The Cholesterol Lowering Effects of Strawberry
Condition: Hypercholesterolemia; Glycemic Response
MeSH terms: Hypercholesterolemia
Study type: Interventional

Summary: 
      Primary objective is to assess strawberry intake on LDL cholesterol and its association with
      atherosclerosis development.
    

Detailed description: 
      The trial is designed as a randomized, 2-arm, 2-sequence, within-subject, cross-over, chronic
      feeding study. The arms of the study will include regular consumption of a strawberry or
      strawberry-placebo powder equivalent to ~3.5 servings of strawberries/day (50g) freeze-dried
      strawberry powder (provided twice a day, 25 grams each time >6h apart).

      A planned sample size of 50 men and women will be enrolled into the study. This study will
      require one initial screening visit, 4 study visits, and 6 weekly visits. This study will
      take approximately 12 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), fasting blood draw, 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 before study day 1 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 Licensed health care professional will take a fasting blood draw with
      a butterfly needle. Subjects will be randomized to receive a placebo or treatment beverage
      based on randomized treatment sequences at 4 study visits. The sequences of receiving the
      beverage treatments at each visit will be randomly assigned to one of two of following
      sequences: placebo- treatment beverage or treatment beverage -placebo.

      Each study visit will involve blood sample collection at time points 0h (fasting) for
      assessment of change in plasma lipid and lipoprotein markers. Each study visit will involve a
      2 flow mediated dilatation procedure to assess endothelial function.
    

Intervention name(s): Active Treatment Beverage; Placebo Treatment Beverage
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Strawberry; Placebo
Other intervention name(s): Active Comparator; Placebo Comparator
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Nutrition; Polyphenols; Berries; Lipid Panels