Tart Cherries and Melatonin Content

February 3, 2012 updated by: Dr. Glyn Howatson, Northumbria University

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

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.

Study Overview

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

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Tyne and Wear
      • Newcastle upon Tyne, Tyne and Wear, United Kingdom, NE1 8ST
        • Northumbria University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 39 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
NO_INTERVENTION: Baseline placebo
measures taken before administration of placebo
PLACEBO_COMPARATOR: Placebo
Placebo intervention given after 'baseline placebo' arm
fruit flavoured juice concentrate
Other Names:
  • 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
30 mLs preceding morning meal and 30 mLs preceding evening meal each day for 7 days.
Other Names:
  • CherryActive concentrate

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
continually for 48 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
continually throughout the duration of the study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2010

Primary Completion (ACTUAL)

February 1, 2011

Study Completion (ACTUAL)

June 1, 2011

Study Registration Dates

First Submitted

February 3, 2012

First Submitted That Met QC Criteria

February 3, 2012

First Posted (ESTIMATE)

February 7, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

February 7, 2012

Last Update Submitted That Met QC Criteria

February 3, 2012

Last Verified

February 1, 2012

More Information

Terms related to this study

Other Study ID Numbers

  • SLS_SUB60

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Sleep

Clinical Trials on Fruit juice cordial

3
Subscribe