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Completed

NCT Number: NCT01528202

Tart Cherries and Melatonin Content

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.

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Key information

Conditions

Age range

18 year–39 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Northumbria University

Newcastle upon Tyne, Tyne and Wear, NE1 8ST, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Cherry juice

Dietary Supplement

30 mLs preceding morning meal and 30 mLs preceding evening meal each day for 7 days.

Other names: CherryActive concentrate

Fruit juice cordial

Dietary Supplement

fruit flavoured juice concentrate

Other names: Apple and blackcurrent squash (0164 9338). Sainsbry's Supermarkets Ltd.

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Northumbria University

Other

Collaborators

  • University of Surrey

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Feb 7, 2012
Registry last updated
Feb 7, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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