Vitamin K and Cognition in Coronary Heart Disease (NutriCog) (Nutricog)

February 25, 2025 updated by: Montreal Heart Institute

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

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)

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Canada
    • Quebec
      • Montreal, Quebec, Canada, H1T 1C8
        • Montreal Heart Institute
        • Contact:
        • Principal Investigator:
          • Guylaine Ferland, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dietary Supplement: Vitamin K
Participants receive 0.5 mg/day phylloquinone orally for 12 weeks
Dietary supplement: Vitamin K
Participants receive 0.5 mg/day phylloquinone orally for 12 weeks
Placebo Comparator: Dietary Supplement: Placebo
Participants receive daily placebo for 12 weeks
Dietary supplement: Placebo
Participants receive daily placebo for 12 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Baseline and post-intervention at 12 weeks
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
Baseline and post-intervention at 12 weeks
Change in executive functions
Time Frame: 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
Baseline and post-intervention at 12 weeks
Change in episodic memory
Time Frame: 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
Baseline and post-intervention at 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Baseline and post-intervention at 12 weeks
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
Baseline and post-intervention at 12 weeks
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
Baseline and post-intervention at 12 weeks
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
Baseline and post-intervention at 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Montreal Heart Institute

Investigators

  • Principal Investigator: Guylaine Ferland, PhD, Université de Montréal

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 17, 2025

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

March 1, 2027

Study Registration Dates

First Submitted

February 20, 2025

First Submitted That Met QC Criteria

February 25, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 25, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022-3025
  • (FRN) 183781_1 (Other Grant/Funding Number: Canadian Institutes of Health Research (CIHR))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The study protocol will be published

IPD Sharing Time Frame

Study protocol will be submitted for publication once the study registration process is completed

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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