Vitamin K and Cognition in Coronary Heart Disease (NutriCog)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-03-17

Study Completion Date

2027-03-31

Brief Summary

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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)

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Detailed Description

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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

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Coronary Heart Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Dietary Supplement: Vitamin K

Participants receive 0.5 mg/day phylloquinone orally for 12 weeks

Group Type EXPERIMENTAL

Vitamin K

Intervention Type DIETARY_SUPPLEMENT

Participants receive 0.5 mg/day phylloquinone orally for 12 weeks

Dietary Supplement: Placebo

Participants receive daily placebo for 12 weeks

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

Participants receive daily placebo for 12 weeks

Interventions

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Vitamin K

Participants receive 0.5 mg/day phylloquinone orally for 12 weeks

Intervention Type DIETARY_SUPPLEMENT

Placebo

Participants receive daily placebo for 12 weeks

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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

Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No