Replacing Refined Carbohydrates With Healthy Fats on Cardio-metabolic Markers
Condition: Pre-diabetes; Metabolic Syndrome
MeSH terms: Metabolic Syndrome; Prediabetic State; Glucose Intolerance; Syndrome
Study type: Interventional

Summary: 
      The primary goal is to to characterize the effects of consuming 1 avocado fruit 7 days / week
      (5-7 days is acceptable) compared to a no avocado relatively low fat, carbohydrate control
      treatment over a 12 week period on insulin sensitivity as measured by the Matsuda composite
      index of insulin sensitivity (MISI).
    

Detailed description: 
      The trial is designed as a randomized, controlled, statistician blinded, 2-arm parallel study
      to investigate the effects of avocado consumption compared to non-avocado control foods which
      have opposing macronutrients (avocado is relatively higher in fat and in low carbohydrate and
      the control foods will be low fat, high carbohydrate options) on indices of cardiometabolic
      health over a 12 week period.

      The trial will test 2 treatment conditions in pre-diabetic men and women 25-60 years of age
      with metabolic syndrome. One hundred twenty men and women will be recruited, aiming for a
      completer set of 96 subjects. Qualified Subjects will be randomized to receive 1 of 2 test
      treatments based on randomization schedule from a computer generated randomization schedule.

      Study treatments include:

        -  Control (CT) diet plan with at least 1 serving of a low fat, low fiber, high glycemic
           carbohydrate and eliminate avocado 7 days / week (5-7 days is acceptable) over a 12 week
           period.

        -  Active treatment (AT) diet plan will include 1 Avocado 7 days/week (5-7 days is
           acceptable) over a 12 week period.

      Each subject will be asked to come for one Screening Visit, 9 interim food pick-up/compliance
      visits and 4 Test Day Visits. The four main Test Day visits will occur at week 0 (day 1;
      baseline), end of week 4, at the end of week 8 and at the end of week 12. Interim Visits will
      occur at week 1, 2, 3, 5, 6, 7, 9, 10 and 11. Subjects will pick-up study foods, answer
      questionnaires, receive dietary counseling, confirm diet compliance during interim visits.
      They will also be asked to complete online 24 hour food recalls up to once per each week of
      the study. Each of the 4 Test Day Visits will last about 2-3.5 h and involve blood pressure
      (BP) measurements, a fasting blood sample collection and anthropometric, body composition
      assessment. In addition, an oral glucose tolerance test (OGTT) will be performed at week
      0/day 1 and at the end of week 12/day.
    

Intervention name(s): Active; Control
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Active Treatment Diet Plan; Control Diet Plan
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Pre-diabetes; Metabolic syndrome; Matsuda composite index of insulin sensitivity (MISI); Blood glucose; Insulin response; HbA1c; Lipid; Inflammation