Nutrition effects on brain outcomes and recovery in stroke after hospitalization (NOURISH): Randomized controlled trial protocol and rationale

IF 1.9 3区医学 Q3 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary clinical trials Pub Date : 2025-10-10 DOI:10.1016/j.cct.2025.108108

Laurel Cherian , Puja Agarwal , Klodian Dhana , Vincent Carey , Mark A. Espeland , Nancy Laranjo , Xavier Reilly , Cheng Hong , Pyone Maung , Chiquia Hollings , Beth Lukaszewicz , Jennifer Ventrelle , Jameszetta James , Amy Tran , Santosh Basapur , Thomas Holland , Kristin R. Krueger , Xiaoran Liu , Dixon Yang , James R. Brorson , Neelum T. Aggarwal

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引用次数: 0

Abstract

Background

Risk of dementia doubles after stroke. There is limited information on reduction of risk, but diet is a significant modifiable risk factor for both vascular health and cognition.

Objective

Nutrition effects on brain Outcomes and Recovery In Stroke after Hospitalization (NOURISH; registration no. NCT04337255) is a phase III randomized controlled trial designed to test the effects of the MIND diet on changes in cognition following an acute ischemic stroke.

Study methods

Eligible participants aged 55 and older were randomized to either the MIND diet intervention facilitated by credentialled nutritionists plus post-stroke care (Coach) or a post-stroke care intervention led by health educators (Self) for 24–36 months. Repeated assessments included anthropometric measurements, cognitive testing, blood and urinary biomarkers, and a variety of validated post-stroke outcome measures and follow-up visits for up to 3 years, with MRI scans conducted on a subset of participants at baseline and the study's end.

Unique features of this study include:

•
Lifestyle and diet counseling to support the adoption of the MIND diet post-stroke in the Coach group
•
Post-stroke counseling which includes counseling for reduced sodium and saturated fat consumption by both groups
•
90 days of delivered meals
•
Detailed cognitive assessments, tracking longitudinal changes in cognitive function post-stroke
•
MRI scans to assess brain structure, potentially providing evidence of diet-related effects on the brain

Conclusions

This study will evaluate the MIND diet intervention in preventing cognitive impairment in older adults after acute stroke. Findings will provide insights for the development of dietary guidelines for post-stroke care.

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营养对脑卒中住院后脑预后和恢复的影响（营养）：随机对照试验方案和基本原理

中风后患痴呆的风险增加一倍。关于降低风险的信息有限，但饮食对血管健康和认知都是一个重要的可改变的风险因素。目的探讨营养对脑卒中住院后脑预后及康复的影响。nct0437255)是一项III期随机对照试验，旨在测试MIND饮食对急性缺血性卒中后认知变化的影响。研究方法符合条件的55岁及以上的参与者被随机分配到由有资格的营养学家指导的MIND饮食干预加上中风后护理（Coach）或由健康教育者领导的中风后护理干预（Self）中，为期24-36个月。重复评估包括人体测量、认知测试、血液和尿液生物标志物，以及各种经过验证的中风后结果测量和长达3年的随访，在基线和研究结束时对一部分参与者进行MRI扫描。这项研究的独特之处包括：•生活方式和饮食咨询，以支持教练组中风后采用MIND饮食•中风后咨询，包括两组减少钠和饱和脂肪消耗的咨询•90天的送餐•详细的认知评估，跟踪中风后认知功能的纵向变化•MRI扫描评估大脑结构，结论本研究将评估MIND饮食干预在预防老年人急性脑卒中后认知功能障碍中的作用。研究结果将为卒中后护理饮食指南的制定提供见解。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Contemporary clinical trials 医学-药学

CiteScore

3.70

自引率

4.50%

发文量

281

审稿时长

44 days

期刊介绍： Contemporary Clinical Trials is an international peer reviewed journal that publishes manuscripts pertaining to all aspects of clinical trials, including, but not limited to, design, conduct, analysis, regulation and ethics. Manuscripts submitted should appeal to a readership drawn from disciplines including medicine, biostatistics, epidemiology, computer science, management science, behavioural science, pharmaceutical science, and bioethics. Full-length papers and short communications not exceeding 1,500 words, as well as systemic reviews of clinical trials and methodologies will be published. Perspectives/commentaries on current issues and the impact of clinical trials on the practice of medicine and health policy are also welcome.