Absorption and Metabolic Profiles of a Sugar-based Beverage

Overview

Primary objective is to determine absorption profile of a sugar-based beverage on inflammatory mechanism by timing of beverage consumption relative to meal intake. Secondary objective is to determine absorption profile of a sugar-based beverage on oxidative and metabolic mechanism by timing of beverage consumption relative to meal intake. The results will be served as an internal reference or negative control group to compare with polyphenol containing studies from other studies. Each subject will receive 3 identical placebo drinks at each time points: fasting (0h), with standardized breakfast meal (2h), and 2 hours after the breakfast meal (4h). A planned size of 12 will be recruited into this part of the study. This study is a single-arm design utilizing a multiple sampling, and repeated measures paradigm to evaluate timing influence of consumption of sugar-based beverage associated acute effect on inflammatory markers.

A planned sample size of 12 will be recruited into the study. This study will require one initial screening visit, one pre-study visit, and 1 study visit. The study will take 1-2 weeks per subject to complete. The initial screening visit will provide subject informed consent document and determine subject eligibility through height and weight measurements, vital signs, blood glucose test (finger prick), and completion of a survey related to general eating, health, and exercise habits. If willing and eligible to participate, a 3-day food record (2 weekdays and 1 weekend day) will be instructed at initial screening visit and collected at a pre-study visit to assess subjects' baseline dietary intake pattern. After reviewing baseline food records, subjects will be instructed to avoid any berry products throughout the study and follow a strictly limited polyphenolic diet for 3 days prior to the study visit, while maintaining their usual diet pattern and physical activity. Prior to 10-hr study visit, a dinner meal will be provided the day before the study visit to control the second meal effect from the food and beverage intake of the night before the study visit. Subject will arrive at the study visit fasted for at least 10 hours, well hydrated and rested. Each study visit will require blood draws throughout the visit. After pre-study procedures (height, weight, waist circumferences, vital sign, and blood glucose measurements) , a registered nurse will place a catheter in subject's arm for the purpose of multiple blood sample collections and take the initial blood draw at fasting. Thereafter, blood sample collection will occur every 1 hour for the next 10 hours. During the 10-hr study visit, subject will drink one of 3 identical placebo drinks at fasting (right after fasting blood draw), 2nd placebo drink with the breakfast meal (2 hrs after fasting blood draw) and the 3rd placebo drink at 2 hours after the breakfast meal (4 hrs after fasting blood draw). Premenopausal female subjects will be studied during the follicular phase of their menstrual cycle because food intake tends to be more stable during the follicular phase (days 1-13) than during the luteal phase (days 14-28) when the rise in progesterone levels decrease satiety often resulting in increased intake.