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Tart Cherries and Melatonin Content

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01528202
Recruitment Status : Completed
First Posted : February 7, 2012
Last Update Posted : February 7, 2012
University of Surrey
Information provided by (Responsible Party):
Dr. Glyn Howatson, Northumbria University

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.

Condition or disease Intervention/treatment Phase
Sleep Dietary Supplement: Cherry juice Dietary Supplement: Fruit juice cordial Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Tart Cherry Juice (Prunus Cerasus) on Melatonin Levels and Sleep Quality
Study Start Date : April 2010
Actual Primary Completion Date : February 2011
Actual Study Completion Date : June 2011

Resource links provided by the National Library of Medicine

Drug Information available for: Melatonin

Arm Intervention/treatment
No Intervention: Baseline placebo
measures taken before administration of placebo
Placebo Comparator: Placebo
Placebo intervention given after 'baseline placebo' arm
Dietary Supplement: Fruit juice cordial
fruit flavoured juice concentrate
Other Name: Apple and blackcurrent squash (0164 9338). Sainsbry's Supermarkets Ltd.

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
Dietary Supplement: Cherry juice
30 mLs preceding morning meal and 30 mLs preceding evening meal each day for 7 days.
Other Name: CherryActive concentrate

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 39 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01528202

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United Kingdom
Northumbria University
Newcastle upon Tyne, Tyne and Wear, United Kingdom, NE1 8ST
Sponsors and Collaborators
Northumbria University
University of Surrey
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Principal Investigator: Glyn Howatson, PhD Northumbria University

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Responsible Party: Dr. Glyn Howatson, Laboratory Director, Northumbria University Identifier: NCT01528202    
Other Study ID Numbers: SLS_SUB60
First Posted: February 7, 2012    Key Record Dates
Last Update Posted: February 7, 2012
Last Verified: February 2012
Keywords provided by Dr. Glyn Howatson, Northumbria University:
Sleep, circadian cycle, melatonin
Additional relevant MeSH terms:
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Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Central Nervous System Depressants