Acute Strawberry Intake on Endothelial Function
Condition: Healthy
Study type: Interventional

Summary: 
      The primary objectives of the study are (1) to evaluate the effects of acute dietary
      strawberry intake on measures of vascular function in healthy adults following a meal
      challenge, (2) to evaluate the effects of acute dietary strawberry intake on metabolic
      status, and (3) to assess intervention-associated metabolite and inflammatory signatures and
      their relationship to vascular function.
    

Detailed description: 
      This study is a randomized, 2-arm, single-blinded, within subject cross-over trial focused on
      evaluating the effects of acute dietary strawberry intake on measures of vascular function,
      metabolic status, as well as metabolite and inflammatory signatures and their relationship to
      vascular function in healthy adults following a meal challenge.

      A planned sample size of 15 will be enrolled into the study. This study will require one
      initial screening visit and 2 study visits. This study will take approximately 1 week 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, subjects will be invited to participate in the study
      for 2 study days. Subjects will be instructed to maintain their usual diet pattern and
      physical activity throughout study duration.

      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 and ultrasound measurement throughout the
      visit. After evaluation of subject's health status (via anthropometric, vital sign and blood
      glucose measurements and in-person interview), a Licensed Health Care Professional 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. A baseline FMD procedure will be completed
      immediately after baseline blood sample collection. Afterwards, subjects will be randomized
      to receive the strawberry powder treatment or placebo based on randomized treatment sequences
      for 2 study visits immediately after fasting blood draw. The sequences of receiving the
      supplement at each visit will be randomly assigned to one of 2 following sequences: A-B or
      B-A Each study visit will involve with blood samples collection at time points 0 (fasting),
      1, 2, 4, 6, and 24 hour (h) for assessment of change in metabolites and inflammatory
      signatures. FMD procedure will be conducted after completing the baseline blood draw and
      later at 2h, 4h, 6h, and 24h. A standard breakfast will be provided immediately after the 0h
      blood collection.
    

Intervention name(s): Active drink; Placebo drink
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): The freeze-dried strawberry powder (25 g) in active drink; Placebo drink
Other intervention name(s): 25g strawberry drink
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Randomized, single-blind, 2-arm, placebo-controlled, within subject cross-over trial, featuring a repeated postprandial sampling paradigm
Masking: Single (Participant)
Primary purpose: Other
Keywords: strawberry; monocytes; endothelial function