Tart Cherries and Melatonin Content

NCT ID: NCT01528202

Last Updated: 2012-02-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-04-30
• Study Completion Date: 2011-06-30

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.

Conditions

Sleep

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Baseline placebo

measures taken before administration of placebo

Group Type: NO_INTERVENTION

No interventions assigned to this group

Placebo

Placebo intervention given after 'baseline placebo' arm

Group Type: PLACEBO_COMPARATOR

Fruit juice cordial

Intervention Type: DIETARY_SUPPLEMENT

fruit flavoured juice concentrate

baseline cherry juice

measures taken before the cherry juice intervention

Group Type: NO_INTERVENTION

No interventions assigned to this group

cherry juice

trial where cherry juice is taken following the 'baseline cherry juice' arm

Group Type: EXPERIMENTAL

Cherry juice

Intervention Type: DIETARY_SUPPLEMENT

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

Interventions

Cherry juice

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

Intervention Type: DIETARY_SUPPLEMENT

Fruit juice cordial

fruit flavoured juice concentrate

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

CherryActive concentrate; Apple and blackcurrent squash (0164 9338). Sainsbry's Supermarkets Ltd.

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 39 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Surrey

OTHER

Sponsor Role: collaborator

Northumbria University

OTHER

Sponsor Role: lead

Responsible Party

Dr. Glyn Howatson

Laboratory Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Glyn Howatson, PhD

Role: PRINCIPAL_INVESTIGATOR

Northumbria University

Locations

Northumbria University

Newcastle upon Tyne, Tyne and Wear, United Kingdom

Countries

United Kingdom

Other Identifiers

SLS_SUB60

Identifier Type: -

Identifier Source: org_study_id