NCT04840160

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

87
On Track

Trial Health Score

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

Enrollment
23

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

April 1, 2016

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2017

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2019

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

April 6, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 9, 2021

Completed
Last Updated

April 9, 2021

Status Verified

April 1, 2021

Enrollment Period

1.3 years

First QC Date

April 6, 2021

Last Update Submit

April 8, 2021

Conditions

Keywords

cherryanthocyaninvascular functionmetabolomics

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 COMPARATOR

Participants 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.

Dietary Supplement: Placebo

Cherry juice

EXPERIMENTAL

Participants 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.

Dietary Supplement: Cherry juice

Interventions

Cherry juiceDIETARY_SUPPLEMENT

A tart cherry juice intervention

Cherry juice
PlaceboDIETARY_SUPPLEMENT

A tart cherry juice placebo

Placebo

Eligibility Criteria

Age19 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

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

Location

Study Officials

  • Glyn Howatson

    Northumbria University

    PRINCIPAL INVESTIGATOR

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
Model Details: Randomised controlled trial
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

Locations