Glycemic Response Clinical Trial
Official title:
The Impact of Avocado Fruit on Postprandial Markers of the Glycemic Response, Satiety/Appetite and Cardiometabolic Risk: An Acute Dose Response Study
The primary goal is to characterize the acute effects of avocado intake on glycemic and satiety/ appetite responses in relatively healthy overweight / obese adults. The secondary goal is to investigate risk factors for cardio-metabolic disease.
The trial is a single center randomized, 3-arm, controlled, within-subject crossover study
utilizing a multiple sampling, repeated measures paradigm. The trial will test 3 treatment
conditions in 30 relatively healthy men and women 25-60 years of age. Study treatments
include Control (without avocado), Test Meal 1 (1/2 avocado; ~68g), and Test Meal 2 (1
Avocado; ~136g).
Subjects will be required to meet several inclusion and exclusion criteria, which will be
assessed through online and clinic mechanisms, including questionnaires, blood analysis and
anthropometric measures. Eligible subjects will be invited to participate in the study. Each
subject will be asked to come for one Information Session/Screening Visit, one Pre-Study
Visit, three dinner pick-ups (the day before each test day visit) and three Test Day Visits.
Subjects will be randomized to receive test treatments based on randomization schedule at the
Pre-Study Visit.
During the Pre-Study Visit subjects will be instructed on the process for completing study
questionnaires and counseled to restrict avocado intake and intake of colored plant foods
rich in phytonutrients the 3 days prior to each Test Day Visit. They will be asked to
restrict alcohol intake, coffee/tea/ caffeinated beverage intake and moderate / vigorous
physical activity and to drink plenty of water to maintain hydration in the 24 h prior to
each Test Day Visit. They will be instructed to come to the CNRC the day before each Test Day
Visit to pick up their dinner meal and evening snack. Subjects will be asked to get at least
7 hours sleep and to come to the CNRC after an overnight fast of 10 h on each Test Day Visit.
Each Test Day Visit will require subjects to be in the clinic for ~7 h to complete all
baseline and post challenge meal testing procedures. Subjects will be evaluated for
compliance with the protocol (diet, exercise, sleep, fasting), have their body weight and
blood pressure measured and baseline flow mediated dilation (FMD) will be recoded before
placement of a catheter and baseline blood sample is taken. Baseline subjective satiety will
be measured by visual analogue scale (VAS) just before consuming one of the 3 breakfast
treatment meals. FMD will be measured at 2 time points after breakfast and blood samples and
VAS questionnaires will be collected at multiple time points over the 6 h postprandial
period.
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