School of Medical, Indigenous and Health Sciences, Faculty of Science, Medicine and Health, University of Wollongong, Wollongong, New South Wales, Australia.
Centre for Healthy Brain Ageing, School of Clinical Medicine, Faculty of Medicine and Health, University of New South Wales, Sydney, New South Wales, Australia.
BMJ Open. 2024 Sep 10;14(9):e086435. doi: 10.1136/bmjopen-2024-086435.
Promising evidence is emerging for the procognitive, anti-inflammatory and neuroprotective properties of dietary flavonoids, particularly anthocyanins that provide red, purple and blue plant pigments.
The 'Food for Thought' study is a multicentre, 6-month randomised, parallel 3-arm clinical trial. Its primary aim is to investigate whether anthocyanin consumption, either through diet or supplementation, can prevent memory loss progression and improve inflammatory and cardiovascular health in older adults at risk for dementia. Eligible participants will include those aged 60-85 years with a diagnosis of amnestic mild cognitive impairment or with a self-referral of memory concerns and scoring ≤13 on the Memory Index Score within the Telephone Montreal Cognitive Assessment screening test. Participants will be randomised to one of three arms: High anthocyanin ('purple foods') diet (aiming for a target of 250 mg anthocyanins/day); freeze-dried product derived from blackcurrants (250 mg anthocyanins/day); or control (coloured maltose powder). The primary outcome is auditory anterograde memory functioning assessed by the Buschke and Grober Free and Cued Selective Reminding Test-Immediate Recall. Secondary outcomes are additional cognitive functions including processing speed, working memory, aspects of executive functioning (attentional shifting and word generativity) and premorbid estimate as well as subjective memory problems and self-reported depression symptoms. Additional secondary outcomes are blood pressure, inflammatory biomarkers, brain-derived neurotrophic factor, fatty acid profile, apolipoprotein E and polyphenol metabolites, gut microbiota composition and function and vascular and microvascular endothelial function tests. Repeated measures analysis of variance and/or mixed linear modelling will evaluate changes over time, with the inclusion of covariates.
Ethics approval has been obtained from the Greater Western Human Research Ethics Committee (2021/ETH12083). A Consumer Advisory Group was established to guide and review the protocol and dissemination strategy. The results of this trial are intended to be published in a peer-reviewed journal.
National Health and Medical Research Centre Dementia Collaborative Research Centre.Start date of clinical trial: 02 September 2022.Expected end date: 11 October 2024.
ACTRN12622000065796.
越来越多的证据表明，饮食中的类黄酮，尤其是提供红色、紫色和蓝色植物色素的花色苷，具有促进认知、抗炎和神经保护作用。
“思考食物”研究是一项多中心、6 个月的随机、平行 3 臂临床试验。其主要目的是研究通过饮食或补充剂摄入花色苷是否可以预防记忆丧失的进展，并改善痴呆风险的老年人的炎症和心血管健康。合格的参与者将包括年龄在 60-85 岁之间的人，他们被诊断为遗忘型轻度认知障碍，或通过电话蒙特利尔认知评估筛查测试中的记忆指数评分≤13 分自我报告有记忆问题。参与者将被随机分配到以下三个组之一：高花色苷（“紫色食物”）饮食（目标为每天 250mg 花色苷）；黑加仑冻干产品（每天 250mg 花色苷）；或对照组（有色麦芽糖粉）。主要结局是通过 Buschke 和 Grober 自由和线索选择性提醒测试-即时回忆评估听觉顺行记忆功能。次要结局是包括处理速度、工作记忆、执行功能（注意力转换和词语生成）和前摄估计在内的其他认知功能，以及主观记忆问题和自我报告的抑郁症状。其他次要结局是血压、炎症生物标志物、脑源性神经营养因子、脂肪酸谱、载脂蛋白 E 和多酚代谢物、肠道微生物群组成和功能以及血管和微血管内皮功能测试。重复测量方差分析和/或混合线性模型将评估随时间的变化，并包括协变量。
大西部人类研究伦理委员会已批准该研究（2021/ETH12083）。成立了消费者咨询小组，以指导和审查方案和传播策略。该试验的结果旨在发表在同行评议的期刊上。
国家卫生与医学研究中心痴呆症合作研究中心。临床试验开始日期：2022 年 9 月 2 日。预计结束日期：2024 年 10 月 11 日。
ACTRN12622000065796。
