- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04328311
The Impact of Watermelon Juice on Blood Pressure
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
UK
-
Reading, UK, United Kingdom, RG6 6AH
- University of Reading
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Active
Watermelon juice
|
500 mL watermelon juice (What a Melon), containing ~1 g of L-citrulline.
|
|
Other: Control
Low nitrate water.
|
500 mL low nitrate water
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in blood pressure
Time Frame: At baseline (t= 0 hours) and 15 minute intervals until t= 2 hours.
|
Blood pressure by automated device
|
At baseline (t= 0 hours) and 15 minute intervals until t= 2 hours.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in NOx (nitric oxide metabolites)
Time Frame: At baseline (t= 0 hours) and t=1.5 hours.
|
Plasma nitrate and nitrite concentration
|
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.
|
L-arginine concentration
|
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.
|
L-citrulline concentration
|
At baseline (t= 0 hours) and t=1.5 hours.
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 34/19
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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