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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
Sponsor:
Information provided by:
University of Toronto

Tracking Information
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
 (submitted: April 10, 2007)
  • total and low-density lipoprotein (LDL) cholesterol
  • LDL:HDL cholesterol ratio
  • weight reduction
Original Primary Outcome Measures  ICMJE
 (submitted: November 16, 2005)
total and LDL cholesterol, LDL:HDL cholesterol ratio, weight reduction
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 10, 2007)
  • blood pressure
  • high-density lipoprotein (HDL) cholesterol
  • HDL2 and HDL3, triglyceride, apolipoprotein A1 and B, Lp(a) and LDL particle size
  • glucose, insulin and measurements of oxidative stress
Original Secondary Outcome Measures  ICMJE
 (submitted: November 16, 2005)
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:

  • Protocol (Metabolic Study): will be randomized to either the Eco-Atkins diet (15 subjects) or NCEP diet (15 subjects). The diets will be provided for the one month period with the aim of inducing the same weight loss (5 kg) as seen in the first month of the published reports on the Atkins diet. The diets will provide about 60% of estimated energy requirements. Subjects will be provided with their diets at weekly intervals by courier and intakes adapted to ensure that they achieve their target weight loss goal. Fasting weight will be taken at weekly intervals together with blood pressure and blood for lipids, glucose and insulin assessment.
  • Protocol (Ad Libitum Study): After completing the metabolic phase of the study, the thirty subjects will be asked to continue with the diet to which they were randomized for a further 6-month period. During this ad libitum trial, study foods will not be provided. This longer less tightly controlled study will establish the value of this diet in "real life" situations. This will be required to support our shorter term, well-controlled more detailed metabolic study. Fasting weight will be taken at monthly intervals together with blood pressure and blood for lipids, glucose and insulin assessment.

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Treatment
Condition  ICMJE
  • Hypercholesterolemia
  • Cardiovascular Diseases
Intervention  ICMJE
  • Other: Eco-Atkins diet (high vegetable protein and vegetable fat)
  • Other: NCEP diet
Study Arms  ICMJE
  • Experimental: Eco-Atkins diet
    Intervention: Other: Eco-Atkins diet (high vegetable protein and vegetable fat)
  • Active Comparator: NCEP diet
    Intervention: Other: NCEP diet
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: November 16, 2005)
30
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE December 2006
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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 Criteria:

  • 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
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
Principal Investigator: David JA Jenkins, MD, PhD, DSc University of Toronto and St. Michael's Hospital
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