富含多酚的葡萄干膳食补充剂对健康老年人认知功能的影响：一项随机临床试验研究方案。

Effect of including a dietary supplement of raisins, a food rich in polyphenols, on cognitive function in healthy older adults; a study protocol for a randomized clinical trial.

机构信息

Grupo de Investigación de Polifenoles, Universidad de Salamanca, 37007, Salamanca, Spain.

Facultad de Enfermería Y Fisioterapia, Universidad de Salamanca, 37007, Salamanca, Spain.

出版信息

BMC Geriatr. 2023 Mar 29;23(1):182. doi: 10.1186/s12877-023-03882-6.

DOI:10.1186/s12877-023-03882-6

PMID:36991396

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10052855/

Abstract

BACKGROUND

Polyphenols have been shown to be effective against many chronic diseases, including neurodegenerative diseases. Specifically, the consumption of raisins, being a food rich in polyphenols, has been attributed with neuroprotective benefits. Therefore, our main objective is to evaluate the effect of including 50 g of raisins in the diet daily for 6 months, on the improvement of cognitive performance, cardiovascular risk factors and markers of inflammation in a population of older adults without cognitive impairment.

METHODS

Design and intervention: This study will be a randomized controlled clinical trial of two parallel groups. Each subject included in the study will be randomly assigned to one of two study groups: control group (no supplement), intervention group (50 g of raisins daily during 6 months).

STUDY POPULATION

The participants will be selected by consecutive sampling in the Primary Care consultations of urban health centers in Salamanca and Zamora (Spain), taking into account the selection criteria.

STUDY VARIABLES

Two visits will be made, baseline and at 6 months. Cognitive performance will be evaluated (Mini-Mental State Examination test, Rey Auditory Verbal Learning Test, verbal fluency and montreal cognitive assessment (Moca)). It will also be analyzed the level of physical activity, quality of life, activities of daily living, energy and nutritional composition of the diet, body composition, blood pressure, heart rate, markers of inflammation and other laboratory tests of clinical relevance (glycaemia, total cholesterol, HDL cholesterol, LDL cholesterol and triglycerides). In addition, sociodemographic data, personal and family history, medication use and alcohol and tobacco consumption will be collected.

DISCUSSION

In this project, it is intended to contribute to minimize the problems derived from cognitive deterioration in older people.

TRIAL REGISTRATION

ClincalTrials.gov Identifier: NCT04966455 Registration date: July 1, 2021.

摘要

背景

多酚已被证明对许多慢性疾病有效，包括神经退行性疾病。具体来说，食用葡萄干，作为一种富含多酚的食物，被认为具有神经保护作用。因此，我们的主要目标是评估每天在饮食中加入 50 克葡萄干，持续 6 个月，对改善认知表现、心血管风险因素和炎症标志物的影响在没有认知障碍的老年人群中。

方法

设计和干预：这是一项为期 6 个月的、包含 2 个平行组的随机对照临床试验。纳入研究的每个受试者将被随机分配到两个研究组之一：对照组（无补充剂），干预组（每天 50 克葡萄干，持续 6 个月）。

研究人群

将通过连续抽样在萨拉曼卡和萨莫拉（西班牙）的城市卫生中心的初级保健咨询中选择参与者，同时考虑到选择标准。

研究变量

将进行两次访视，基线和 6 个月时。将评估认知表现（简易精神状态检查测试、 Rey 听觉言语学习测试、言语流畅性和蒙特利尔认知评估（MoCA））。还将分析身体活动水平、生活质量、日常生活活动、饮食的能量和营养成分、身体成分、血压、心率、炎症标志物和其他临床相关实验室测试（血糖、总胆固醇、高密度脂蛋白胆固醇、低密度脂蛋白胆固醇和甘油三酯）。此外，将收集社会人口统计学数据、个人和家族史、用药情况以及酒精和烟草消费情况。