Arterial StiffnessMOXIENCT03626168
Bioactive Compounds in Watermelon Modulating Oxidative Stress and Inflammation in Elders
A study testing 100% watermelon juice in people with Arterial Stiffness and Inflammation, run by University of Alabama, Tuscaloosa.
Trial 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. Read more about this study
- Who is it for?
- Ages 55 to 69 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Arterial Stiffness, Inflammation
- What is being tested?
- 100% watermelon juice
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 21 participants
- Where
- No sites listed yet
- Study dates
- 16 Feb 2016to 12 May 2018
- Phase
- Interventional
- 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 55 to 69 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Ambulatory
- Female
- Age 55-69 years
- Body mass index 18.5 - 29.9 kg/m2 (non-obese)
Who cannot join
- 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
About this study
Official title: Bioactive Compounds in Watermelon Modulating Oxidative Stress and Inflammation in Elders: The MOXIE Study
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.
Read the detailed description
Purpose and Objectives:
Vascular endothelial dysfunction is an early independent predictor of cardiovascular diseases (CVD), the leading cause of death for women ages 60 and older in the United States1. It is well-known that age-related decreases in vascular endothelial function are partially due to increases in oxidative stress and inflammation.In attempts to combat CVD, previous intervention studies have investigated provision of isolated bioactive food compounds (BFC) in supplemental form. For example, purified lycopene has been shown to decrease oxidative stress, and our previous work supports the supplemental use of glutamine and arginine in improving vascular endothelial function of older adults. Arginine is a precursor for the vasodilatory molecule nitric oxide (NO), and both glutamine and arginine have been shown to attenuate inflammation. Thus, if supplemented together, these compounds would be expected to exert synergist mechanistic effects that improve vascular function.
Watermelon is one of the richest sources of lycopene, and it is among the greatest plant sources of arginine and glutamine. Watermelon also provides high amounts of citrulline (a precursor of arginine) along with the antioxidant ascorbic acid, which enhances the antioxidant and anti-inflammatory effects of carotenoids such as lycopene in biological samples. To date, clinical studies evaluating the potential synergy of these compounds provided by the whole food are lacking on mechanistic and clinical outcomes of CVD. The effects of watermelon supplementation on robust measures of vascular function, inflammation, and oxidative stress in women ages 60 and older are unknown. This study will evaluate the possible impact of multiple bioactive compounds in the natural food matrix of watermelon in order to fully characterize their potential synergy and their influence on CVD risk. Specifically, our proposed study seeks to evaluate the influence of bioactive compounds in 100% watermelon juice, a convenient serving alternative to fresh fruit, using a randomized, double-blind placebo-controlled trial with a crossover design.
Specific Aims:
- Mechanistic: To determine whether community-dwelling, non-obese women ages 55-69 consuming two 12-ounce servings of 100% watermelon juice per day versus placebo for four weeks will demonstrate:
- increases in circulating levels of serum lycopene, citrulline, and arginine using ultra high performance liquid chromatography with photodiode array detector (UPLC-PDA).
- improvement in antioxidant status as assessed by the oxygen radical absorbance capacity assay (ORAC) of whole and deproteinated serum
- decreases in circulating biomarkers of inflammation Hypotheses: Four-week dietary supplementation with 100% watermelon juice will result in increased antioxidant capacity and decreased inflammation, related to increased serum lycopene, citrulline, and arginine
- Clinical: To determine whether community-dwelling, women ages 55-69 consuming two 12-ounce servings of 100% watermelon juice per day versus placebo for four weeks will exhibit:
- improved vascular endothelial function as assessed by flow-mediated dilation (FMD) and decreased arterial stiffness as assessed by pulse wave analysis (PWA)
- decreased low density lipoprotein (LDL) oxidation as assessed by enzyme immunoassay Hypotheses: Four-week dietary supplementation with 100% watermelon juice will result in improved vascular endothelial function, decreased arterial stiffness, and decreased LDL oxidation.
- Conditions
- Arterial Stiffness, Inflammation
- Being tested
- 100% watermelon juice, Placebo beverage
- Medical subject headings
- Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
100% watermelon juiceDietary supplement
Participants drank two 12-ounce servings of 100% watermelon juice per day for a four-week period.
Placebo beverageOther
Participants drank two 12-ounce servings of a placebo beverage per day for a four-week period.
| Study group | Role | What they receive |
|---|---|---|
| Consumption of 100% watermelon juice | Active comparator | Consumption of two 12-ounce doses of pasteurized 100% watermelon juice for a four-week period Receives: 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 Receives: Other: Placebo beverage |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 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.
Measured: Baseline and 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2018
- Study start16 Feb 2016
- Primary completion12 May 2018
- Study completion12 May 2018
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 (3)Papers the sponsor has linked to this study.
- Other trials for Arterial StiffnessStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Model description
- 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.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 21 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 BirminghamKristi Crowe-White, PhD, RD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03626168
- Sponsor's protocol ID
- 16MCPRP27260233
- Acronym
- MOXIE
- Status last verified
- May 2022
- First submitted
- 24 Jul 2018
- Last updated
- 17 May 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 27897608Ellis 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.
PubMed 34344546Crowe-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.
PubMed 32695957
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bioactive Compounds in Watermelon Modulating Oxidative Stress and Inflammation in Elders: The MOXIE Study
- ClinicalTrials.gov ID
- NCT03626168
- Acronym / sponsor ID
- MOXIE / 16MCPRP27260233
- Conditions
- Arterial Stiffness, Inflammation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- University of Alabama, TuscaloosaUniversity, hospital or other
- Study start
- 16 Feb 2016 (actual)
- Primary completion
- 12 May 2018 (actual)
- Study completion
- 12 May 2018 (actual)
- First posted
- 10 Aug 2018 (actual)
- Results
- Posted 17 May 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Purpose and Objectives:
Vascular endothelial dysfunction is an early independent predictor of cardiovascular diseases (CVD), the leading cause of death for women ages 60 and older in the United States1. It is well-known that age-related decreases in vascular endothelial function are partially due to increases in oxidative stress and inflammation.In attempts to combat CVD, previous intervention studies have investigated provision of isolated bioactive food compounds (BFC) in supplemental form. For example, purified lycopene has been shown to decrease oxidative stress, and our previous work supports the supplemental use of glutamine and arginine in improving vascular endothelial function of older adults. Arginine is a precursor for the vasodilatory molecule nitric oxide (NO), and both glutamine and arginine have been shown to attenuate inflammation. Thus, if supplemented together, these compounds would be expected to exert synergist mechanistic effects that improve vascular function.
Watermelon is one of the richest sources of lycopene, and it is among the greatest plant sources of arginine and glutamine. Watermelon also provides high amounts of citrulline (a precursor of arginine) along with the antioxidant ascorbic acid, which enhances the antioxidant and anti-inflammatory effects of carotenoids such as lycopene in biological samples. To date, clinical studies evaluating the potential synergy of these compounds provided by the whole food are lacking on mechanistic and clinical outcomes of CVD. The effects of watermelon supplementation on robust measures of vascular function, inflammation, and oxidative stress in women ages 60 and older are unknown. This study will evaluate the possible impact of multiple bioactive compounds in the natural food matrix of watermelon in order to fully characterize their potential synergy and their influence on CVD risk. Specifically, our proposed study seeks to evaluate the influence of bioactive compounds in 100% watermelon juice, a convenient serving alternative to fresh fruit, using a randomized, double-blind placebo-controlled trial with a crossover design.
Specific Aims:
- Mechanistic: To determine whether community-dwelling, non-obese women ages 55-69 consuming two 12-ounce servings of 100% watermelon juice per day versus placebo for four weeks will demonstrate:
- increases in circulating levels of serum lycopene, citrulline, and arginine using ultra high performance liquid chromatography with photodiode array detector (UPLC-PDA).
- improvement in antioxidant status as assessed by the oxygen radical absorbance capacity assay (ORAC) of whole and deproteinated serum
- decreases in circulating biomarkers of inflammation Hypotheses: Four-week dietary supplementation with 100% watermelon juice will result in increased antioxidant capacity and decreased inflammation, related to increased serum lycopene, citrulline, and arginine
- Clinical: To determine whether community-dwelling, women ages 55-69 consuming two 12-ounce servings of 100% watermelon juice per day versus placebo for four weeks will exhibit:
- improved vascular endothelial function as assessed by flow-mediated dilation (FMD) and decreased arterial stiffness as assessed by pulse wave analysis (PWA)
- decreased low density lipoprotein (LDL) oxidation as assessed by enzyme immunoassay Hypotheses: Four-week dietary supplementation with 100% watermelon juice will result in improved vascular endothelial function, decreased arterial stiffness, and decreased LDL oxidation.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Consumption of 100% watermelon juice | Active comparator | Dietary Supplement: 100% watermelon juiceConsumption of two 12-ounce doses of pasteurized 100% watermelon juice for a four-week period |
| Consumption of a placebo beverage | Placebo comparator | Other: Placebo beverageConsumption of a placebo beverage with comparable sugar content, pH, taste, texture, and color for a four-week period |
Who may qualify
- Ages
- 55 to 69 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Ambulatory
- Female
- Age 55-69 years
- Body mass index 18.5 - 29.9 kg/m2 (non-obese)
Key exclusion criteria (5 listed)
- 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
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 drank two 12-ounce servings of 100% watermelon juice per day for a four-week period. | Dietary supplement | Consumption of 100% watermelon juice |
| Placebo beverageParticipants drank two 12-ounce servings of a placebo beverage per day for a four-week period. | Other | Consumption of a placebo beverage |
Primary outcome
Change From Baseline in Serum Levels of Lycopene at 4 Weeks
Time frame: Baseline and 4 Weeks
Lycopene determined by ultra high performance liquid chromatography with photodiode array detector (UPLC-PDA).
Change in Vascular Endothelial Function at 4 Weeks
Time frame: Baseline and 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.
Change in Arterial Stiffness at 4 Weeks
Time frame: Baseline and 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 27897608Ellis 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.
- Derived from this study: PubMed 34344546Ellis 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.
- Derived from this study: PubMed 32695957Crowe-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.
- Individual participant dataSharing planned: No
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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
Kristi Crowe-White, PhD, RD principal investigator
University of Alabama at Birmingham
Questions about this trial
What is this clinical trial studying?
A study testing 100% watermelon juice in people with Arterial Stiffness and Inflammation, run by University of Alabama, Tuscaloosa.
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 5 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 17 May 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 17 May 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 Serum Levels of Lycopene at 4 Weeks (time frame: Baseline and 4 Weeks). The study lists 3 primary outcomes in all. 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 NCT03626168, which also lists 3 linked publications.
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 17 May 2022.