Characterization of Wild Blueberry Polyphenols Bioavailability and Kinetic Profile Over 24-hour Period
Condition: Overweight; Obese; Healthy
MeSH terms: Overweight
Study type: Interventional

Summary: 
      Primary objective is to characterize the relative bioavailability and kinetic profile of wild
      blueberry polyphenols over 24-hours period.

      Secondary objective is to examine the relationship between bioavailability and kinetic
      profile of wild blueberry polyphenols on markers of chronic diseases.
    

Detailed description: 
      This study is a randomized, single blinded, 2-arm, within-subjects, placebo-controlled design
      utilizing a multiple sampling, repeated measures paradigm to characterize the bioavailability
      and kinetic profile of wild blueberry polyphenols.

      A planned sample size of 12 will be enrolled into the study. This study will require one
      initial screening visit, one pre-study visit, and 2 study visits. This study will take
      approximately 3-4 weeks per subject to complete.

      The initial screening visit will provide subject with the informed consent document and
      determine subject eligibility through anthropometric measurements, vital signs, fasting blood
      glucose test (finger prick), and completion of a survey relate 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 the Screening Visit and collected at the Pre-study visit to assess
      subjects' baseline dietary intake pattern. Subjects will be instructed to follow a strictly
      limited polyphenolic diet for 7 days prior to the study and throughout their participation
      time, while maintaining their usual diet pattern and physical activity, with counseling by
      staff investigator and/or Registered Dietitian. 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 center in a fasted state for at least 10 hours, well hydrated and
      rested. Each study visit will require blood draws throughout the visit. After evaluation of
      subject's health status (via anthropometric, vital sign and blood glucose measurements and
      in-person interview), 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 in the fasting
      state. Subjects will be randomized to receive a placebo or wild blueberry beverage treatment
      based on randomized treatment sequences at 2 study visits along with 3 standard meals
      (breakfast, lunch and dinner). The sequences of receiving the beverage treatments at each
      visit will be randomly assigned to one of two of following sequences: placebo-wild blueberry
      or wild blueberry-placebo.

      Each study visit will involve with blood samples collection at time points 0 (fasting), 0.25,
      0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10 and 24 hour (h) for assessment of change in plasma
      metabolites of wild blueberry polyphenols and influence of metabolic and inflammation
      markers. Also, urine samples will be collected prior to the study treatment as a baseline and
      all voids over 6 time periods, 0 to 2 h, 2 to 4 h, 4 to 6 h, 6 to 8 h, 8 to 10h and 10 to 24
      h during each study visit to assess wild blueberry polyphenolic metabolites.
    

Intervention name(s): Active Comparator; Placebo Comparator
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Wild Blueberry Beverage; Placebo Beverage
Other intervention name(s): Wild Blueberries; Placebo
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: Wild Blueberries; Polyphenolics