This study is designed to test the ability of a comprehensive naturopathic approach to reduce important risk factors for the development of cardiovascular disease. Treatment will take place over the course of one year and the comparator/control group will be followed by their medical doctors and be given conventional care.
Interventions will consist of an individualized treatment approach guided by an expert panel of clinicians who treat patients with cardiovascular disease. These interventions will consist of a combination of dietary, lifestyle and specific recommendations for supplementation. As this is a pragmatic study, blinding will not be attempted nor is appropriate.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
300
Individualized according to needs of each participant and willingness to comply. Intervention to include lifestyle modification, dietary changes and supplementation using natural health products as recommended by naturopathic practitioner.
Will vary according to individual - not standardized and likely to include statins.
Canadian College of Naturopathic Medicine
Toronto, Ontario, Canada
Metabolic syndrome
Time frame: 1 year
General Cardiovascular Risk Profile: Framingham Heart Study
Time frame: 1 year
Adverse events
Time frame: 1 year
HbA1C
Time frame: 1 year
Compliance with naturopathic interventions
Time frame: 1 year
Quality of Life (Short-form 36)
Time frame: 1 year
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