Influence of Tart Cherry Juice Intervention on Vascular Function
1 other identifier
interventional
23
1 country
1
Brief Summary
Diets containing fruit rich in anthocyanins have been shown (in meta-analyses) to be beneficial for health, but intervention trials have shown inconsistent results. In this preliminary study we want to investigate the influence of a tart-cherry juice intervention on vascular function and explore metabolite profiles that may offer insight into their mechanism of action
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Apr 2016
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2019
CompletedFirst Submitted
Initial submission to the registry
April 6, 2021
CompletedFirst Posted
Study publicly available on registry
April 9, 2021
CompletedApril 9, 2021
April 1, 2021
1.3 years
April 6, 2021
April 8, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Systolic and diastolic blood pressure
Measurement of systolic and diastolic blood pressure before and after the intervention
Change in blood pressure following 4 weeks intervention
Arterial pulse wave velocity
Measurement of pulse wave velocity before and after the intervention
Change in pulse wave velocity following 4 weeks intervention
Digital volume pulse
Measurement of digital volume pulse before and after the intervention
Change in digital volume pulse following 4 weeks intervention
Secondary Outcomes (1)
Metabolomics
Changes to urinary metabolite profiles following 4 weeks intervention
Study Arms (2)
Placebo
PLACEBO COMPARATORParticipants supplied with 30 ml of a low fruit (\<1%) cordial mixed with maltodextrin and protein diluted in 100 ml water twice daily, once in the morning and evening.
Cherry juice
EXPERIMENTALParticipants supplied with 30 ml of a tart cherry juice concentrate (CherryActive, United Kingdom; (containing 36.8 mg of anthocyanins) diluted in 100 ml of water twice daily, once in the morning and evening.
Interventions
Eligibility Criteria
You may qualify if:
- aged 19-40
- no diagnosed issues with the ability to consume fruit juice
- no known food intolerances to fruits
You may not qualify if:
- participants that are cigarette smokers
- participants diagnosed with hypertension
- participants diagnosed with any form of cardiometabolic diseases
- participants that require any prescribed prescriptions excluding the contraceptive pill
- participants that are regular consumers of cherries (\>100 g/d)
- participants that consume any antioxidant supplements
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Northumberland Building
Newcastle upon Tyne, NE1 7ST, United Kingdom
Study Officials
- PRINCIPAL INVESTIGATOR
Glyn Howatson
Northumbria University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Masking Details
- Participants supplied with treatment or placebo in a plastic container
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 6, 2021
First Posted
April 9, 2021
Study Start
April 1, 2016
Primary Completion
August 1, 2017
Study Completion
August 1, 2019
Last Updated
April 9, 2021
Record last verified: 2021-04
Data Sharing
- IPD Sharing
- Will not share
Research data will be shared on request