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NCT Number: NCT06855953

Vitamin K and Cognition in Coronary Heart Disease (NutriCog)

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)

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Key information

Conditions

Coronary Heart Disease Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Montreal Heart Institute

Montreal, Quebec, H1T 1C8, Canada

Location contact

Guylaine Ferland, PhD

CONTACT

[email protected]

+1 (514) 376-3330 ext. 3374

Guylaine Ferland, PhD

PRINCIPAL_INVESTIGATOR

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vitamin K

Dietary Supplement

Participants receive 0.5 mg/day phylloquinone orally for 12 weeks

Placebo

Dietary Supplement

Participants receive daily placebo for 12 weeks

Primary outcomes

  1. Change in general cognitive functioning

    Time frame: Baseline and post-intervention at 12 weeks

    Montreal Cognitive Assessment (0-30 score, with a higher score indicating a better cognitive functioning)

  2. Change in processing speed

    Time frame: 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

  3. Change in executive functions

    Time frame: Baseline and post-intervention at 12 weeks

    Executive function is assessed using

    • 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)]
    • WAISIV subtests ("Switching" between naming fruit and furniture (60s maximum)]
    • 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

  4. Change in episodic memory

    Time frame: Baseline and post-intervention at 12 weeks

    Episodic memory is assessed using:

    • Rey auditory verbal learning test (RAVLT). Score 0-75, with a higher score indicating a better memory
    • 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

Secondary outcomes

  1. Change in cerebral autoregulation - middle cerebral arteries

    Time frame: 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)

  2. Change in cerebral pulsatility - middle cerebral arteries

    Time frame: 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

  3. Change in peripheral endothelial function

    Time frame: 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

  4. Central arterial stiffness

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

Bouchra Ouliass, B.Sc.

CONTACT

[email protected]

+1 (514) 376-3330 ext. 4043

Guylaine Ferland, PhD

CONTACT

[email protected]

+1 (514) 376-3330 ext. 3374

Sponsors and collaborators

Lead sponsor

Montreal Heart Institute

Other

Registry information

Official study title

Vitamin K Supplementation to Improve Cognition of Patients With Coronary Heart Disease: a Randomized Controlled Pilot Study

Acronym: Nutricog

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Mar 4, 2025
Registry last updated
Mar 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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