Coronary Heart DiseaseNutricogNCT06855953
Vitamin K and Cognition in Coronary Heart Disease (NutriCog)
A study testing Vitamin K in people with Coronary Heart Disease, run by Montreal Heart Institute at 1 site in Canada.
Trial 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) Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Coronary Heart Disease
- What is being tested?
- Vitamin K
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- 17 Mar 2025to Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site
Montreal Heart Institute
Montreal, Quebec, H1T 1C8
Guylaine Ferland, PhD, +1 (514) 376-3330 ext. 3374, guylaine.ferland@umontreal.ca
Guylaine Ferland, PhD
About this study
Official title: 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)
Read the 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
- Conditions
- Coronary Heart Disease
- Being tested
- Vitamin K, Placebo
- Keywords
- Coronary heart disease (CHD), Cognition, Cerebral vasoreactivity, Nutrition, Heart disease, Cardiovascular disease, Vitamins, Micronutrients, Vitamin K, Vitamin K1
- Medical subject headings
- Coronary Disease, Heart Diseases, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin KDietary supplement
Participants receive 0.5 mg/day phylloquinone orally for 12 weeks
PlaceboDietary supplement
Participants receive daily placebo for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Dietary Supplement: Vitamin K | Experimental | Participants receive 0.5 mg/day phylloquinone orally for 12 weeks Receives: Dietary Supplement: Vitamin K |
| Dietary Supplement: Placebo | Placebo comparator | Participants receive daily placebo for 12 weeks Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in general cognitive functioning
Montreal Cognitive Assessment (0-30 score, with a higher score indicating a better cognitive functioning)
Measured: Baseline and post-intervention at 12 weeks
Change in processing speed
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
Measured: Baseline and post-intervention at 12 weeks
Change in executive functions
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
Measured: Baseline and post-intervention at 12 weeks
Change in episodic memory
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
Measured: Baseline and post-intervention at 12 weeks
Secondary outcomes (4)
Change in cerebral autoregulation - middle cerebral arteries
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)
Measured: Baseline and post-intervention at 12 weeks
Change in cerebral pulsatility - middle cerebral arteries
Pulsatility will be measured as the normalized difference of relative blood flow velocities between systole and diastole, using TCD in the middle cerebral arteries
Measured: Baseline and post-intervention at 12 weeks
Change in peripheral endothelial function
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
Measured: Baseline and post-intervention at 12 weeks
Central arterial stiffness
Central arterial stiffness will be assessed by measuring the carotid-femoral pulse-wave velocity (cfPWV), using a non-invasive surface tonometer
Measured: Baseline and post-intervention at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2025
- Study start17 Mar 2025 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Heart DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Montreal Heart Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Guylaine Ferland, PhD, Principal investigator, Université de Montréal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06855953
- Sponsor's protocol ID
- 2022-3025
- Other IDs
- (FRN) 183781_1
- Acronym
- Nutricog
- Status last verified
- Feb 2025
- First submitted
- 20 Feb 2025
- Last updated
- 4 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The study protocol will be published
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vitamin K Supplementation to Improve Cognition of Patients With Coronary Heart Disease: a Randomized Controlled Pilot Study
- ClinicalTrials.gov ID
- NCT06855953
- Acronym / sponsor ID
- Nutricog / 2022-3025
- Conditions
- Coronary Heart Disease
- Keywords
- Coronary heart disease (CHD), Cognition, Cerebral vasoreactivity, Nutrition, Heart disease, Cardiovascular disease, Vitamins, Micronutrients
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Montreal Heart InstituteUniversity, hospital or other
- Study start
- 17 Mar 2025 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 4 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dietary Supplement: Vitamin K | Experimental | Dietary Supplement: Vitamin KParticipants receive 0.5 mg/day phylloquinone orally for 12 weeks |
| Dietary Supplement: Placebo | Placebo comparator | Dietary Supplement: PlaceboParticipants receive daily placebo for 12 weeks |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (9 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitamin KParticipants receive 0.5 mg/day phylloquinone orally for 12 weeks | Dietary supplement | Dietary Supplement: Vitamin K |
| PlaceboParticipants receive daily placebo for 12 weeks | Dietary supplement | Dietary Supplement: Placebo |
Primary outcome
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)
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
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
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
4 secondary outcomes
Change in cerebral autoregulation - middle cerebral arteries
Time frame: Baseline and post-intervention at 12 weeks
Change in cerebral pulsatility - middle cerebral arteries
Time frame: Baseline and post-intervention at 12 weeks
Change in peripheral endothelial function
Time frame: Baseline and post-intervention at 12 weeks
Central arterial stiffness
Time frame: Baseline and post-intervention at 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2025.
- Individual participant dataSharing planned: Yes. The study protocol will be published
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Guylaine Ferland, PhD principal investigator
Université de Montréal
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vitamin K in people with Coronary Heart Disease, run by Montreal Heart Institute at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 4 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Guylaine Ferland, PhD (+1 (514) 376-3330 ext. 3374, guylaine.ferland@umontreal.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in general cognitive functioning (time frame: Baseline and post-intervention at 12 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2025.