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PostmenopausalNCT04015544

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

A study testing Watermelon in people with Postmenopausal and Overweight and Obesity, run by Appalachian State University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 50 to 75 years, women onlyHealthy volunteers can take part
Conditions the study is for
Postmenopausal, Overweight and Obesity
What is being tested?
Watermelon
Could I receive a placebo?
No, everyone receives an active treatment
How many people
52 participants
Where
1 siteUnited States
Study dates
Apr 2014to Jul 2014
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 to 75 years
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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;
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  • 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).

Who cannot join

  • 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),
Show all 10Show fewer
  • 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).

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Appalachian State University

    Boone, North Carolina, 28608

Other trials in United States

About this study

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

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.

Read the 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.
Being tested
Watermelon
Keywords
insulin, glucose, cardiovascular disease, inflammation, watermelon, L-citrulline, L-arginine
Medical subject headings
Overweight, Obesity, Insulin Resistance, Cardiovascular Diseases, Inflammation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • WatermelonDietary supplement

    Pureed whole (100%) watermelon

Study groups in NCT04015544
Study groupRoleWhat they receive
WatermelonExperimentalWatermelon puree 710 mL per day for six weeks
Receives: Dietary Supplement: Watermelon
ControlNo interventionNo intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in select plasma cardiovascular disease markers

    Plasma concentrations of ADAMTS13, sVCAM-1, sP-selectin, GDF-15, hs-CRP, and sICAM-1

    Measured: Pre-study and study completion (6 weeks)

Secondary outcomes (6)

  1. Blood glucose

    Fasting blood glucose

    Measured: Pre-study and study completion (6 weeks)

  2. Blood insulin

    Fasting blood insulin

    Measured: Pre-study and study completion (6 weeks)

  3. Blood carotenoids

    Fasting blood carotenoids

    Measured: Pre-study and study completion (6 weeks)

  4. Blood amino acids

    Fasting blood amino acids

    Measured: Pre-study and study completion (6 weeks)

  5. Body mass

    Body mass (kg)

    Measured: Pre-study and study completion (6 weeks)

  6. Body mass index

    Body mass index (kg/m2)

    Measured: Pre-study and study completion (6 weeks)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jul 2019
  2. Study startApr 2014
  3. Primary completionJul 2014
  4. Study completionJul 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Parallel groups
Model description
randomized
Masking
None (open label)
Enrolment
52 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04015544
Sponsor's protocol ID
14-0092
Status last verified
Jul 2019
First submitted
2 Jul 2019
Last updated
11 Jul 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 17352962

  • 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.

    PubMed 970770

  • 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.

    PubMed 30870970

  • 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.

    PubMed 12672916

  • 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.

    PubMed 21050132

Questions about this trial

What is this clinical trial studying?

A study testing Watermelon in people with Postmenopausal and Overweight and Obesity, run by Appalachian State University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in select plasma cardiovascular disease markers (time frame: Pre-study and study completion (6 weeks)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04015544, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2019.

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