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Trial record 1 of 1 for:    NCT03608254
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Acute Effects of Watermelon on Vascular Function and Serum Lycopene

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ClinicalTrials.gov Identifier: NCT03608254
Recruitment Status : Completed
First Posted : July 31, 2018
Last Update Posted : August 3, 2018
Sponsor:
Information provided by (Responsible Party):
Amy Ellis, University of Alabama, Tuscaloosa

Brief Summary:
This study aimed to examine the effects of a one-time dose of 100% watermelon juice on circulating lycopene levels and measures of vascular health among a cohort of postmenopausal women.

Condition or disease Intervention/treatment
Vascular Health of Postmenopausal Women Other: 100% watermelon juice

Detailed Description:

Purpose and Objectives Arterial stiffness and endothelial dysfunction are early independent predictors of cardiovascular disease (CVD), the leading cause of death for women ages 60 and older in the United States. It is well-known that age-related decreases in vascular function are partially due to increases in oxidative stress and inflammation. In attempts to combat CVD, previous studies have investigated provision of isolated food compounds in supplement form. For example, purified lycopene has been shown to decrease oxidative stress, and our previous work supports the supplemental use of glutamine and arginine powders for improving vascular endothelial function of older adults. Watermelon is among the greatest plant sources of arginine and glutamine, and it is one of the richest sources of lycopene. However, clinical studies evaluating the whole food have not been done.

According to the Healthy Eating Index, only 27% of women ages 60 and older meet the daily dietary recommendations for 2.5 fruit servings. Likewise, although no Recommended Dietary Allowance for lycopene exists, this age group consumes less lycopene daily than is provided in one serving of watermelon. While reasons for poor fruit intake among older adults are multifactorial, difficulty chewing and inability to prepare fresh foods in the home environment have been noted as significant barriers to fresh fruit and vegetable intake. Of note, a previous systematic review suggests that 100% fruit and vegetable juices may be practical vehicles for improving intake of antioxidant nutrients among older adults. The provision of 100% watermelon juice to older adult women represents a practical, innovative approach to increase consumption of a food containing multiple components that may act in synergy to improve vascular function. Therefore, the purpose of this study is to investigate the effects of a one-time serving of 100% watermelon juice on blood vessel function and serum lycopene.

Specific Aims

The specific aims of this study are to:

  1. To determine whether consumption of a 12-ounce serving of 100% watermelon juice by non-obese women ages 60-75 will result in increased levels of serum lycopene.

    Hypotheses: Acute supplementation with 100% watermelon juice will result in increased serum lycopene.

  2. To determine whether consumption of a 12-ounce serving of 100% watermelon juice by non-obese women ages 60-75 will result in improved vascular endothelial function as assessed by flow-mediated dilation (FMD) and decreased arterial stiffness as assessed by pulse wave analysis (PWA).

Hypotheses: Acute supplementation with 100% watermelon juice will result in improved vascular endothelial function and decreased arterial stiffness.


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Study Type : Observational
Actual Enrollment : 11 participants
Observational Model: Other
Time Perspective: Cross-Sectional
Official Title: Acute Effects of Watermelon on Vascular Function and Serum Lycopene
Actual Study Start Date : November 5, 2015
Actual Primary Completion Date : December 8, 2016
Actual Study Completion Date : December 8, 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Lycopene


Intervention Details:
  • Other: 100% watermelon juice
    Participants consumed a one-time dose of 100% watermelon juice. Blood was sampled before and 2 hours after ingestion. Blood pressure and brachial artery flow-mediated dilation were measured before and 2 hours after ingestion.


Primary Outcome Measures :
  1. Circulating lycopene [ Time Frame: baseline to 2 hours post-ingestion ]
    Serum levels of lycopene


Secondary Outcome Measures :
  1. Endothelial-dependent vasodilation [ Time Frame: baseline to 2 hours post-ingestion ]
    Brachial artery flow-mediated dilation (FMD)


Biospecimen Retention:   Samples Without DNA
Banked serum will be stored at -80 degrees C.


Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years to 70 Years   (Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Community-dwelling postmenopausal women
Criteria

Inclusion Criteria:

  • Body mass index 18.5 - 29.9 kg/m2 (non-obese)
  • Ambulatory
  • Postmenopausal female
  • Ages 65-70 years

Exclusion Criteria:

  • Food allergy to watermelon
  • Diagnosis of phenylketonuria
  • History of hypotension, chronic uncontrolled hypertension, chronic kidney disease, diabetes, previous cardiac events or procedures,
  • Smoking or other tobacco use
  • Use of anticoagulant medications, cholesterol-lowering medications, vasodilatory dietary supplements (garlic, fish oil), or dietary supplements containing lycopene, ascorbic acid, L-glutamine, L-arginine, or L-citrulline
  • Weight change > 10% in the previous six months

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): NCT03608254


Locations
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United States, Alabama
University of Alabama
Tuscaloosa, Alabama, United States, 35487
Sponsors and Collaborators
University of Alabama, Tuscaloosa
Investigators
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Principal Investigator: Amy C Ellis, PhD, RD University of Alabama at Birmingham

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Amy Ellis, Assistant Professor, University of Alabama, Tuscaloosa
ClinicalTrials.gov Identifier: NCT03608254     History of Changes
Other Study ID Numbers: 15-07-95
First Posted: July 31, 2018    Key Record Dates
Last Update Posted: August 3, 2018
Last Verified: August 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Lycopene
Anti-Inflammatory Agents
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Radiation-Protective Agents
Anticarcinogenic Agents
Antineoplastic Agents