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| ID | Type | Description | Link |
|---|---|---|---|
| (FRN) 183781_1 | Other Grant/Funding Number | Canadian Institutes of Health Research (CIHR) |
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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)
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dietary Supplement: Vitamin K | Experimental | Participants receive 0.5 mg/day phylloquinone orally for 12 weeks |
|
| Dietary Supplement: Placebo | Placebo Comparator | Participants receive daily placebo for 12 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vitamin K | Dietary Supplement | Participants receive 0.5 mg/day phylloquinone orally for 12 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in general cognitive functioning | 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 | 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 | Executive function is assessed using
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 | Episodic memory is assessed using:
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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | Baseline and post-intervention at 12 weeks |
| Change in cerebral pulsatility - middle cerebral arteries |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Guylaine Ferland, PhD | Contact | +1 (514) 376-3330 | 3374 | guylaine.ferland@umontreal.ca |
| Bouchra Ouliass, B.Sc. | Contact | +1 (514) 376-3330 | 4043 | Bouchra.Ouliass@icm-mhi.org |
| Name | Affiliation | Role |
|---|---|---|
| Guylaine Ferland, PhD | Université de Montréal | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Montreal Heart Institute | Montreal | Quebec | H1T 1C8 | Canada |
The study protocol will be published
Study protocol will be submitted for publication once the study registration process is completed
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| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D014812 | Vitamin K |
| ID | Term |
|---|---|
| D009285 | Naphthoquinones |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
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| Placebo | Dietary Supplement | Participants receive daily placebo for 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 | 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 | 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 |
| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D010836 | Phytol |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D011083 | Polycyclic Compounds |