Tart Cherries and Melatonin Content
Effect of Tart Cherry Juice (Prunus Cerasus) on Melatonin Levels and Sleep Quality
1 other identifier
interventional
20
1 country
1
Brief Summary
The aim of this investigation was to examine the effects of tart Montmorency cherry juice on urinary 6-sulfatoxymelatonin and sleep quality using a double-blind, placebo-controlled, cross-over design.
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 2010
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, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2011
CompletedFirst Submitted
Initial submission to the registry
February 3, 2012
CompletedFirst Posted
Study publicly available on registry
February 7, 2012
CompletedFebruary 7, 2012
February 1, 2012
10 months
February 3, 2012
February 3, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
urinary 6-sulphatoxymelatonin
urinary 6-sulphatoxymelatonin is the primary metabolite of melatonin and provides a sarrogate marker of melatonin metabolism. By measuring over a 48 h period it is possible to examine the circadian rhythm of melatonin.
continually for 48 hours
Secondary Outcomes (1)
Sleep quality
continually throughout the duration of the study
Study Arms (4)
Baseline placebo
NO INTERVENTIONmeasures taken before administration of placebo
Placebo
PLACEBO COMPARATORPlacebo intervention given after 'baseline placebo' arm
baseline cherry juice
NO INTERVENTIONmeasures taken before the cherry juice intervention
cherry juice
EXPERIMENTALtrial where cherry juice is taken following the 'baseline cherry juice' arm
Interventions
30 mLs preceding morning meal and 30 mLs preceding evening meal each day for 7 days.
fruit flavoured juice concentrate
Eligibility Criteria
You may qualify if:
- Equal numbers of healthy, non-pathological males and females aged between 18-39.
You may not qualify if:
- history of epilepsy, current episode of major depressive disorder or anxiety disorder, or a current sleep problem or an inability to comprehend English, travel over two time zones within the last six months, excessive alcohol (over 3 units per day) or caffeine consumption (more than 6 caffeinated drinks or 1 after 6pm), a smoker, a shift worker, a familial history of diabetes, users of medication or supplements, or if the participant is pregnant or currently lactating.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Northumbria Universitylead
- University of Surreycollaborator
Study Sites (1)
Northumbria University
Newcastle upon Tyne, Tyne and Wear, NE1 8ST, United Kingdom
Study Officials
- PRINCIPAL INVESTIGATOR
Glyn Howatson, PhD
Northumbria University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Laboratory Director
Study Record Dates
First Submitted
February 3, 2012
First Posted
February 7, 2012
Study Start
April 1, 2010
Primary Completion
February 1, 2011
Study Completion
June 1, 2011
Last Updated
February 7, 2012
Record last verified: 2012-02