Acute Effects of Watermelon on Vascular Function and Serum Lycopene

• Sponsor: University of Alabama, Tuscaloosa (Other)
• Overall Status: Completed
• CT.gov ID: NCT03608254
• Collaborator: (none)
• Enrollment: 11
• Location: 1
• Actual Duration (Months): 13.1
• Patients Per Site Per Month: 0.8

Study Details

Study Description

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	Phase
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.

1. 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.

Study Design

• 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: Nov 5, 2015
• Actual Primary Completion Date: Dec 8, 2016
• Actual Study Completion Date: Dec 8, 2016

Outcome Measures

Primary Outcome Measures

1. Change From Baseline in Circulating Lycopene Levels [2 hours post-ingestion]

   On the testing day, participants reported to the clinic following a 10-hour overnight fast. Blood samples were obtained by standard venipuncture at baseline and two hours after ingestion of a 360 ml dose of 100% pasteurized watermelon juice in order to determine change in serum lycopene levels.

Secondary Outcome Measures

1. Change From Baseline in Endothelial-dependent Vasodilation [2 hours post-ingestion]

   Brachial artery flow-mediated dilation (FMD) was used to assess endothelial-dependent vasodilation. 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. FMD measurements were taken at baseline and 2 hours after ingestion of the 100% watermelon juice. The outcome measure reflects change in FMD from baseline to 2 hours post-ingestion.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 65 Years to 70 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Alabama	Tuscaloosa	Alabama	United States	35487

Sponsors and Collaborators

• University of Alabama, Tuscaloosa

Investigators

• Principal Investigator: Amy C Ellis, PhD, RD, University of Alabama at Birmingham

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Amy Ellis, Assistant Professor, University of Alabama, Tuscaloosa
• ClinicalTrials.gov Identifier: NCT03608254
• Other Study ID Numbers: 15-07-95
• First Posted: Jul 31, 2018
• Last Update Posted: Mar 14, 2022
• Last Verified: Dec 1, 2021

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

Study Results

Participant Flow

Arm/Group Title	Watermelon Juice
Arm/Group Description	All participants consumed 12 ounces of 100% watermelon juice. Blood samples were taken, and flow-mediated dilation was measured before consumption of the juice and two hours afterward.
Period Title: Overall Study
STARTED	11
COMPLETED	8
NOT COMPLETED	3

Baseline Characteristics

Arm/Group Title	Watermelon Juice
Arm/Group Description	All participants consumed 12 ounces of 100% watermelon juice. Blood samples were taken, and flow-mediated dilation was measured before consumption of the juice and two hours afterward.
Overall Participants	11
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	2 18.2%
>=65 years	9 81.8%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	65.73 (2.28)
Sex: Female, Male (Count of Participants)
Female	11 100%
Male	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	0 0%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	4 36.4%
White	7 63.6%
More than one race	0 0%
Unknown or Not Reported	0 0%
Region of Enrollment (Count of Participants)
United States	11 100%
Serum lycopene (umol/L) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [umol/L]	1.48 (1.07)
Flow-mediated dilation (FMD) (percent change in diameter) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [percent change in diameter]	9.93 (6.09)

Outcome Measures

1. Primary Outcome

Title	Change From Baseline in Circulating Lycopene Levels
Description	On the testing day, participants reported to the clinic following a 10-hour overnight fast. Blood samples were obtained by standard venipuncture at baseline and two hours after ingestion of a 360 ml dose of 100% pasteurized watermelon juice in order to determine change in serum lycopene levels.
Time Frame	2 hours post-ingestion

Outcome Measure Data

Analysis Population Description

Eleven participants provided consent for the cross-sectional study. Blood sampling was not possible for two participants, and one participant did not consume the entire 12-ounce dose of juice.

Arm/Group Title	Watermelon Juice
Arm/Group Description	Participants consumed 12 ounces of 100% watermelon juice. Blood samples were taken, and flow-mediated dilation was measured before consumption of the juice and two hours afterward.
Measure Participants	8
Mean (Standard Deviation) [umol/L]	2.85 (0.66)

2. Secondary Outcome

Title	Change From Baseline in Endothelial-dependent Vasodilation
Description	Brachial artery flow-mediated dilation (FMD) was used to assess endothelial-dependent vasodilation. 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. FMD measurements were taken at baseline and 2 hours after ingestion of the 100% watermelon juice. The outcome measure reflects change in FMD from baseline to 2 hours post-ingestion.
Time Frame	2 hours post-ingestion

Outcome Measure Data

Analysis Population Description

One participant did not consume the entire 12-ounce dose of juice.

Arm/Group Title	Watermelon Juice
Arm/Group Description	Participants consumed 12 ounces of 100% watermelon juice. Blood samples were taken, and flow-mediated dilation was measured before consumption of the juice and two hours afterward.
Measure Participants	10
Mean (Standard Deviation) [percent change from baseline]	2.33 (7.33)

Adverse Events

Time Frame	Participants were monitored for adverse events the day they participated in the study.
Arm/Group Title	Watermelon Juice
Arm/Group Description	All participants consumed 12 ounces of 100% watermelon juice. Blood samples were taken, and flow-mediated dilation was measured before consumption of the juice and two hours afterward.
All Cause Mortality
	Watermelon Juice
	Affected / at Risk (%)	# Events
Total	0/11 (0%)
Serious Adverse Events
	Watermelon Juice
	Affected / at Risk (%)	# Events
Total	0/11 (0%)
Other (Not Including Serious) Adverse Events
	Watermelon Juice
	Affected / at Risk (%)	# Events
Total	0/11 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.