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

NCT04015544 | Completed

• 1 other identifier: 14-0092
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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.

Conditions

Postmenopausal; Overweight and Obesity

Keywords

insulin; glucose; cardiovascular disease; inflammation; watermelon; L-citrulline; L-arginine

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Blood glucose

  Pre-study and study completion (6 weeks)

• Blood insulin

  Pre-study and study completion (6 weeks)

• Blood carotenoids

  Pre-study and study completion (6 weeks)

• Blood amino acids

  Pre-study and study completion (6 weeks)

• Body mass

  Pre-study and study completion (6 weeks)

Study Arms (2)

Watermelon

EXPERIMENTAL

Watermelon puree 710 mL per day for six weeks

Dietary Supplement: Watermelon

Control

NO INTERVENTION

No intervention

Interventions

Watermelon DIETARY_SUPPLEMENT

Pureed whole (100%) watermelon

Watermelon

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female
• 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).

You may not qualify if:

• 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).

Sponsors & Collaborators

• Appalachian State University: lead
• National Watermelon Promotion Board; https://www.watermelon.org: collaborator

Study Sites (1)

Appalachian State University

Boone, North Carolina, 28608, United States

Location

Related 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. doi: 10.1016/j.nut.2007.01.005.

  PMID: 17352962 BACKGROUND

• 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.

  PMID: 970770 BACKGROUND

• 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.

  PMID: 30870970 BACKGROUND

• 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.

  PMID: 12672916 BACKGROUND

• 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.

  PMID: 21050132 BACKGROUND

MeSH Terms

Conditions

Overweight; Obesity; Insulin Resistance; Cardiovascular Diseases; Inflammation

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Pathologic Processes

Study Officials

• R. Andrew Shanely, Ph.D.

  Appalachian State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: randomized

Study Record Dates

• First Submitted: July 2, 2019
• First Posted: July 11, 2019
• Study Start: April 1, 2014
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: July 11, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)