Vitamin K and Cognition in Coronary Heart Disease (NutriCog) (NCT06855953) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Vitamin K and Cognition in Coronary Heart Disease (NutriCog)
Canada40 participantsStarted 2025-03-17
Plain-language summary
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)
Who can participate
Age range60 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
What they're measuring
1
Change in general cognitive functioning
Timeframe: Baseline and post-intervention at 12 weeks
2
Change in processing speed
Timeframe: Baseline and post-intervention at 12 weeks
3
Change in executive functions
Timeframe: Baseline and post-intervention at 12 weeks
4
Change in episodic memory
Timeframe: Baseline and post-intervention at 12 weeks