Vitamin K and Cognition in Coronary Heart Disease (NutriCog)

Not Applicable

Not yet recruiting

• Conditions: Coronary Heart Disease

• Registration Number: NCT06855953
• Lead Sponsor: Montreal Heart Institute

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

Study Timeline

• Status Verified: 2025-02
• Study First Submitted: 2025-02-20
• Study First Submitted QC: 2025-02-25
• Last Update Submitted: 2025-02-25
• Study First Posted: 2025-03-04
• Last Update Posted: 2025-03-04
• Study Start: 2025-03-17
• Primary Completion: 2026-12
• Study Completion: 2027-03

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in executive functions	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	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
Change in general cognitive functioning	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	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

Secondary Outcome Measures

Name	Time	Method
Change in cerebral autoregulation - middle cerebral arteries	Baseline and post-intervention at 12 weeks	Variations of cerebral blood flow velocity at the level of the middle cerebral artery will be measured in response to hypercapnic breathing using transcranial Doppler (TCD)
Central arterial stiffness	Baseline and post-intervention at 12 weeks	Central arterial stiffness will be assessed by measuring the carotid-femoral pulse-wave velocity (cfPWV), using a non-invasive surface tonometer
Change in cerebral pulsatility - middle cerebral arteries	Baseline and post-intervention at 12 weeks	Pulsatility will be measured as the normalized difference of relative blood flow velocities between systole and diastole, using TCD in the middle cerebral arteries
Change in peripheral endothelial function	Baseline and post-intervention at 12 weeks	Brachial artery flow-mediated dilation (FMD) will be quantified noninvasively by measuring blood velocity in the brachial artery and its diameter before and after 5 minutes of forearm hypoxia, using a high-resolution ultrasound device

Trial Locations

Locations (1)

Montreal Heart Institute; 🇨🇦 Montreal, Quebec, Canada