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Clinical Trials/NCT03608254
NCT03608254CompletedNot Applicable

Acute Effects of Watermelon on Vascular Function and Serum Lycopene

University of Alabama, Tuscaloosa1 site in 1 country11 target enrollmentStarted: November 5, 2015Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
11
Locations
1
Primary Endpoint
Change From Baseline in Circulating Lycopene Levels

Study Overview

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.

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.

Study Design

Study Type
Observational
Observational Model
Other
Time Perspective
Cross Sectional

Eligibility Criteria

Ages
65 Years to 70 Years (Older Adult)
Sex
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

Outcomes

Primary Outcomes

Change From Baseline in Circulating Lycopene Levels

Time Frame: 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 Outcomes

  • Change From Baseline in Endothelial-dependent Vasodilation(2 hours post-ingestion)

Investigators

Sponsor
University of Alabama, Tuscaloosa
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Amy Ellis

Assistant Professor

University of Alabama, Tuscaloosa

Study Sites (1)

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