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| Name | Class |
|---|---|
| Canada Post Corporation | UNKNOWN |
| Canadian Union of Postal Workers | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Individualized naturopathic treatment consisting of dietary and lifestyle advice and individualized supplementation |
|
| 2 | Active Comparator | Current care control provided by participants' medical doctor |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Naturopathic medicine. May include: fish oil, plant sterols, soluble fiber, cinnamon, coQ10 and exercise | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Metabolic syndrome | 1 year | |
| General Cardiovascular Risk Profile: Framingham Heart Study | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events | 1 year | |
| HbA1C | 1 year | |
| Compliance with naturopathic interventions |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dugald Seely, ND | Canadian College of Naturopathic Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Canadian College of Naturopathic Medicine | Toronto | Ontario | M2K 1E2 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24451612 | Derived | Herman PM, Szczurko O, Cooley K, Seely D. A naturopathic approach to the prevention of cardiovascular disease: cost-effectiveness analysis of a pragmatic multi-worksite randomized clinical trial. J Occup Environ Med. 2014 Feb;56(2):171-6. doi: 10.1097/JOM.0000000000000066. | |
| 23630244 | Derived | Seely D, Szczurko O, Cooley K, Fritz H, Aberdour S, Herrington C, Herman P, Rouchotas P, Lescheid D, Bradley R, Gignac T, Bernhardt B, Zhou Q, Guyatt G. Naturopathic medicine for the prevention of cardiovascular disease: a randomized clinical trial. CMAJ. 2013 Jun 11;185(9):E409-16. doi: 10.1503/cmaj.120567. Epub 2013 Apr 29. |
| Label | URL |
|---|---|
| Central facility website | View source |
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|
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| Conventional medical treatment (Atorvastatin,Fluvastatin,Lovastatin,Pravastatin,Rosuvastatin,Simvastatin) | Other | Will vary according to individual - not standardized and likely to include statins. |
|
|
| 1 year |
| Quality of Life (Short-form 36) | 1 year |
| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
| D003327 | Coronary Disease |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D010840 | Phytosterols |
| C024989 | coenzyme Q10 |
| D015444 | Exercise |
| D004032 | Diet |
| D000529 | Complementary Therapies |
| D005395 | Fish Oils |
| D000069059 | Atorvastatin |
| D000924 | Anticholesteremic Agents |
| D000077340 | Fluvastatin |
| D008148 | Lovastatin |
| D017035 | Pravastatin |
| D000068718 | Rosuvastatin Calcium |
| D019821 | Simvastatin |
| ID | Term |
|---|---|
| D013261 | Sterols |
| D002776 | Cholestanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D008563 | Membrane Lipids |
| D008055 | Lipids |
| D064209 | Phytochemicals |
| D001685 | Biological Factors |
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D013812 | Therapeutics |
| D009821 | Oils |
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006538 | Heptanoic Acids |
| D005227 | Fatty Acids |
| D000960 | Hypolipidemic Agents |
| D000963 | Antimetabolites |
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D057847 | Lipid Regulating Agents |
| D045506 | Therapeutic Uses |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D005464 | Fluorobenzenes |
| D006845 | Hydrocarbons, Fluorinated |
| D006846 | Hydrocarbons, Halogenated |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011743 | Pyrimidines |
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