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

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ClinicalTrials.gov Identifier: NCT04015544
Recruitment Status : Completed
First Posted : July 11, 2019
Last Update Posted : July 11, 2019
Sponsor:
Collaborator:
National Watermelon Promotion Board; https://www.watermelon.org
Information provided by (Responsible Party):
Appalachian State University

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.

Condition or disease Intervention/treatment Phase
Postmenopausal Overweight and Obesity Dietary Supplement: Watermelon Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 52 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: randomized
Masking: None (Open Label)
Primary Purpose: Basic Science
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
Actual Study Start Date : April 2014
Actual Primary Completion Date : July 2014
Actual Study Completion Date : July 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Atherosclerosis

Arm Intervention/treatment
Experimental: Watermelon
Watermelon puree 710 mL per day for six weeks
Dietary Supplement: Watermelon
Pureed whole (100%) watermelon

No Intervention: Control
No intervention



Primary Outcome Measures :
  1. Change in select plasma cardiovascular disease markers [ Time Frame: Pre-study and study completion (6 weeks) ]
    Plasma concentrations of ADAMTS13, sVCAM-1, sP-selectin, GDF-15, hs-CRP, and sICAM-1


Secondary Outcome Measures :
  1. Blood glucose [ Time Frame: Pre-study and study completion (6 weeks) ]
    Fasting blood glucose

  2. Blood insulin [ Time Frame: Pre-study and study completion (6 weeks) ]
    Fasting blood insulin

  3. Blood carotenoids [ Time Frame: Pre-study and study completion (6 weeks) ]
    Fasting blood carotenoids

  4. Blood amino acids [ Time Frame: Pre-study and study completion (6 weeks) ]
    Fasting blood amino acids

  5. Body mass [ Time Frame: Pre-study and study completion (6 weeks) ]
    Body mass (kg)

  6. Body mass index [ Time Frame: Pre-study and study completion (6 weeks) ]
    Body mass index (kg/m2)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   50 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04015544


Locations
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United States, North Carolina
Appalachian State University
Boone, North Carolina, United States, 28608
Sponsors and Collaborators
Appalachian State University
National Watermelon Promotion Board; https://www.watermelon.org
Investigators
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Principal Investigator: R. Andrew Shanely, Ph.D. Appalachian State University

Publications:
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Responsible Party: Appalachian State University
ClinicalTrials.gov Identifier: NCT04015544     History of Changes
Other Study ID Numbers: 14-0092
First Posted: July 11, 2019    Key Record Dates
Last Update Posted: July 11, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Appalachian State University:
insulin
glucose
cardiovascular disease
inflammation
watermelon
L-citrulline
L-arginine
Additional relevant MeSH terms:
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Atherosclerosis
Overweight
Body Weight
Signs and Symptoms
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases