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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04328311
Other study ID # 34/19
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date January 8, 2020
Est. completion date December 30, 2022

Study information

Verified date November 2022
Source University of Reading
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 10
Est. completion date December 30, 2022
Est. primary completion date December 30, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 30 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Watermelon Juice
500 mL watermelon juice (What a Melon), containing ~1 g of L-citrulline.
Water
500 mL low nitrate water

Locations

Country Name City State
United Kingdom University of Reading Reading UK

Sponsors (1)

Lead Sponsor Collaborator
University of Reading

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in blood pressure Blood pressure by automated device At baseline (t= 0 hours) and 15 minute intervals until t= 2 hours.
Secondary Change in NOx (nitric oxide metabolites) Plasma nitrate and nitrite concentration At baseline (t= 0 hours) and t=1.5 hours.
Secondary Change in l-arginine L-arginine concentration At baseline (t= 0 hours) and t=1.5 hours.
Secondary Change in l-citrulline L-citrulline concentration At baseline (t= 0 hours) and t=1.5 hours.
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