- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01528202
Tart Cherries and Melatonin Content
February 3, 2012 updated by: Dr. Glyn Howatson, Northumbria University
Effect of Tart Cherry Juice (Prunus Cerasus) on Melatonin Levels and Sleep Quality
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The aim of the study is to examine the efficacy of tart cherry juice on sleep quality, quantity, and timing.
Naturally circulating melatonin is instrumental in regulating sleep/wake schedules.
Tart Montmorency cherries (Prunus Cerasus) contain high levels of melatonin and may be a useful intervention to supplement for realignment of circadian phase and by increasing the robustness of circadian amplitude.
In normal healthy adults, with experimentally induced phase advanced circadian misalignment, the administration of a 3mg supplement of melatonin significantly increased sleep architecture characteristics.
In this study we want to examine the efficacy of tart cherry juice in increasing urinary levels of melatonin and the subsequent impact this will have on sleep parameters.
Study Type
Interventional
Enrollment (Actual)
20
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Tyne and Wear
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Newcastle upon Tyne, Tyne and Wear, United Kingdom, NE1 8ST
- Northumbria University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 39 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Equal numbers of healthy, non-pathological males and females aged between 18-39.
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: TRIPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
NO_INTERVENTION: Baseline placebo
measures taken before administration of placebo
|
|
PLACEBO_COMPARATOR: Placebo
Placebo intervention given after 'baseline placebo' arm
|
fruit flavoured juice concentrate
Other Names:
|
NO_INTERVENTION: baseline cherry juice
measures taken before the cherry juice intervention
|
|
EXPERIMENTAL: cherry juice
trial where cherry juice is taken following the 'baseline cherry juice' arm
|
30 mLs preceding morning meal and 30 mLs preceding evening meal each day for 7 days.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
urinary 6-sulphatoxymelatonin
Time Frame: continually for 48 hours
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Sleep quality
Time Frame: continually throughout the duration of the study
|
Acti watches quantitively measure sleep and activity of participants, whereas slep recall provides a retrospective and subjective m,easure of sleep quality.
|
continually throughout the duration of the study
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2010
Primary Completion (ACTUAL)
February 1, 2011
Study Completion (ACTUAL)
June 1, 2011
Study Registration Dates
First Submitted
February 3, 2012
First Submitted That Met QC Criteria
February 3, 2012
First Posted (ESTIMATE)
February 7, 2012
Study Record Updates
Last Update Posted (ESTIMATE)
February 7, 2012
Last Update Submitted That Met QC Criteria
February 3, 2012
Last Verified
February 1, 2012
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- SLS_SUB60
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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