Markers of Atherosclerosis in Overweight, Postmenopausal Women Following Daily Watermelon Consumption
Condition: Postmenopausal; Overweight and Obesity
MeSH terms: Atherosclerosis; Overweight
Study type: Interventional

Summary: 
      The primary purpose of this study is to determine the effectiveness of six weeks of
      watermelon puree supplementation, compared to control (no treatment), on blood antioxidant
      capacity, inflammation markers in the blood, biomarkers of metabolism in the blood, and
      cardiovascular disease markers in the blood, and biomarkers in the blood related to
      watermelon ingestion in overweight post-menopausal women. The secondary purpose is to compare
      body composition and body mass between the watermelon supplement group and the control group.
    

Detailed description: 
      ORIENTATION AND PRE-STUDY TESTING (1-2 hours):

        1. Come to the Lab in the morning in an overnight fasted state.

        2. Complete orientation to the study, and provide voluntary consent to join the study.

        3. Complete a medical health questionnaire to verify medical history and lifestyle habits,
           and provide a 3-day food record.

        4. Record symptoms on a questionnaire regarding how subjects have felt for the previous
           four weeks using a 12-point Likert scale. Symptoms relate to digestive health, hunger,
           energy, infection, pain, allergies, stress, mental focus, and overall wellbeing.

        5. All forms reviewed to determine eligibility to participate in this study.

        6. Subject height, body weight, and percent body fat measured.

        7. A blood sample taken by a trained phlebotomist; the sample not to exceed 40 mL. Blood
           tested for markers associated with inflammation and cardiovascular health, and
           nutritional compounds related to drinking watermelon puree.

        8. Subjects randomized to the Control or Watermelon group. If assigned to the Watermelon
           group subjects provided a six-week supply of watermelon puree.

        9. The morning of the study subjects consume the three bottles of watermelon puree (710 mL
           total, Watermelon group) each day thereafter for six weeks or maintain normal daily
           fluid intake (Control group).

       10. Six weeks after beginning the study subjects return to the Laboratory for the final
           measurements. Subjects to bring all beverage bottles.

      6-WEEK LAB VISIT (1-2 hours):

        1. Participants come to the Lab in the morning in an overnight fasted state.

        2. Subject body weight, and percent body fat are measured.

        3. Subjects record symptoms on a questionnaire regarding how they have felt for the
           previous six weeks.

        4. A final blood sample (40 mL) taken by a trained phlebotomist.

      BLOOD SAMPLE ANALYSES

        1. Blood borne cardiovascular disease markers: ADAM metallopeptidase with thrombospondin
           type 1 motif, 13 (ADAMTS13), soluble vascular cell adhesion molecule-1 (sVCAM-1),
           soluble P-selectin (sP-selectin), growth differentiation factor-15 (GDF-15), and soluble
           intercellular adhesion molecule-1 (sICAM-1) measured according to the manufacturer's
           specifications using the MAGPIX instrument and xPONENT analysis software (Luminex,
           Austin, TX).

        2. Fasting blood glucose, insulin, vitamin C, and high-sensitivity C-reactive (hs-CRP)
           protein were measured by LabCorp (Burlington, NC).

        3. Fasting plasma carotenoid concentrations measured commercially (Craft Technologies Inc.,
           Wilson, NC).

        4. Fasting plasma amino acid concentration determined by high-performance liquid
           chromatography.
    

Intervention name(s): Watermelon
Intervention type(s): Dietary Supplement
Intervention description(s): Pureed whole (100%) watermelon
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: randomized
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: insulin; glucose; cardiovascular disease; inflammation; watermelon; L-citrulline; L-arginine