Acute Effects of Watermelon on Vascular Function and Serum Lycopene

Vascular Health of Postmenopausal Women Clinical Trial

Official title:

Acute Effects of Watermelon on Vascular Function and Serum Lycopene

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03608254
• Other study ID #: 15-07-95
• Status: Completed
• Start date: November 5, 2015
• Est. completion date: December 8, 2016

Study information

• Verified date: December 2021
• Source: University of Alabama, Tuscaloosa
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: December 8, 2016
• Est. primary completion date: December 8, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 65 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Vascular Health of Postmenopausal Women

Intervention

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.

Locations

Country	Name	City	State
United States	University of Alabama	Tuscaloosa	Alabama

Sponsors (1)

Lead Sponsor	Collaborator
University of Alabama, Tuscaloosa

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in Circulating Lycopene Levels	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.	2 hours post-ingestion
Secondary	Change From Baseline in Endothelial-dependent Vasodilation	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.	2 hours post-ingestion