Last updated on July 2018

Replacing Refined Carbohydrates With Healthy Fats on Cardio-metabolic Markers


Brief description of study

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 Study 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.

Clinical Study Identifier: NCT02695433

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Eunyoung Park, MS, RD

Clinical Nutrition Research Center
Chicago, IL United States
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