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Tart Cherries and Melatonin Content

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ClinicalTrials.gov Identifier: NCT01528202
Recruitment Status : Completed
First Posted : February 7, 2012
Last Update Posted : February 7, 2012
Sponsor:
Collaborator:
University of Surrey
Information provided by (Responsible Party):
Dr. Glyn Howatson, Northumbria University

Tracking Information
First Submitted Date  ICMJE February 3, 2012
First Posted Date  ICMJE February 7, 2012
Last Update Posted Date February 7, 2012
Study Start Date  ICMJE April 2010
Actual Primary Completion Date February 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 3, 2012)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: February 3, 2012)
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Tart Cherries and Melatonin Content
Official Title  ICMJE Effect of Tart Cherry Juice (Prunus Cerasus) on Melatonin Levels and Sleep Quality
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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Sleep
Intervention  ICMJE
  • Dietary Supplement: Cherry juice
    30 mLs preceding morning meal and 30 mLs preceding evening meal each day for 7 days.
    Other Name: CherryActive concentrate
  • Dietary Supplement: Fruit juice cordial
    fruit flavoured juice concentrate
    Other Name: Apple and blackcurrent squash (0164 9338). Sainsbry's Supermarkets Ltd.
Study Arms  ICMJE
  • No Intervention: Baseline placebo
    measures taken before administration of placebo
  • Placebo Comparator: Placebo
    Placebo intervention given after 'baseline placebo' arm
    Intervention: Dietary Supplement: Fruit juice cordial
  • 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
    Intervention: Dietary Supplement: Cherry juice
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 3, 2012)
20
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2011
Actual Primary Completion Date February 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 39 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01528202
Other Study ID Numbers  ICMJE SLS_SUB60
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dr. Glyn Howatson, Northumbria University
Study Sponsor  ICMJE Northumbria University
Collaborators  ICMJE University of Surrey
Investigators  ICMJE
Principal Investigator: Glyn Howatson, PhD Northumbria University
PRS Account Northumbria University
Verification Date February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP