Healthy AgingNCT04328311
The Impact of Watermelon Juice on Blood Pressure
A study testing Watermelon Juice and Water in people with Healthy Aging, run by University of Reading at 1 site in United Kingdom.
Trial summary
L-citrulline is found naturally in watermelon. Recently interest has increased for this amino acid due to potential health benefits. Notably, L-citrulline has the potential to lead to dilation of blood vessels due to its involvement in the production of nitric oxide. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Aging
- What is being tested?
- Watermelon Juice and Water
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 8 Jan 2020to 30 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Males and females
- 18-30 years
- Healthy (as per exclusion criteria)
- Able to understand information sheet
- Willing to comply with the study protocol
- Able to give informed consent.
Who cannot join
- Medical history of myocardial infarction
- Medical history of angina
- Medical history of thrombosis
- Medical history of stroke
- Medical history of cancer
- Medical history of high cholesterol
Show all 19Show fewer
- Medical history of liver diseases
- Medical history of renal diseases
- Medical history of respiratory diseases
- Medical history of bowel diseases
- Medical history of diabetes
- Medical history of other endocrine disorders
- BMI <18.5 kg/m2 or >25 kg/m2
- Blood pressure <90/60 or > 140/90 mmHg
- Current use of antihypertensive medication
- Pregnant or lactating
- Alcohol intake > 14 units/week
- Cigarette smoker (or quit within the last 6 months)
- Vigorous exercise > 3 times/ week
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Impact of Watermelon Juice on Blood Pressure in Young Healthy Adults
L-citrulline is found naturally in watermelon. Recently interest has increased for this amino acid due to potential health benefits. Notably, L-citrulline has the potential to lead to dilation of blood vessels due to its involvement in the production of nitric oxide.
The study will be an acute single blind, randomised controlled, crossover intervention study in healthy, young volunteers. Participants receive either the test watermelon drink or control drink (water). Blood samples and vascular measures (by a single-cuff based method) will be measured at baseline. Vascular measures will be repeated at 15-minute intervals between 0-2 hours and a second blood sample will be drawn at 1.5 hours to coincide with the estimated peak plasma L-citrulline. Citrulline, arginine and nitric oxide metabolites will be measured in the blood samples.
- Conditions
- Healthy Aging
- Being tested
- Watermelon Juice, Water
- Keywords
- Watermelon, L-citrulline, Blood pressure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Watermelon JuiceOther
500 mL watermelon juice (What a Melon), containing ~1 g of L-citrulline.
WaterOther
500 mL low nitrate water
| Study group | Role | What they receive |
|---|---|---|
| Active | Experimental | Watermelon juice Receives: Other: Watermelon Juice |
| Control | Other | Low nitrate water. Receives: Other: Water |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in blood pressure
Blood pressure by automated device
Measured: At baseline (t= 0 hours) and 15 minute intervals until t= 2 hours.
Secondary outcomes (3)
Change in NOx (nitric oxide metabolites)
Plasma nitrate and nitrite concentration
Measured: At baseline (t= 0 hours) and t=1.5 hours.
Change in l-arginine
L-arginine concentration
Measured: At baseline (t= 0 hours) and t=1.5 hours.
Change in l-citrulline
L-citrulline concentration
Measured: At baseline (t= 0 hours) and t=1.5 hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2020
- Study start8 Jan 2020
- Primary completion30 Dec 2022
- Study completion30 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy AgingStudies 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
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Reading
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Charlotte E Mills, University of Reading
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04328311
- Sponsor's protocol ID
- 34/19
- Status last verified
- Jan 2024
- First submitted
- 7 Jan 2020
- Last updated
- 22 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Watermelon Juice on Blood Pressure in Young Healthy Adults
- ClinicalTrials.gov ID
- NCT04328311
- Acronym / sponsor ID
- 34/19
- Conditions
- Healthy Aging
- Keywords
- Watermelon, L-citrulline, Blood pressure
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of ReadingUniversity, hospital or other
- Study start
- 8 Jan 2020 (actual)
- Primary completion
- 30 Dec 2022 (actual)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 31 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
L-citrulline is found naturally in watermelon. Recently interest has increased for this amino acid due to potential health benefits. Notably, L-citrulline has the potential to lead to dilation of blood vessels due to its involvement in the production of nitric oxide.
The study will be an acute single blind, randomised controlled, crossover intervention study in healthy, young volunteers. Participants receive either the test watermelon drink or control drink (water). Blood samples and vascular measures (by a single-cuff based method) will be measured at baseline. Vascular measures will be repeated at 15-minute intervals between 0-2 hours and a second blood sample will be drawn at 1.5 hours to coincide with the estimated peak plasma L-citrulline. Citrulline, arginine and nitric oxide metabolites will be measured in the blood samples.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active | Experimental | Other: Watermelon JuiceWatermelon juice |
| Control | Other | Other: WaterLow nitrate water. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Males and females
- 18-30 years
- Healthy (as per exclusion criteria)
- Able to understand information sheet
- Willing to comply with the study protocol
Key exclusion criteria (19 listed)
- Medical history of myocardial infarction
- Medical history of angina
- Medical history of thrombosis
- Medical history of stroke
- Medical history of cancer
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 |
|---|---|---|
| Watermelon Juice500 mL watermelon juice (What a Melon), containing ~1 g of L-citrulline. | Other | Active |
| Water500 mL low nitrate water | Other | Control |
Primary outcome
Change in blood pressure
Time frame: At baseline (t= 0 hours) and 15 minute intervals until t= 2 hours.
Blood pressure by automated device
3 secondary outcomes
Change in NOx (nitric oxide metabolites)
Time frame: At baseline (t= 0 hours) and t=1.5 hours.
Change in l-arginine
Time frame: At baseline (t= 0 hours) and t=1.5 hours.
Change in l-citrulline
Time frame: At baseline (t= 0 hours) and t=1.5 hours.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2024.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Watermelon Juice and Water in people with Healthy Aging, run by University of Reading at 1 site in United Kingdom.
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 6 inclusion and 19 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: status not confirmed, as of the sponsor's last update on 22 Nov 2024. 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 Kingdom. 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?
Results are not available in the source record.
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 in blood pressure (time frame: At baseline (t= 0 hours) and 15 minute intervals until t= 2 hours.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Nov 2024.