Tart Cherries and Melatonin Content

This study has been completed.
Sponsor:
Collaborator:
University of Surrey
Information provided by (Responsible Party):
Dr. Glyn Howatson, Northumbria University
ClinicalTrials.gov Identifier:
NCT01528202
First received: February 3, 2012
Last updated: NA
Last verified: February 2012
History: No changes posted
  Purpose

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 Intervention
Sleep
Dietary Supplement: Cherry juice
Dietary Supplement: Fruit juice cordial

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Tart Cherry Juice (Prunus Cerasus) on Melatonin Levels and Sleep Quality

Resource links provided by NLM:


Further study details as provided by Northumbria University:

Primary Outcome Measures:
  • urinary 6-sulphatoxymelatonin [ Time Frame: continually for 48 hours ] [ Designated as safety issue: No ]
    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:
  • Sleep quality [ Time Frame: continually throughout the duration of the study ] [ Designated as safety issue: No ]
    Acti watches quantitively measure sleep and activity of participants, whereas slep recall provides a retrospective and subjective m,easure of sleep quality.


Enrollment: 20
Study Start Date: April 2010
Study Completion Date: June 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 39 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01528202

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

No publications provided

Responsible Party: Dr. Glyn Howatson, Laboratory Director, Northumbria University
ClinicalTrials.gov Identifier: NCT01528202     History of Changes
Other Study ID Numbers: SLS_SUB60
Study First Received: February 3, 2012
Last Updated: February 3, 2012
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by Northumbria University:
Sleep, circadian cycle, melatonin

Additional relevant MeSH terms:
Melatonin
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents

ClinicalTrials.gov processed this record on July 20, 2014