Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Honey to Improve Sleep Quality: a Feasibility Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03567395
Recruitment Status : Completed
First Posted : June 25, 2018
Last Update Posted : April 30, 2019
Sponsor:
Information provided by (Responsible Party):
Jane Alcorn, University of Saskatchewan

Brief Summary:
Inadequate sleep quality and duration may result in adverse health outcomes and poorer quality of life. Despite the availability of behavior modification and pharmaceuticals to aid sleep optimization and quality approximately 50% men and women continue to experience difficulty falling asleep or staying asleep. 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). A need exists for alternative therapeutic interventions, particularly those that are simple and cost effective. Observational and anecdotal data supports honey as a functional food to promote better sleep. As an initial step towards developing an evidence base for honey for improvement of sleep quality the investigators propose to conduct a preliminary open-label proof-of-principle study to assess the feasibility (primary outcome) and potential effectiveness (secondary outcome) of honey in improving sleep quality before embarking upon a full-scale pivotal clinical trial. The study data will confirm safety of honey use in a population of poor sleepers and to identify where improvements in study design are necessary in planning of a larger clinical trial.

Condition or disease Intervention/treatment Phase
Poor Quality Sleep Dietary Supplement: Melatonin Dietary Supplement: Honey Not Applicable

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Honey to Improve Sleep Quality: a Feasibility Study
Actual Study Start Date : April 18, 2018
Actual Primary Completion Date : September 30, 2018
Actual Study Completion Date : December 15, 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Melatonin

Arm Intervention/treatment
Active Comparator: Melatonin
Melatonin (5 mg sublingual tablet)
Dietary Supplement: Melatonin
Melatonin (5 mg sublingual tablet) administered for 3 days

Experimental: Honey
raw honey (1.5 tablespoons)
Dietary Supplement: Honey
Raw Honey (1.5 tablespoons) administered for 3 days




Primary Outcome Measures :
  1. Completion of sleep hygiene log [ Time Frame: 2 weeks ]
    Feasibility of participants to be compliant to a required sleep quality measurement tool, the sleep hygiene log

  2. Completion of morning sleep log [ Time Frame: 2 weeks ]
    Feasibility of participants to be compliant to a required sleep quality measurement tool, the morning sleep log

  3. Completion of Leeds Sleep Evaluation Questionnaire [ Time Frame: 2 weeks ]
    Feasibility of participants to be compliant to standardized assessment tool of sleep quality, the Leeds Sleep Evaluation Questionnaire. This questionnaire consists of 10 questions with a scale from 1 - 9, the highest number for each symptom measured representing the best sleep quality. Score of 5 is the baseline such that a score of 5 indicates no change and a higher or lower value from 5 indicates a change in a symptom. A total score will be reported to determine whether the intervention resulted in a change in sleep quality.


Secondary Outcome Measures :
  1. Sleep quality as measured by daily sleep hygiene log [ Time Frame: 6 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 3 day intervention with the treatments (honey or melatonin)

  2. Sleep quality as measured by daily morning sleep log [ Time Frame: 6 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 3 day intervention with the treatments (honey or melatonin)

  3. Sleep quality as measured by Leeds Sleep Evaluation [ Time Frame: 6 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 3 day intervention with the treatments (honey or melatonin)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Age: 18 - 55

  • Male or female
  • Able to comply with study protocol and give informed consent
  • Healthy (no diagnosis of medical or mental illness) (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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03567395


Locations
Layout table for location information
Canada, Saskatchewan
Medicine Shoppe
Saskatoon, Saskatchewan, Canada
Sponsors and Collaborators
University of Saskatchewan
Investigators
Layout table for investigator information
Principal Investigator: Jane Alcorn, PhD University of Saskatchewan

Layout table for additonal information
Responsible Party: Jane Alcorn, Associate Dean Research and Graduate Affairs, University of Saskatchewan
ClinicalTrials.gov Identifier: NCT03567395    
Other Study ID Numbers: BIO 018-31
First Posted: June 25, 2018    Key Record Dates
Last Update Posted: April 30, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Melatonin
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Central Nervous System Depressants