Tart Cherries and Melatonin Content
This study has been completed.
Sponsor:
Northumbria University
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
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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
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 May 16, 2013