NCT02984319

Brief Summary

Acute effect of cherry concentrate consumption on flow mediated dilatation in healthy young men

Trial Health

87
On Track

Trial Health Score

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

Enrollment
12

participants targeted

Target at below P25 for not_applicable healthy

Timeline
Completed

Started Nov 2015

Longer than P75 for not_applicable healthy

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

November 1, 2015

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

December 2, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 6, 2016

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2018

Completed
Last Updated

October 25, 2018

Status Verified

October 1, 2018

Enrollment Period

2.2 years

First QC Date

December 2, 2016

Last Update Submit

October 23, 2018

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

  • Flow mediated dilatation

    Change from baseline to 3 hours post dietary supplementation

Secondary Outcomes (2)

  • Microvascular function (laser doppler flowmetry)

    Change from baseline to 3 hours post dietary supplementation

  • Plasma nitrite concentration

    Change from baseline to 3 hours post dietary supplementation

Study Arms (2)

Cherry

ACTIVE COMPARATOR

Cherry concentrate

Dietary Supplement: Cherry versus placebo concentrate

Placebo

PLACEBO COMPARATOR

Placebo concentrate

Dietary Supplement: Cherry versus placebo concentrate

Interventions

Cherry versus placebo concentrateDIETARY_SUPPLEMENT

Acute cherry concentrate

CherryPlacebo

Eligibility Criteria

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

You may qualify if:

  • no prescription medications

You may not qualify if:

  • prescription medications

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sport & Health Sciences

Exeter, Devon, EX1 2LU, United Kingdom

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 2, 2016

First Posted

December 6, 2016

Study Start

November 1, 2015

Primary Completion

January 1, 2018

Study Completion

January 1, 2018

Last Updated

October 25, 2018

Record last verified: 2018-10

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)