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Bioactive Compounds in Watermelon Modulating Oxidative Stress and Inflammation in Elders (MOXIE)

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ClinicalTrials.gov Identifier: NCT03626168
Recruitment Status : Completed
First Posted : August 10, 2018
Results First Posted : May 17, 2022
Last Update Posted : May 17, 2022
Sponsor:
Information provided by (Responsible Party):
Amy Ellis, University of Alabama, Tuscaloosa

Study Description
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Brief Summary:
Watermelon is the only food with a unique combination of amino acids and antioxidants that may reduce artery stiffness. However, only 27% of older adults meet the daily recommendation for fruit intake. Because it tastes good and is convenient and easy to consume, watermelon juice is an innovative and impactful intervention to help elders easily meet recommendations for fruit servings. If effective, this intervention would be a simple, inexpensive way to combat cardiovascular diseases (CVD). Results will advance science by providing a better understanding whether four-week consumption of 100% watermelon juice may impact measures of vascular health and inflammation in postmenopausal women.

Condition or disease Intervention/treatment Phase
Arterial Stiffness Inflammation Dietary Supplement: 100% watermelon juice Other: Placebo beverage Not Applicable

Detailed Description:

Purpose and Objectives:

Vascular endothelial dysfunction is an early independent predictor of cardiovascular diseases (CVD), the leading cause of death for women ages 60 and older in the United States1. It is well-known that age-related decreases in vascular endothelial function are partially due to increases in oxidative stress and inflammation.In attempts to combat CVD, previous intervention studies have investigated provision of isolated bioactive food compounds (BFC) in supplemental form. For example, purified lycopene has been shown to decrease oxidative stress, and our previous work supports the supplemental use of glutamine and arginine in improving vascular endothelial function of older adults. Arginine is a precursor for the vasodilatory molecule nitric oxide (NO), and both glutamine and arginine have been shown to attenuate inflammation. Thus, if supplemented together, these compounds would be expected to exert synergist mechanistic effects that improve vascular function.

Watermelon is one of the richest sources of lycopene, and it is among the greatest plant sources of arginine and glutamine. Watermelon also provides high amounts of citrulline (a precursor of arginine) along with the antioxidant ascorbic acid, which enhances the antioxidant and anti-inflammatory effects of carotenoids such as lycopene in biological samples. To date, clinical studies evaluating the potential synergy of these compounds provided by the whole food are lacking on mechanistic and clinical outcomes of CVD. The effects of watermelon supplementation on robust measures of vascular function, inflammation, and oxidative stress in women ages 60 and older are unknown. This study will evaluate the possible impact of multiple bioactive compounds in the natural food matrix of watermelon in order to fully characterize their potential synergy and their influence on CVD risk. Specifically, our proposed study seeks to evaluate the influence of bioactive compounds in 100% watermelon juice, a convenient serving alternative to fresh fruit, using a randomized, double-blind placebo-controlled trial with a crossover design.

Specific Aims:

  1. Mechanistic: To determine whether community-dwelling, non-obese women ages 55-69 consuming two 12-ounce servings of 100% watermelon juice per day versus placebo for four weeks will demonstrate:

    1. increases in circulating levels of serum lycopene, citrulline, and arginine using ultra high performance liquid chromatography with photodiode array detector (UPLC-PDA).
    2. improvement in antioxidant status as assessed by the oxygen radical absorbance capacity assay (ORAC) of whole and deproteinated serum
    3. decreases in circulating biomarkers of inflammation Hypotheses: Four-week dietary supplementation with 100% watermelon juice will result in increased antioxidant capacity and decreased inflammation, related to increased serum lycopene, citrulline, and arginine

  2. Clinical: To determine whether community-dwelling, women ages 55-69 consuming two 12-ounce servings of 100% watermelon juice per day versus placebo for four weeks will exhibit:

    1. improved vascular endothelial function as assessed by flow-mediated dilation (FMD) and decreased arterial stiffness as assessed by pulse wave analysis (PWA)
    2. decreased low density lipoprotein (LDL) oxidation as assessed by enzyme immunoassay Hypotheses: Four-week dietary supplementation with 100% watermelon juice will result in improved vascular endothelial function, decreased arterial stiffness, and decreased LDL oxidation.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: In a double-blind crossover design, women ages 55-69 years were randomized to two 12-ounce servings of 100% watermelon juice per day or an isocaloric placebo for four weeks each with a 2-week washout period in between.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description: In this crossover design, the participants principal investigators, and outcomes assessors were blinded as to which treatment (100% watermelon juice or placebo) was consumed at each time.
Primary Purpose: Prevention
Official Title: Bioactive Compounds in Watermelon Modulating Oxidative Stress and Inflammation in Elders: The MOXIE Study
Actual Study Start Date : February 16, 2016
Actual Primary Completion Date : May 12, 2018
Actual Study Completion Date : May 12, 2018
Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Consumption of 100% watermelon juice
Consumption of two 12-ounce doses of pasteurized 100% watermelon juice for a four-week period
 Dietary Supplement: 100% watermelon juice
Participants drank two 12-ounce servings of 100% watermelon juice per day for a four-week period.
Placebo Comparator: Consumption of a placebo beverage
Consumption of a placebo beverage with comparable sugar content, pH, taste, texture, and color for a four-week period
 Other: Placebo beverage
Participants drank two 12-ounce servings of a placebo beverage per day for a four-week period.


Outcome Measures
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Primary Outcome Measures :
  1. Change From Baseline in Serum Levels of Lycopene at 4 Weeks [ Time Frame: Baseline and 4 Weeks ]
    Lycopene determined by ultra high performance liquid chromatography with photodiode array detector (UPLC-PDA).

  2. Change in Vascular Endothelial Function at 4 Weeks [ Time Frame: Baseline and 4 weeks ]
    Determined by brachial artery flow-mediated dilation (FMD). FMD uses ultrasound technology to quantify changes in brachial artery diameter in response to hyperemia. A blood pressure cuff was placed distal to the brachial artery of the right arm with the participant supine and rested. Pre-inflation diameter was recorded for one minute, and the cuff was inflated to 50 mmHg above resting SBP for five minutes. Then, images were recorded for 120 seconds after cuff deflation. Peak diameter was determined as an average of the five highest measurements over five seconds post-deflation. FMD was expressed as the percentage increase in peak diameter.

  3. Change in Arterial Stiffness at 4 Weeks [ Time Frame: Baseline and 4 weeks ]
    Determined by pulse wave velocity (PWV). A cuff-based system was used to measure brachial oscillometric pressure waveforms and generate central pressure curves by propriety algorithms. PWV was quantified as the rate at which a pulse wave moves down a vessel.


Eligibility Criteria
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Ages Eligible for Study:   55 Years to 69 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Ambulatory
  • Female
  • Age 55-69 years
  • Body mass index 18.5 - 29.9 kg/m2 (non-obese)

Exclusion Criteria:

  • Food allergy to watermelon
  • History of hypotension, chronic hypertension, chronic kidney disease, diabetes, previous cardiac events or procedures, phenylketonuria
  • Smoking or other tobacco use
  • Use of anticoagulant medications, cholesterol-lowering medications, blood-pressure 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 year
Contacts and Locations
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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): NCT03626168


Sponsors and Collaborators
University of Alabama, Tuscaloosa
Investigators
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Principal Investigator: Amy C Ellis, PhD, RD University of Alabama at Birmingham
Principal Investigator: Kristi Crowe-White, PhD, RD University of Alabama at Birmingham
  Study Documents (Full-Text)

Documents provided by Amy Ellis, University of Alabama, Tuscaloosa:
Study Protocol and Statistical Analysis Plan  [PDF] February 16, 2016
Informed Consent Form  [PDF] October 12, 2018

More Information
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Publications:

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: NCT03626168    
Other Study ID Numbers: 16MCPRP27260233
First Posted: August 10, 2018    Key Record Dates
Results First Posted: May 17, 2022
Last Update Posted: May 17, 2022
Last Verified: May 2022
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
Additional relevant MeSH terms:
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Inflammation
Pathologic Processes