Markers of Atherosclerosis in Overweight, Postmenopausal Women Following Daily Watermelon Consumption

Overweight and Obesity Clinical Trial

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

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Atherosclerosis
• Overweight
• Overweight and Obesity
• Postmenopausal

• NCT number: NCT04015544
• Study type: Interventional
• Source: Appalachian State University
• Status: Completed
• Phase: N/A
• Start date: April 2014
• Completion date: July 2014