Health TrialsbyHealthPanel

Vitamin K and Cognition in Coronary Heart Disease (NutriCog)

ConditionCoronary Heart Disease
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age60+
SponsorMontreal Heart Institute

About this trial

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)

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Men and women

Age 60 years and older

Medically documented stable Coronary Heart Disease (CHD)

Daily dietary intakes of phylloquinone <150 mcg

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: Dietary Supplement: Vitamin KExperimental treatment 1 intervention
Group B: Dietary Supplement: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change in general cognitive functioning

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

Time frame
Baseline and post-intervention at 12 weeks
2

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

Time frame
Baseline and post-intervention at 12 weeks
3

Change in executive functions

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

Time frame
Baseline and post-intervention at 12 weeks
4

Change in episodic memory

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

Time frame
Baseline and post-intervention at 12 weeks

Secondary outcomes

1

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)

Time frame
Baseline and post-intervention at 12 weeks
2

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

Time frame
Baseline and post-intervention at 12 weeks
3

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

Time frame
Baseline and post-intervention at 12 weeks
4

Central arterial stiffness

Central arterial stiffness will be assessed by measuring the carotid-femoral pulse-wave velocity (cfPWV), using a non-invasive surface tonometer

Time frame
Baseline and post-intervention at 12 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Montreal Heart Institute

Lead sponsor

Source ClinicalTrials.gov

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