Effects of PROtein enriched MEDiterranean Diet and EXercise on nutritional status and cognition in adults at risk of undernutrition and cognitive decline: the PROMED-EX Randomised Controlled Trial.
Effects of PROtein enriched MEDiterranean Diet and EXercise on nutritional status and cognition in adults at risk of undernutrition and cognitive decline: the PROMED-EX Randomised Controlled Trial.
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富含蛋白质的地中海饮食与运动对存在营养不良及认知能力下降风险的成年人营养状况和认知功能的影响：PROMED - EX随机对照试验
DOI：
10.1136/bmjopen-2022-070689
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发表时间：
2023-10-25
期刊：
影响因子：
2.9
通讯作者：
中科院分区：
文献类型：
--
作者：
营养不良导致计划外减肥在老年人中很常见，并与晚年痴呆症风险增加有关。体重减轻可以在痴呆症之前十年或更长时间，为早期干预提供了一个独特的机会，以纠正营养不良，并可能预防或延迟认知障碍。饮食和运动对营养不良的综合影响尚未得到评估。这项试验的目的是确定富含蛋白质的地中海饮食，有和没有运动，对营养不良和认知能力下降的老年人的营养状况和认知能力的影响。将招募105名年龄在60岁及以上、有营养不良风险和主观认知下降的受试者参加一项为期6个月的单盲、平行组随机对照试验。参与者将被随机分为三组：第1组-PROMED-EX（饮食+运动），第2组-PROMED（仅饮食）和第3组-标准护理（对照）。主要结果是使用迷你营养评估测量的营养状况。次要结果包括认知功能、营养摄入、身体成分、身体功能和生活质量。将通过测量炎症、代谢、营养和代谢组学生物标志物来探索潜在饮食和运动诱导的营养状态和认知变化的机制途径。本研究由英国研究伦理委员会办公室批准（参考号：21/NW/0215）。招募前将获得受试者的书面知情同意书。研究结果将通过会议和媒体向公众传播，并通过会议介绍和在学术期刊上发表向科学界传播。ClinicalTrials.gov注册表（NCT 05166564）。
Undernutrition leading to unplanned weight loss is common in older age and has been linked to increased dementia risk in later life. Weight loss can precede dementia by a decade or more, providing a unique opportunity for early intervention to correct undernutrition and potentially prevent or delay cognitive impairment. The combined effects of diet and exercise on undernutrition have not yet been evaluated. The objective of this trial is to determine the effect of a protein-enriched Mediterranean diet, with and without exercise, on nutritional status and cognitive performance in older adults at risk of undernutrition and cognitive decline. One hundred and five participants aged 60 years and over at risk of undernutrition and with subjective cognitive decline will be recruited to participate in a 6-month, single-blind, parallel-group randomised controlled trial. Participants will be block randomised into one of three groups: group 1—PROMED-EX (diet+exercise), group 2—PROMED (diet only) and group 3—standard care (control). The primary outcome is nutritional status measured using the Mini Nutritional Assessment. Secondary outcomes include cognitive function, nutritional intake, body composition, physical function and quality of life. Mechanistic pathways for potential diet and exercise-induced change in nutritional status and cognition will be explored by measuring inflammatory, metabolic, nutritional and metabolomic biomarkers. The study is approved by the UK Office for Research Ethics Committee (ref: 21/NW/0215). Written informed consent will be obtained from participants prior to recruitment. Research results will be disseminated to the public via meetings and media and the scientific community through conference presentations and publication in academic journals. ClinicalTrials.gov Registry (NCT05166564).
影响因子：
3.3
作者：
O'Neill, Roisin F.;Brennan, Lorraine;Prinelli, Federica;Sergi, Giuseppe;Trevisan, Caterina;De Groot, Lisette C. P. G. M.;Volkert, Dorothee;Maggi, Stefania;Noale, Marianna;Conti, Silvia;Adorni, Fulvio;Woodside, Jayne V.;McKinley, Michelle C.;McGuinness, Bernadette;Cardwell, Chris;McEvoy, Claire T.
通讯作者：
McEvoy, Claire T.