Clinical trial NCT04015544: Markers of Atherosclerosis in Overweight, Postmenopausal Women Following Daily Watermelon Consumption
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postmenopausal
Overweight and Obesity
Keywords: insulin
glucose
cardiovascular disease
inflammation
watermelon
L-citrulline
L-arginine
Lead sponsor: Appalachian State University
Sponsor class: OTHER
Collaborators: name: National Watermelon Promotion Board; https://www.watermelon.org
First posted: 2019-07-11
Enrollment: 52
Sex: FEMALE
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized
Primary purpose: BASIC_SCIENCE

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):

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.

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).

Primary outcomes:
measure: Change in select plasma cardiovascular disease markers
timeFrame: Pre-study and study completion (6 weeks)
Secondary outcomes:
measure: Blood glucose
timeFrame: Pre-study and study completion (6 weeks)
measure: Blood insulin
timeFrame: Pre-study and study completion (6 weeks)
measure: Blood carotenoids
timeFrame: Pre-study and study completion (6 weeks)
measure: Blood amino acids
timeFrame: Pre-study and study completion (6 weeks)
measure: Body mass
timeFrame: Pre-study and study completion (6 weeks)
measure: Body mass index
timeFrame: Pre-study and study completion (6 weeks)
Other outcomes:
Locations:
city: Boone
country: United States
facility: Appalachian State University
state: North Carolina
Study officials:
affiliation: Appalachian State University
name: R. Andrew Shanely, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. doi: 10.1016/j.nut.2007.01.005.
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. doi: 10.7326/0003-4819-85-4-447.
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):595. doi: 10.3390/nu11030595.
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. doi: 10.1093/jn/133.4.1043.
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.