Status:
COMPLETED
Low Carbohydrate Portfolio or "Eco-Atkins" Diet
Lead Sponsor:
University of Toronto
Conditions:
Hypercholesterolemia
Cardiovascular Diseases
Eligibility:
All Genders
21-70 years
Phase:
PHASE2
Brief Summary
Exchange of the butter, eggs, cheese and meat in the Atkins diet for soy protein foods, other vegetable proteins including gluten and vegetable fats, nuts, avocado, olive and canola oil will result in...
Detailed Description
Subjects: Thirty overweight hyperlipidemic subjects who wish to lose weight. Design: * Protocol (Metabolic Study): will be randomized to either the Eco-Atkins diet (15 subjects) or NCEP diet (15 sub...
Eligibility Criteria
Inclusion
- Men and postmenopausal women between the age of 21 and 70
- Body mass index \> 27 kg/m2 and whose body weight has remained constant over the last 6 months preceding the onset of the study.
- Fasting plasma LDL cholesterol concentration \> 3.4 mmol/L at diagnosis.
- Treated by diet.
- Alcohol intake \< 14 drinks per week.
- Fasting plasma triglyceride concentration \> 0.5 mmol/L and \< 5.0 mmol/L.
- Living within a 40 km radius of St. Michael's Hospital or the University of Toronto.
Exclusion
- Premenopausal women due to the fluctuation of blood lipids during the menstrual cycle.
- Taking lipid lowering medications. (However, with their physician's approval those who wish to join but are already taking cholesterol-lowering medications may join the study providing the medications are stopped for at least two weeks before starting the study and throughout the study.)
- Evidence of major cardiovascular event (stroke or myocardial infarction) within the past 6 months.
- Positive molecular diagnosis of familial hypercholesterolemia.
- Secondary causes of hypercholesterolemia (hypothyroidism, renal or liver disease).
- Diabetes
- Uncontrolled high blood pressure (\> 140/90mmHg).
- Major disability or disorder such as liver disease, renal failure or cancer or with major surgery \< 6 months prior to randomization.
- LDL-C levels below 3.0 mmol/L on a Step 2 diet prior to randomization.
- Postmenopausal women on hormone replacement therapy
- Smokers
- Patients with food allergies.
- Patients with a history of any form of cancer or are considered at high risk for cancer. However, if such patients wish to join the study, we, the researchers, would like them to obtain the approval of their oncologist or responsible physician prior to enrollment in the study.
Key Trial Info
Start Date :
April 1 2005
Trial Type :
INTERVENTIONAL
End Date :
December 1 2006
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00256516
Start Date
April 1 2005
End Date
December 1 2006
Last Update
May 20 2013
Active Locations (1)
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1
Risk Factor Modification Centre, St. Michael's Hospital
Toronto, Ontario, Canada, M5C 2T2