Low Carbohydrate Portfolio or "Eco-Atkins" Diet

This study has been completed.
Sponsor:
Information provided by:
University of Toronto
ClinicalTrials.gov Identifier:
NCT00256516
First received: November 16, 2005
Last updated: May 17, 2013
Last verified: May 2013
  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
Other: Eco-Atkins diet (high vegetable protein and vegetable fat)
Other: NCEP diet
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment
Official Title: Low Carbohydrate Portfolio or "Eco-Atkins" Diet

Resource links provided by NLM:


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: April 2005
Estimated Study Completion Date: December 2006
Arms Assigned Interventions
Experimental: Eco-Atkins diet Other: Eco-Atkins diet (high vegetable protein and vegetable fat)
Active Comparator: NCEP diet Other: NCEP diet

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00256516     History of Changes
Other Study ID Numbers: REB 05-025
Study First Received: November 16, 2005
Last Updated: May 17, 2013
Health Authority: Canada: Health Canada

Keywords provided by University of Toronto:
Diet Therapy

Additional relevant MeSH terms:
Cardiovascular Diseases
Hypercholesterolemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on August 21, 2014