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

University of Montreal

Status: Not yet enrolling

Conditions: Coronary Heart Disease

Treatments: Dietary Supplement: Placebo; Dietary Supplement: Vitamin K

Study type: Interventional

Funder types: Other

Identifiers

NCT06855953

(FRN) 183781_1 (Other Grant/Funding Number)

2022-3025

Details and patient eligibility

About

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)

Full 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

Enrollment: 40 estimated patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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40 participants in 2 patient groups, including a placebo group

Dietary Supplement: Vitamin K

Experimental group

Description:

Participants receive 0.5 mg/day phylloquinone orally for 12 weeks

Treatment:

Dietary Supplement: Vitamin K

Dietary Supplement: Placebo

Placebo Comparator group

Description:

Participants receive daily placebo for 12 weeks

Treatment:

Dietary Supplement: Placebo