Markers of Atherosclerosis in Overweight, Postmenopausal Women Following Daily Watermelon Consumption
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|ClinicalTrials.gov Identifier: NCT04015544|
Recruitment Status : Completed
First Posted : July 11, 2019
Last Update Posted : July 11, 2019
|Condition or disease||Intervention/treatment||Phase|
|Postmenopausal Overweight and Obesity||Dietary Supplement: Watermelon||Not Applicable|
ORIENTATION AND PRE-STUDY TESTING (1-2 hours):
- Come to the Lab in the morning in an overnight fasted state.
- Complete orientation to the study, and provide voluntary consent to join the study.
- Complete a medical health questionnaire to verify medical history and lifestyle habits, and provide a 3-day food record.
- 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.
- All forms reviewed to determine eligibility to participate in this study.
- Subject height, body weight, and percent body fat measured.
- 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.
- Subjects randomized to the Control or Watermelon group. If assigned to the Watermelon group subjects provided a six-week supply of watermelon puree.
- 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).
- 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):
- Participants come to the Lab in the morning in an overnight fasted state.
- Subject body weight, and percent body fat are measured.
- Subjects record symptoms on a questionnaire regarding how they have felt for the previous six weeks.
- A final blood sample (40 mL) taken by a trained phlebotomist.
BLOOD SAMPLE ANALYSES
- 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).
- Fasting blood glucose, insulin, vitamin C, and high-sensitivity C-reactive (hs-CRP) protein were measured by LabCorp (Burlington, NC).
- Fasting plasma carotenoid concentrations measured commercially (Craft Technologies Inc., Wilson, NC).
- Fasting plasma amino acid concentration determined by high-performance liquid chromatography.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||52 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||randomized|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||Expression of Systemic Markers of Atherosclerosis in Free-living, Overweight, Postmenopausal Women Following Daily Watermelon Consumption for Six Weeks: A Randomized Controlled Trial|
|Actual Study Start Date :||April 2014|
|Actual Primary Completion Date :||July 2014|
|Actual Study Completion Date :||July 2014|
Watermelon puree 710 mL per day for six weeks
Dietary Supplement: Watermelon
Pureed whole (100%) watermelon
No Intervention: Control
- Change in select plasma cardiovascular disease markers [ Time Frame: Pre-study and study completion (6 weeks) ]Plasma concentrations of ADAMTS13, sVCAM-1, sP-selectin, GDF-15, hs-CRP, and sICAM-1
- Blood glucose [ Time Frame: Pre-study and study completion (6 weeks) ]Fasting blood glucose
- Blood insulin [ Time Frame: Pre-study and study completion (6 weeks) ]Fasting blood insulin
- Blood carotenoids [ Time Frame: Pre-study and study completion (6 weeks) ]Fasting blood carotenoids
- Blood amino acids [ Time Frame: Pre-study and study completion (6 weeks) ]Fasting blood amino acids
- Body mass [ Time Frame: Pre-study and study completion (6 weeks) ]Body mass (kg)
- Body mass index [ Time Frame: Pre-study and study completion (6 weeks) ]Body mass index (kg/m2)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04015544
|United States, North Carolina|
|Appalachian State University|
|Boone, North Carolina, United States, 28608|
|Principal Investigator:||R. Andrew Shanely, Ph.D.||Appalachian State University|