Tart Cherries and Melatonin Content

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Effect of Tart Cherry Juice (Prunus Cerasus) on Melatonin Levels and Sleep Quality

Conditions
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Sleep

Intervention / Treatment
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* Dietary Supplement: Cherry juice
* Dietary Supplement: Fruit juice cordial


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 39 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Baseline placebo<br>measures taken before administration of placebo | |
| Placebo Comparator: Placebo<br>Placebo intervention given after 'baseline placebo' arm | Dietary Supplement: Fruit juice cordial<br>* fruit flavoured juice concentrate<br>* Other names: Apple and blackcurrent squash (0164 9338). Sainsbry's Supermarkets Ltd.;|
| No Intervention: baseline cherry juice<br>measures taken before the cherry juice intervention | |
| Experimental: cherry juice<br>trial where cherry juice is taken following the 'baseline cherry juice' arm | Dietary Supplement: Cherry juice<br>* 30 mLs preceding morning meal and 30 mLs preceding evening meal each day for 7 days.<br>* Other names: CherryActive concentrate;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sleep quality | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sleep, circadian cycle, melatonin