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

Study Overview
=================
Brief 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): 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.

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

Conditions
-----------------
Postmenopausal, Overweight and Obesity

Intervention / Treatment
-----------------
* Dietary Supplement: Watermelon


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female 50 to 75 years of age, have not menstruated for at least 1 year (menopause), have a BMI of ≥25 kg/m2, nonsmoker with no diagnosed history of chronic diseases including: coronary heart disease, stroke, cancer, type 1 or 2 diabetes mellitus, or rheumatoid arthritis; may not regularly consume large quantities of L-citrulline/L-arginine rich foods (red meat, tuna fish, cheese, nuts), may not regularly take L-citrulline/L-arginine supplements, may not use anti-hypertension medications (including diuretic medications), may not use exogenous ovarian hormones, or may not use medications known to influence inflammation within the two weeks of the study period (specifically non-steroidal anti-inflammatory drugs; NSAIDS). Exclusion Criteria: Male, younger than 50 or older than 75 years of age, menstruated within the last year, have a BMI of <25 kg/m2, smoker, diagnosed history of chronic diseases including: coronary heart disease, stroke, cancer, type 1 or 2 diabetes mellitus, or rheumatoid arthritis; regularly consume large quantities of L-citrulline/L-arginine rich foods (red meat, tuna fish, cheese, nuts), regularly take L-citrulline/L-arginine supplements, use anti-hypertension medications (including diuretic medications), use exogenous ovarian hormones, or use medications known to influence inflammation within the two weeks of the study period (specifically non-steroidal anti-inflammatory drugs; NSAIDS).

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: randomized
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Watermelon<br>Watermelon puree 710 mL per day for six weeks | Dietary Supplement: Watermelon<br>* Pureed whole (100%) watermelon<br>|
| No Intervention: Control<br>No intervention | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in select plasma cardiovascular disease markers | Plasma concentrations of ADAMTS13, sVCAM-1, sP-selectin, GDF-15, hs-CRP, and sICAM-1 | Pre-study and study completion (6 weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood glucose | Fasting blood glucose | Pre-study and study completion (6 weeks) | 
| Blood insulin | Fasting blood insulin | Pre-study and study completion (6 weeks) | 
| Blood carotenoids | Fasting blood carotenoids | Pre-study and study completion (6 weeks) | 
| Blood amino acids | Fasting blood amino acids | Pre-study and study completion (6 weeks) | 
| Body mass | Body mass (kg) | Pre-study and study completion (6 weeks) | 
| Body mass index | Body mass index (kg/m2) | Pre-study and study completion (6 weeks) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
insulin, glucose, cardiovascular disease, inflammation, watermelon, L-citrulline, L-arginine