- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04207281
Honey to Improve Sleep Quality
Honey to Improve Sleep Quality: a Randomized, Double-blind Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Inadequate sleep quality and duration may result in adverse health outcomes and poorer quality of life. Research thus far identify interventions such as behavior modification and pharmaceuticals to aid sleep. According to Stats Canada (2007-2013 Canadian Health Measures Survey), despite these available interventions, roughly half of men and women (43% and 55%, respectively) aged 18-64 have difficulty falling or staying asleep; these results are similar to those reported in 2005. The lack of improvement in sleep might reflect important limitations with the current interventions; individuals with sleep disorders may find adherence to such interventions difficult to maintain (e.g. behavior modification) or the therapies may pose a risk (e.g. dependence on pharmaceuticals). There is a clear need for alternative therapeutic interventions, particularly those that are simple and cost effective.
Observational and anecdotal evidence supports honey as an alternative to promote better sleep. During sleep, the brain typically utilizes liver glycogen stores to provide continuous and adequate energy; foods that promote liver glycogen storage before sleep may ensure availability of this energy source and therefore lead to better sleep.4 Raw honey is a rapidly digestible and metabolizable dense energy source, and thus may provide this sleep time energy reserve. Additionally, honey may promote melatonin formation due to its possible tryptophan content (a precursor to melatonin) that both helps to initiate sleep as well as promote release of hormones that facilitate whole body recovery during sleep.
Based on this information, we completed a preliminary open-label proof-of-principle study to assess the feasibility and potential effectiveness of honey in improving sleep quality. In a cross-over study of poor sleepers, honey improved some areas of sleep compared to melatonin. The results of this study are the driving factor for the randomized, double-blind, cross-over study in poor sleepers proposed here.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Whitney Duff, PhD
- Phone Number: 13069661852
- Email: whitney.duff@usask.ca
Study Locations
-
-
Saskatchewan
-
Saskatoon, Saskatchewan, Canada, S7N 5E5
- Recruiting
- University of Saskatchewan
-
Contact:
- Whitney Duff, PhD
- Phone Number: 3067172217
- Email: whitney.duff@usask.ca
-
Contact:
- Stephanie Vuong, MSc
- Phone Number: 3063701983
- Email: steph.vuong@usask.ca
-
Principal Investigator:
- Jane Alcorn, PhD
-
Sub-Investigator:
- Neil Specht
-
Sub-Investigator:
- Whitney Duff, PhD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Aged 18 - 55yrs
- Male or female
- Able to comply with study protocol and give informed consent
- Healthy (no diagnosis of medical or mental illness and not suffering from vascular disease, diabetes mellitus, hyperlipidemia, obesity [body mass index over 30], dermatological disease, gynecological disease, endocrine disease)
- Discontinuation of sleep aids 4 weeks in advance of the study
- Self-report of having difficulty sleeping for 1 week or more
Exclusion Criteria:
- Age: <18 and >55
- Type I and Type II diabetes, current infectious disease (e.g. cold or flu)
- Unstable medical condition
- History of psychiatric disorder (past or present)
- Pain syndrome affecting sleep
- Obese (BMI over 30)
- Pregnant or lactating women
- Lifestyle habits that would modify the wake-sleep rhythm (e.g. night work; shift work; young children that interrupt sleep)
- Substance and/or drug dependence (alcohol, nicotine, pain killers)
- Use of the following medications during the study period: oral or injectable corticosteroid, sedating antihistamines (e.g. cold, allergy, motion sickness), psychotropic medications or hypnotics, benzodiazepine, narcotics, any illicit drugs
- Use of stimulants (>4 cups [1 cup = 250 mL] of coffee/day)
- Participation in any other clinical trial with an investigational agent within one month prior to randomization
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Honey
Raw honey (1.5 tablespoons)
|
Canada #2 white raw honey (1.5 tablespoons) supplied by SweetHeart Pollinators (Janeil Enterprises, Eatonia, SK) administered for 7 days
Honey comparator(1.5 tablespoons) administered for 7 days
|
Placebo Comparator: Comparator
Honey comparator(1.5 tablespoons)
|
Canada #2 white raw honey (1.5 tablespoons) supplied by SweetHeart Pollinators (Janeil Enterprises, Eatonia, SK) administered for 7 days
Honey comparator(1.5 tablespoons) administered for 7 days
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Sleep quality as measured by Leeds Sleep Evaluation Questionnaire
Time Frame: 14 days
|
Assessment of the quality of sleep as measured by a standardized tool, the Leeds Sleep Evaluation Questionnaire, which assesses subjective measures of sleep quality and amount, by the end of the 7 day intervention with the treatments (honey or comparator)
|
14 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Sleep quality as measured by daily sleep hygiene logs
Time Frame: 14 days
|
Assessment of the quality of sleep as measured by a daily sleep hygiene log, which assesses subjective measures of sleep quality and amount by the end of the 7 day intervention with the treatments (honey or comparator)
|
14 days
|
Sleep quality as measured by daily morning sleep logs
Time Frame: 14 days
|
Assessment of the quality of sleep as measured by a daily morning sleep log, which assesses subjective measures of sleep quality and amount by the end of the 7 day intervention with the treatments (honey or comparator)
|
14 days
|
Sleep quality as measured by actigraphy
Time Frame: 14 days
|
Assessment of the quality of sleep as measured by actigraphy, which assesses objective measures of sleep quality and amount by the end of the 7 day intervention with the treatments (honey or comparator)
|
14 days
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- Bio-1666
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
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