Low Carbohydrate Portfolio or "Eco-Atkins" Diet
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ClinicalTrials.gov Identifier: NCT00256516 |
Recruitment Status :
Completed
First Posted : November 21, 2005
Last Update Posted : May 20, 2013
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Tracking Information | ||||
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First Submitted Date ICMJE | November 16, 2005 | |||
First Posted Date ICMJE | November 21, 2005 | |||
Last Update Posted Date | May 20, 2013 | |||
Study Start Date ICMJE | April 2005 | |||
Primary Completion Date | Not Provided | |||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE |
total and LDL cholesterol, LDL:HDL cholesterol ratio, weight reduction | |||
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Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
Blood pressure, HDL cholesterol, HDL2 and HDL3, triglyceride, apolipoprotein A1 and B, Lp(a) and LDL particle size, glucose, insulin and measurements of oxidative stress. | |||
Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Low Carbohydrate Portfolio or "Eco-Atkins" Diet | |||
Official Title ICMJE | Low Carbohydrate Portfolio or "Eco-Atkins" Diet | |||
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 dramatic rather than modest reductions in blood lipids with weight loss. In effect this will represent an exchange of saturated fat and animal protein for healthy monounsaturated and polyunsaturated fats and vegetable proteins with significant effects on blood lipids while still encouraging weight loss. | |||
Detailed Description | Subjects: Thirty overweight hyperlipidemic subjects who wish to lose weight. Design:
Study Details: Participants will come after a 12h overnight fast to the Risk Factor Modification Centre at St. Michael's Hospital or the Department of Nutritional Sciences, University of Toronto immediately prior to commencement of each treatment phase and at weekly intervals during the metabolic study and monthly during the ad libitum study. Prior to the start of the study, participants will be instructed on details of the study diet protocol. They will also be asked to maintain a constant level of physical activity throughout the course of the study. At all visits, body weight (in kg) will be obtained in indoor clothing, without shoes, and blood pressure will be taken twice in the dominant arm after participants have been seated for at least 20 minutes. Height (in cm) will be recorded at the first visit. Body composition measurements will be measured using bioelectric impedance at baseline and week 4 of the metabolic phase, and months 3 and 6 of the ad libitum phase. Throughout the study period, participants will maintain the diet prescribed on their initial visit. At each visit, participants will provide a fasting blood sample and seven-day food records will be collected. During the last week of the metabolic and ad libitum study, 24h fecal and urine collections will be completed. |
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Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 2 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE |
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Study Arms ICMJE |
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Enrollment ICMJE |
30 | |||
Original Enrollment ICMJE | Same as current | |||
Study Completion Date ICMJE | December 2006 | |||
Primary Completion Date | Not Provided | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 21 Years to 70 Years (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | Yes | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Canada | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00256516 | |||
Other Study ID Numbers ICMJE | REB 05-025 | |||
Has Data Monitoring Committee | Not Provided | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Not Provided | |||
Study Sponsor ICMJE | University of Toronto | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | University of Toronto | |||
Verification Date | May 2013 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |