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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04015544
• Other study ID #: 14-0092
• Status: Completed
• Phase: N/A
• Start date: April 2014
• Est. completion date: July 2014

Study information

• Verified date: July 2019
• Source: Appalachian State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 50 Years to 75 Years

Eligibility

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).

Related Conditions & MeSH terms

• Atherosclerosis
• Overweight
• Overweight and Obesity
• Postmenopausal

Intervention

Dietary Supplement:
• Watermelon
Pureed whole (100%) watermelon

Locations

Country	Name	City	State
United States	Appalachian State University	Boone	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Appalachian State University	National Watermelon Promotion Board; https://www.watermelon.org

Country where clinical trial is conducted

United States, 

References & Publications (5)

Collins JK, Wu G, Perkins-Veazie P, Spears K, Claypool PL, Baker RA, Clevidence BA. Watermelon consumption increases plasma arginine concentrations in adults. Nutrition. 2007 Mar;23(3):261-6. — View Citation

Cook-Mills JM, Marchese ME, Abdala-Valencia H. Vascular cell adhesion molecule-1 expression and signaling during disease: regulation by reactive oxygen species and antioxidants. Antioxid Redox Signal. 2011 Sep 15;15(6):1607-38. doi: 10.1089/ars.2010.3522. Epub 2011 May 11. Review. — View Citation

Edwards AJ, Vinyard BT, Wiley ER, Brown ED, Collins JK, Perkins-Veazie P, Baker RA, Clevidence BA. Consumption of watermelon juice increases plasma concentrations of lycopene and beta-carotene in humans. J Nutr. 2003 Apr;133(4):1043-50. — View Citation

Kannel WB, Hjortland MC, McNamara PM, Gordon T. Menopause and risk of cardiovascular disease: the Framingham study. Ann Intern Med. 1976 Oct;85(4):447-52. — View Citation

Lum T, Connolly M, Marx A, Beidler J, Hooshmand S, Kern M, Liu C, Hong MY. Effects of Fresh Watermelon Consumption on the Acute Satiety Response and Cardiometabolic Risk Factors in Overweight and Obese Adults. Nutrients. 2019 Mar 12;11(3). pii: E595. doi: 10.3390/nu11030595. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Blood glucose	Fasting blood glucose	Pre-study and study completion (6 weeks)
Secondary	Blood insulin	Fasting blood insulin	Pre-study and study completion (6 weeks)
Secondary	Blood carotenoids	Fasting blood carotenoids	Pre-study and study completion (6 weeks)
Secondary	Blood amino acids	Fasting blood amino acids	Pre-study and study completion (6 weeks)
Secondary	Body mass	Body mass (kg)	Pre-study and study completion (6 weeks)
Secondary	Body mass index	Body mass index (kg/m2)	Pre-study and study completion (6 weeks)