Age-related Cognitive Changes: Effects of Combined Flavonoid Intake and Physical Exertion Mediated by the Gut Microbiome
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 240
- 试验地点
- 2
- 主要终点
- Cognition
研究概览
简要总结
This NIH project will examine the effects of routine flavonoid-rich blueberry intake (12-weeks), combined with or in the absence of regular moderate exercise, on cognitive function in a clinical population of older participants identified as experiencing age-related cognitive changes. This project's hypothesis is that the combination of flavonoid-rich diet and routine physical activity may potentiate cognitive benefits and reduce cognitive decline in an aging population, via mechanisms mediated by the gut microbiome.
详细描述
This randomized clinical trial (RCT) is designed to investigate the effect of 12-weeks blueberry ingestion (50 g freeze dried powder per day, equivalent to 2 cups fresh blueberries per day) with or without brisk walking (five 45-minute supervised sessions per week) on cognitive function in healthy older adult participants. An important aim is to determine if this potential benefit is mediated through changes in the gut microbiome profile and an increase in gut-derived phenolics.
Older adult participants (n=240, with a goal of 200 completing all procedures) will be randomized to one of four groups: blueberry-walking, blueberry-stretching, placebo-walking, and placebo-stretching. The blueberry and placebo powder supplements will be ingested using double blind procedures. Blood, urine, and stool samples will be collected pre-study, and then again after 6- and 12-weeks. Cognitive function and cardiorespiratory fitness will be measured at the same time points. Participants will be assessed for processing speed, episodic memory, working memory, and sustained attention using the Cambridge Neuropsychological Test Assessment Battery (CANTAB, Cambridge Cognition, Ltd) (laboratory of Dr. Carol Cheatham, UNC Chapel Hill). Urine samples will be analyzed for gut-derived phenolic metabolites via liquid chromatography tandem MS/MS (lab of Dr. Mary Ann Lila, NCSU). Taxonomic and functional profiles from metagenomic sequencing of the stool samples will be acquired (UNC Chapel Hill).
Recruitment. Healthy older adult participants (240 to start, 200 to finish) will be recruited from the Charlotte, NC, metropolitan area. Healthy, nonsmoking, physically inactive male and female participants (targeting 65-85 years of age, BMI less than 35) with cognitive changes will be selected who match the inclusion and exclusion criteria.
Design. This study will employ a randomized, double blind, placebo controlled, parallel group research design, with participants (60) assigned to one of 4 arms for the 12 week trial period: blueberry and walking; blueberry and stretching; placebo and walking; placebo and stretching.
Schedule
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
盲法说明
Investigators and study participants will be blind to treatment allocation, with the blueberry and placebo supplements administered in identical packets.
入排标准
- 年龄范围
- 65 Years 至 85 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Score on the Montreal Cognitive Assessment (MoCA test) of 24.1-25.2 that indicates mild cognitive decline.
- •Healthy, non-smoking male or female participants 65 to 85 years of age.
- •Capable of engaging in a supervised 12-week exercise training program (brisk walking or stretching).
- •Physically inactive (defined as less than 150 min/week moderate or less than 75 minutes vigorous aerobic and/or resistance exercise during the past 4 weeks).
- •Willingness to be randomized to one of four groups.
- •Willingness to provide blood, urine, and fecal samples (3 each),
- •Willingness to avoid blueberry intake during the 12-weeks study (other than what is provided through the study).
- •Willingness to maintain current diet and physical activity patterns during the study (other than what is prescribed as a part of the study), and make no formal attempts to lose or gain body weight.
- •Willingness to be a participant in this study only and not enter any other studies.
排除标准
- •Allergy to blueberries.
- •Diagnosis of Type I or Type 2 diabetes.
- •Chronic cardiovascular, metabolic, or renal condition that is uncontrolled (controlled defined as stable for 6 months or more).
- •History of signs or symptoms during rest or physical activity such as chest discomfort, unreasonable breathlessness, dizziness, fainting, or blackouts.
- •Use of any prescription or over-the-counter drug intended to support cognition or with known cognitive side effects.
- •Any other concurrent condition or use of medications or supplements which, in the opinion of the study clinician would preclude participation in this study.
- •Diagnosis of dementia.
结局指标
主要结局
Cognition
时间窗: Change from pre-study to 6-weeks and 12-weeks
Cognitive function using the Cambridge Neuropsychological Test Assessment Battery (CANTAB, Cambridge Cognition, Ltd).
次要结局
- Maximal aerobic capacity(Change from pre-study to 6-weeks and 12-weeks)
- Gut microbiome(Change from pre-study to 6-weeks and 12-weeks)
- Urine blueberry metabolites(Change from pre-study to 6-weeks and 12-weeks)
- Electrophysiological procedures (ERP) using the Geodesic Sensor Net(Change from pre-study to 6-weeks and 12-weeks)