Vitamin K Supplementation to Improve Cognition of Patients With Coronary Heart Disease: a Randomized Controlled Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Change in general cognitive functioning
研究概览
简要总结
The purpose of this pilot study is to obtain a preliminary assessment of the effect of VK supplementation on cognitive performance and vascular function in adults with stable Coronary Heart Disease (CHD)
详细描述
The overall goal of this study is to obtain a preliminary assessment of the effect of a VK1 (phylloquinone) supplementation on cognitive performance (primary outcome) and vascular function (secondary outcome) in adults with stable CHD. Specifically, the investigators will conduct a double-blind, 2-armed, parallel-group intervention study in which 40 men and women aged 60 years and over with stable CHD will be randomly assigned to 0.5 mg phylloquinone per day or matching placebo for a period of 3 months. All participants will have signed a written consent form before taking part in the study
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women
- •Age 60 years and older
- •Medically documented stable Coronary Heart Disease (CHD)
- •Daily dietary intakes of phylloquinone <150 mcg
- •Non-consumption of vitamin K supplements (i.e. K1 or K2, singly or in combination with other nutrients), or other cognitive aids
- •Good French or English understanding
- •Physical exercise not exceeding 2.5 hours/week of moderate to vigorous aerobic activity
- •Capacity and willingness to sign informed consent
排除标准
- •Recent acute coronary syndrome (<3 months) or recent coronary revascularization (bypass surgery or percutaneous coronary intervention, <3 months)
- •Known left ventricular dysfunction (LVEF < 40%) or chronic heart failure
- •Recent modification of medication (<2 weeks)
- •Warfarin (Coumadin) use
- •Cognitive impairment (based on telephone version of the Mini-Mental State Examination test, score <19/23)
- •Diagnosis of depression or uncontrolled anxiety
- •Malabsorption disorder (advanced liver disease, Crohn's disease)
- •Patient with auditory or vision impairments not properly corrected by glasses or hearing aids
- •Unable to read the informed consent form or unable to understand the oral explanations provided by the assessor
结局指标
主要结局
Change in general cognitive functioning
时间窗: Baseline and post-intervention at 12 weeks
Montreal Cognitive Assessment (0-30 score, with a higher score indicating a better cognitive functioning)
Change in processing speed
时间窗: Baseline and post-intervention at 12 weeks
Processing speed is assessed using the Coding subtest from the Wechsler Adult Intelligence Scale (WAIS)IV. The participant is asked to reproduce, as rapidly as possible, a series of symbols associated with digits in a 2-min time period
Change in executive functions
时间窗: Baseline and post-intervention at 12 weeks
Executive function is assessed using 1. Delis-Kaplan Executive Function System (D-KEFS) subtests \[Trail Making Test; Phonological and Semantic Fluency test \[Letters P, T, L (60s maximum); Categories: animals, men's names (60s maximum)\] 2. WAISIV subtests ("Switching" between naming fruit and furniture (60s maximum)\] 3. Neuropeak platform developed by Dr Bherer's laboratory: dual-task (divided attention) and n-back (working memory and updating). These tasks are tablet/computer-based As these tests use different scales, z-scores will be calculated for the different tests and a composite z-score will be generated for the domain
Change in episodic memory
时间窗: Baseline and post-intervention at 12 weeks
Episodic memory is assessed using: 1. Rey auditory verbal learning test (RAVLT). Score 0-75, with a higher score indicating a better memory 2. Digit span, a test that requires participants to repeat series of digits of increasing length As these tests use different scales, z-scores will be calculated for the different tests and a composite z-score will be generated for the domain
次要结局
- Change in cerebral autoregulation - middle cerebral arteries(Baseline and post-intervention at 12 weeks)
- Change in cerebral pulsatility - middle cerebral arteries(Baseline and post-intervention at 12 weeks)
- Change in peripheral endothelial function(Baseline and post-intervention at 12 weeks)
- Central arterial stiffness(Baseline and post-intervention at 12 weeks)