Murray Margaret, Dordevic Aimee L, Cox Katherine H M, Scholey Andrew, Ryan Lisa, Bonham Maxine P
Department of Nutrition, Dietetics and Food, Monash University, Notting Hill, Victoria, Australia.
Centre for Human Psychopharmacology, Swinburne University of Technology, Hawthorn, Victoria, Australia.
BMJ Open. 2018 Dec 14;8(12):e022195. doi: 10.1136/bmjopen-2018-022195.
Hyperlipidaemia, hyperglycaemia and chronic inflammation are risk factors for chronic diseases cardiovascular disease and type 2 diabetes. Polyphenols are bioactive compounds found in marine algae with potential antihyperlipidaemic, antihyperglycaemic and anti-inflammatory effects. The modulation of these risk factors using bioactive polyphenols may represent a useful strategy for disease prevention and management; research in humans, however, remains limited. This trial aims to determine the impact of a polyphenol-rich brown seaweed extract on fasting hyperlipidaemia, hyperglycaemia and inflammation. Effects on mood and cognition will also be evaluated.
Fifty-eight hypercholesterolaemic participants who are overweight or have obesity will be randomised to receive either a polyphenol-rich brown seaweed extract (2000 mg dose containing 600 mg polyphenols) or placebo (2000 mg rice flour) daily for 12 weeks. Fasting venous blood samples will be taken at baseline, week 6 and week 12 of the intervention to assess serum cholesterol (total, low-density lipoprotein and high-density lipoprotein) and triglyceride concentrations, plasma glucose and insulin concentrations and markers of inflammation. Mood and cognitive function will be evaluated as exploratory outcomes. Independent t-tests or equivalent will be used to determine differences between the two groups in changes from baseline to week 12. Analysis of variance will be used to assess differences between the groups across the three time points (baseline, week 6 and week 12).
Ethics approval has been granted by the Monash University Human Research Ethics Committee (2017-8689-10379). Results from this trial will be disseminated through publication in peer-reviewed journals, national and international presentations, and a PhD thesis. These results are essential to inform the use of polyphenol-rich brown seaweeds as a functional food or nutritional supplement ingredients for health promotion and disease prevention and management in humans.
ACTRN12617001039370; Pre-results.
高脂血症、高血糖症和慢性炎症是心血管疾病和2型糖尿病等慢性疾病的危险因素。多酚是在海藻中发现的生物活性化合物，具有潜在的降血脂、降血糖和抗炎作用。使用生物活性多酚调节这些危险因素可能是疾病预防和管理的有用策略；然而，人体研究仍然有限。本试验旨在确定富含多酚的褐藻提取物对空腹高脂血症、高血糖症和炎症的影响。还将评估对情绪和认知的影响。
58名超重或肥胖的高胆固醇血症参与者将被随机分组，每天接受富含多酚的褐藻提取物（2000毫克剂量，含600毫克多酚）或安慰剂（2000毫克米粉），持续12周。在干预的基线、第6周和第12周采集空腹静脉血样，以评估血清胆固醇（总胆固醇、低密度脂蛋白和高密度脂蛋白）和甘油三酯浓度、血浆葡萄糖和胰岛素浓度以及炎症标志物。情绪和认知功能将作为探索性结果进行评估。将使用独立t检验或等效方法来确定两组从基线到第12周变化的差异。方差分析将用于评估三个时间点（基线、第6周和第12周）各组之间的差异。
莫纳什大学人类研究伦理委员会已批准伦理许可（2017 - 8689 - 10379）。本试验结果将通过在同行评审期刊上发表、在国内和国际会议上报告以及一篇博士论文进行传播。这些结果对于将富含多酚的褐藻作为功能性食品或营养补充剂成分用于促进人类健康以及疾病预防和管理至关重要。
ACTRN12617001039370；预结果。
