Low Carbohydrate Portfolio or "Eco-Atkins" Diet
Condition: Hypercholesterolemia; Cardiovascular Diseases
MeSH terms: Cardiovascular Diseases; Hypercholesterolemia
Study type: Interventional
Phase: Phase 2

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.
    

Intervention name(s): Eco-Atkins diet (high vegetable protein and vegetable fat); NCEP diet
Intervention type(s): Other; Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single
Primary purpose: Treatment
Keywords: Diet Therapy