Vascular Health of Postmenopausal WomenNCT03608254
Acute Effects of Watermelon on Vascular Function and Serum Lycopene
An observational study of Vascular Health of Postmenopausal Women, run by University of Alabama, Tuscaloosa at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 65 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Vascular Health of Postmenopausal Women
- What is being tested?
- 100% watermelon juice
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Nov 2015to 8 Dec 2016
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 70 years
- Women only
- Healthy volunteers accepted
- Older adult
Study population: Community-dwelling postmenopausal women
Who may be able to join
- Body mass index 18.5 - 29.9 kg/m2 (non-obese)
- Ambulatory
- Postmenopausal female
- Ages 65-70 years
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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:
- 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.
- 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.
- Conditions
- Vascular Health of Postmenopausal Women
- Being tested
- 100% watermelon juice
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
100% watermelon juiceOther
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 hours post-ingestion
Secondary outcomes (1)
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.
Measured: 2 hours post-ingestion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2018
- Study start5 Nov 2015
- Primary completion8 Dec 2016
- Study completion8 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Vascular Health of Postmenopausal WomenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama, Tuscaloosa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amy Ellis, University of Alabama, Tuscaloosa
- Investigators
- Amy C Ellis, PhD, RD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03608254
- Sponsor's protocol ID
- 15-07-95
- Status last verified
- Dec 2021
- First submitted
- 24 Jul 2018
- Last updated
- 14 Mar 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ellis AC, Dudenbostel T, Crowe-White K. Watermelon Juice: a Novel Functional Food to Increase Circulating Lycopene in Older Adult Women. Plant Foods Hum Nutr. 2019 Jun;74(2):200-203. doi: 10.1007/s11130-019-00719-9.
PubMed 30756297
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Effects of Watermelon on Vascular Function and Serum Lycopene
- ClinicalTrials.gov ID
- NCT03608254
- Acronym / sponsor ID
- 15-07-95
- Conditions
- Vascular Health of Postmenopausal Women
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- University of Alabama, TuscaloosaUniversity, hospital or other
- Study start
- 5 Nov 2015 (actual)
- Primary completion
- 8 Dec 2016 (actual)
- Study completion
- 8 Dec 2016 (actual)
- First posted
- 31 Jul 2018 (actual)
- Results
- Posted 14 Mar 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- 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
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 65 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- Community-dwelling postmenopausal women
Key inclusion criteria (4 listed)
- Body mass index 18.5 - 29.9 kg/m2 (non-obese)
- Ambulatory
- Postmenopausal female
- Ages 65-70 years
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 100% watermelon juiceParticipants 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. | Other | – |
Primary outcome
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.
1 secondary outcome
Change From Baseline in Endothelial-dependent Vasodilation
Time frame: 2 hours post-ingestion
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 30756297Ellis AC, Dudenbostel T, Crowe-White K. Watermelon Juice: a Novel Functional Food to Increase Circulating Lycopene in Older Adult Women. Plant Foods Hum Nutr. 2019 Jun;74(2):200-203. doi: 10.1007/s11130-019-00719-9.
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Nitrate, Exercise and Vascular Function in Midlife Women
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amy C Ellis, PhD, RD principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vascular Health of Postmenopausal Women, run by University of Alabama, Tuscaloosa at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Mar 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Circulating Lycopene Levels (time frame: 2 hours post-ingestion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03608254, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2022.