood pressure in the intervention group rather than control group (- 5.66 vs. - 1.56 mmHg, P = 0.049). Improvements of lipid profile and atherogenic indices, glucose homeostasis parameters, and inflammatory biomarkers in flaxseed-hesperidin group was significantly more than the control group after 12 weeks of intervention (p < 0.05).
Our results indicate that co-administration of flaxseed and hesperidin as an adjunct to lifestyle modification program is more effective than lifestyle modification alone in the metabolic abnormalities remission of prediabetic patients.
The trial was registered with ClinicalTrials.gov, number NCT03737422. Registered 11 November 2018. Retrospectively registered, https://clinicaltrials.gov/ct2/results?cond=&term=NCT03737422&cntry=&state=&city=&dist= .
鉴于心脏代谢异常的患病率不断上升及其与非传染性慢性病的关联，提供预防和治疗策略是当务之急。开展了一项随机安慰剂对照研究，以评估在生活方式干预期间，碾碎的棕色亚麻籽和橙皮苷联合治疗对控制糖尿病前期心血管风险的效果。
总共48名受试者被随机分配接受生活方式干预加棕色亚麻籽（30克碾碎的）和橙皮苷（两粒500毫克胶囊）联合治疗，或仅接受生活方式改变，为期12周。将人体测量指标、血脂谱和致动脉粥样硬化指数、葡萄糖稳态参数以及炎症生物标志物相对于基线的变化作为主要终点进行评估。
两组之间的人体测量数据比较显示体重显著降低（p = 0.048）。腰围减少量约为对照组的两倍（-6.75厘米对-3.57厘米），但这一差异无统计学意义。对整个研究过程中血压变化的比较表明，干预组的血压下降幅度大于对照组（-5.66对-1.56毫米汞柱，P = 0.049）。干预12周后，亚麻籽-橙皮苷组的血脂谱和致动脉粥样硬化指数、葡萄糖稳态参数以及炎症生物标志物的改善情况明显优于对照组（p < 0.05）。
我们的结果表明，在糖尿病前期患者的代谢异常缓解方面，将亚麻籽和橙皮苷联合使用作为生活方式改变计划的辅助手段比单纯的生活方式改变更有效。
该试验已在ClinicalTrials.gov注册，编号NCT03737422。于2018年11月11日注册。回顾性注册，https://clinicaltrials.gov/ct2/results?cond=&term=NCT03737422&cntry=&state=&city=&dist= 。
