Naturopathic Treatment for the Prevention of Cardiovascular Disease

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00718796

Acronym

Cardio pilot

Enrollment

300

Registered

2008-07-21

Start date

2008-04-30

Completion date

2009-10-31

Last updated

2010-05-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular Disease

Keywords

cardiovascular disease, naturopathic medicine, natural health products, lifestyle intervention, dietary advice, coronary heart disease

Brief summary

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

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.

Interventions

OTHERNaturopathic medicine. May include: fish oil, plant sterols, soluble fiber, cinnamon, coQ10 and exercise

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.

OTHERConventional medical treatment (Atorvastatin,Fluvastatin,Lovastatin,Pravastatin,Rosuvastatin,Simvastatin)

Will vary according to individual - not standardized and likely to include statins.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Metabolic syndrome	1 year
General Cardiovascular Risk Profile: Framingham Heart Study	1 year

Secondary

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

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 8, 2026