Naturopathic Treatment for the Prevention of Cardiovascular Disease

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Naturopathic Treatment for the Prevention of Cardiovascular Disease: a Pragmatic Randomized Controlled Trial

Conditions
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Cardiovascular Disease

Intervention / Treatment
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* Other: Naturopathic medicine. May include: fish oil, plant sterols, soluble fiber, cinnamon, coQ10 and exercise
* Other: Conventional medical treatment (Atorvastatin,Fluvastatin,Lovastatin,Pravastatin,Rosuvastatin,Simvastatin)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 to 65 years old CUPW worker prescreening indicates higher than normal TC/HDL ratio Exclusion Criteria: Experienced an MI or stroke within past 6 months

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Individualized naturopathic treatment consisting of dietary and lifestyle advice and individualized supplementation | Other: Naturopathic medicine. May include: fish oil, plant sterols, soluble fiber, cinnamon, coQ10 and exercise<br>* 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.<br>* Other names: Exercise;|
| Active Comparator: 2<br>Current care control provided by participants' medical doctor | Other: Conventional medical treatment (Atorvastatin,Fluvastatin,Lovastatin,Pravastatin,Rosuvastatin,Simvastatin)<br>* Will vary according to individual - not standardized and likely to include statins.<br>* Other names: Simvastatin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Metabolic syndrome |  | 1 year | 
| General Cardiovascular Risk Profile: Framingham Heart Study |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events |  | 1 year | 
| HbA1C |  | 1 year | 
| Compliance with naturopathic interventions |  | 1 year | 
| Quality of Life (Short-form 36) |  | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cardiovascular disease, naturopathic medicine, natural health products, lifestyle intervention, dietary advice, coronary heart disease