Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
Low Carbohydrate Portfolio or "Eco-Atkins" Diet
This study is ongoing, but not recruiting participants.
Sponsored by: University of Toronto
Information provided by: University of Toronto
ClinicalTrials.gov Identifier: NCT00256516
  Purpose

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.


Condition Intervention Phase
Hypercholesterolemia
Cardiovascular Diseases
 Procedure: Eco-Atkins diet (high vegetable protein and vegetable fat)
 Phase II

Genetics Home Reference related topics: hypercholesterolemia
MedlinePlus related topics: Cholesterol Weight Control
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Single Blind, Active Control, Parallel Assignment
Official Title: Low Carbohydrate Portfolio or "Eco-Atkins" Diet

Further study details as provided by University of Toronto:

Primary Outcome Measures:
  • total and low-density lipoprotein (LDL) cholesterol
  • LDL:HDL cholesterol ratio
  • weight reduction

Secondary Outcome Measures:
  • 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

Estimated Enrollment: 30
Study Start Date: September 2005
Estimated Study Completion Date: December 2006
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.

  Eligibility

Ages Eligible for Study:   21 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00256516

Locations
Canada, Ontario
Risk Factor Modification Centre, St. Michael's Hospital
Toronto, Ontario, Canada, M5C 2T2
Sponsors and Collaborators
University of Toronto
Investigators
Principal Investigator: David JA Jenkins, MD, PhD, DSc University of Toronto and St. Michael's Hospital
  More Information

Study ID Numbers: REB 05-025
Study First Received: November 16, 2005
Last Updated: July 7, 2008
ClinicalTrials.gov Identifier: NCT00256516  
Health Authority: Canada: Health Canada

Keywords provided by University of Toronto:
Diet Therapy

Study placed in the following topic categories:
Metabolic Diseases
Hyperlipidemias
Metabolic disorder
 Hypercholesterolemia
Dyslipidemias
Lipid Metabolism Disorders

Additional relevant MeSH terms:
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 13, 2009



U.S. National Library of Medicine,  Contact Help Desk
U.S. National Institutes of Health,  U.S. Department of Health & Human Services,
USA.gov,  Copyright,  Privacy,  Accessibility,  Freedom of Information Act

U.S. National Institutes of Health U.S. National Library of Medicine U.S. Department of Health & Human Services