Low Carbohydrate Portfolio or "Eco-Atkins" Diet

May 17, 2013 updated by: University of Toronto
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment

30

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5C 2T2
        • Risk Factor Modification Centre, St. Michael's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Eco-Atkins diet
Other: Eco-Atkins diet (high vegetable protein and vegetable fat)
Active Comparator: NCEP diet
Other: NCEP diet

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Toronto

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2005

Study Completion

December 1, 2006

Study Registration Dates

First Submitted

November 16, 2005

First Submitted That Met QC Criteria

November 16, 2005

First Posted (Estimate)

November 21, 2005

Study Record Updates

Last Update Posted (Estimate)

May 20, 2013

Last Update Submitted That Met QC Criteria

May 17, 2013

Last Verified

May 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REB 05-025

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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