Clinical trial NCT06855953: Vitamin K and Cognition in Coronary Heart Disease (NutriCog)
Official title: Vitamin K Supplementation to Improve Cognition of Patients With Coronary Heart Disease: a Randomized Controlled Pilot Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Coronary Heart Disease
Keywords: Coronary heart disease (CHD)
Cognition
Cerebral vasoreactivity
Nutrition
Heart disease
Cardiovascular disease
Vitamins
Micronutrients
Vitamin K
Vitamin K1
Lead sponsor: Montreal Heart Institute
Sponsor class: OTHER
First posted: 2025-03-04
Enrollment: 40
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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)

Detailed description: 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

Eligibility criteria: 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

Primary outcomes:
measure: Change in general cognitive functioning
timeFrame: Baseline and post-intervention at 12 weeks
measure: Change in processing speed
timeFrame: Baseline and post-intervention at 12 weeks
measure: Change in executive functions
timeFrame: Baseline and post-intervention at 12 weeks
measure: Change in episodic memory
timeFrame: Baseline and post-intervention at 12 weeks
Secondary outcomes:
measure: Change in cerebral autoregulation - middle cerebral arteries
timeFrame: Baseline and post-intervention at 12 weeks
measure: Change in cerebral pulsatility - middle cerebral arteries
timeFrame: Baseline and post-intervention at 12 weeks
measure: Change in peripheral endothelial function
timeFrame: Baseline and post-intervention at 12 weeks
measure: Central arterial stiffness
timeFrame: Baseline and post-intervention at 12 weeks
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Montreal Heart Institute
state: Quebec
Study officials:
affiliation: Université de Montréal
name: Guylaine Ferland, PhD
role: PRINCIPAL_INVESTIGATOR
References: