NCT04328311

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 7, 2020

Completed
1 day until next milestone

Study Start

First participant enrolled

January 8, 2020

Completed
3 months until next milestone

First Posted

Study publicly available on registry

March 31, 2020

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2022

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2024

Completed
Last Updated

November 22, 2024

Status Verified

January 1, 2024

Enrollment Period

3 years

First QC Date

January 7, 2020

Last Update Submit

November 20, 2024

Conditions

Keywords

WatermelonL-citrullineBlood pressure

Outcome Measures

Primary Outcomes (1)

  • Change in blood pressure

    Blood pressure by automated device

    At baseline (t= 0 hours) and 15 minute intervals until t= 2 hours.

Secondary Outcomes (3)

  • Change in NOx (nitric oxide metabolites)

    At baseline (t= 0 hours) and t=1.5 hours.

  • Change in l-arginine

    At baseline (t= 0 hours) and t=1.5 hours.

  • Change in l-citrulline

    At baseline (t= 0 hours) and t=1.5 hours.

Study Arms (2)

Active

EXPERIMENTAL

Watermelon juice

Other: Watermelon Juice

Control

OTHER

Low nitrate water.

Other: Water

Interventions

500 mL watermelon juice (What a Melon), containing \~1 g of L-citrulline.

Active
WaterOTHER

500 mL low nitrate water

Control

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Males and females
  • years

You may not qualify if:

  • Able to understand information sheet
  • Willing to comply with the study protocol
  • Able to give informed consent.
  • 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
  • +7 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Reading

Reading, UK, RG6 6AH, United Kingdom

Location

MeSH Terms

Interventions

Water

Intervention Hierarchy (Ancestors)

HydroxidesAlkaliesInorganic ChemicalsAnionsIonsElectrolytesOxidesOxygen Compounds

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

January 7, 2020

First Posted

March 31, 2020

Study Start

January 8, 2020

Primary Completion

December 30, 2022

Study Completion

December 30, 2024

Last Updated

November 22, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations