Bioactive Compounds in Watermelon Modulating Oxidative Stress and Inflammation in Elders

NCT03626168 | Completed Results

• 1 other identifier: 16MCPRP27260233
• Study Type: interventional
• Target: 21
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Arterial Stiffness; Inflammation

Outcome Measures

Primary Outcomes (3)

• Change From Baseline in Serum Levels of Lycopene at 4 Weeks

  Lycopene determined by ultra high performance liquid chromatography with photodiode array detector (UPLC-PDA).

  Baseline and 4 Weeks

• Change in Vascular Endothelial Function at 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.

  Baseline and 4 weeks

• Change in Arterial Stiffness at 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.

  Baseline and 4 weeks

Study Arms (2)

Consumption of 100% watermelon juice

ACTIVE COMPARATOR

Consumption of two 12-ounce doses of pasteurized 100% watermelon juice for a four-week period

Dietary Supplement: 100% watermelon juice

Consumption of a placebo beverage

PLACEBO COMPARATOR

Consumption of a placebo beverage with comparable sugar content, pH, taste, texture, and color for a four-week period

Other: Placebo beverage

Interventions

100% watermelon juice DIETARY_SUPPLEMENT

Participants drank two 12-ounce servings of 100% watermelon juice per day for a four-week period.

Consumption of 100% watermelon juice

Placebo beverage OTHER

Participants drank two 12-ounce servings of a placebo beverage per day for a four-week period.

Consumption of a placebo beverage

Eligibility Criteria

• Age: 55 Years - 69 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Alabama, Tuscaloosa: lead

Related Publications (3)

• Ellis AC, Dudenbostel T, Locher JL, Crowe-White K. Modulating Oxidative Stress and Inflammation in Elders: The MOXIE Study. J Nutr Gerontol Geriatr. 2016 Oct-Dec;35(4):219-242. doi: 10.1080/21551197.2016.1250693.

  PMID: 27897608 BACKGROUND

• Ellis AC, Mehta T, Nagabooshanam VA, Dudenbostel T, Locher JL, Crowe-White KM. Daily 100% watermelon juice consumption and vascular function among postmenopausal women: A randomized controlled trial. Nutr Metab Cardiovasc Dis. 2021 Sep 22;31(10):2959-2968. doi: 10.1016/j.numecd.2021.06.022. Epub 2021 Jul 7.

  PMID: 34344546 DERIVED

• Crowe-White KM, Voruganti VS, Talevi V, Dudenbostel T, Nagabooshanam VA, Locher JL, Ellis AC. Variation of Serum Lycopene in Response to 100% Watermelon Juice: An Exploratory Analysis of Genetic Variants in a Randomized Controlled Crossover Study. Curr Dev Nutr. 2020 Jun 17;4(7):nzaa102. doi: 10.1093/cdn/nzaa102. eCollection 2020 Jul.

  PMID: 32695957 DERIVED

MeSH Terms

Conditions

Inflammation

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr. Amy Ellis, principal investigator
• Organization: The University of Alabama

aellis@ches.ua.edu

205-348-8128

Study Officials

• Amy C Ellis, PhD, RD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

• Kristi Crowe-White, PhD, RD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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.

Study Record Dates

• First Submitted: July 24, 2018
• First Posted: August 10, 2018
• Study Start: February 16, 2016
• Primary Completion: May 12, 2018
• Study Completion: May 12, 2018
• Last Updated: May 17, 2022
• Results First Posted: May 17, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share