Honey to Improve Sleep Quality

• ClinicalTrials.gov Identifier: NCT04207281
• Recruitment Status: Recruiting
• First Posted: December 20, 2019
• Last Update Posted: May 6, 2023
• Sponsor: University of Saskatchewan
• Information provided by (Responsible Party): Jane Alcorn, University of Saskatchewan

Tracking Information

• First Submitted Date: December 18, 2019
• First Posted Date: December 20, 2019
• Last Update Posted Date: May 6, 2023
• Actual Study Start Date: April 1, 2021
• Estimated Primary Completion Date: September 1, 2024 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: March 31, 2021)

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)

Original Primary Outcome Measures (submitted: December 18, 2019)

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 placebo)

Current Secondary Outcome Measures (submitted: March 31, 2021)

• 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)
• 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)
• 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)

Original Secondary Outcome Measures (submitted: December 18, 2019)

• 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 placebo)
• 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 placebo)
• 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 placebo)

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Honey to Improve Sleep Quality
• Official Title: Honey to Improve Sleep Quality: a Randomized, Double-blind Trial
• Brief Summary: Inadequate sleep quality and duration affects quality of life, and can cause adverse health outcomes, for many Canadians. Existing sleep therapies have limitations, such as inability to adhere to a cognitive behaviour modification or the risk of dependence on pharmaceutical therapies. Raw honey has a long history of anecdotal reports supporting its use to improve sleep quality. In an effort to develop an evidence base for honey as a sleep aid, we completed a preliminary proof-of-principle study to assess feasibility and potential effectiveness of honey to improve sleep quality. Results of our preliminary study demonstrate that honey is safe and effective for improving quality of sleep with no associated adverse effects, as compared to melatonin. The current study design builds off the experiences of the preliminary trial and will add more scientific rigor to the evidence base we have started to build.

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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: Triple (Participant, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Poor Quality Sleep

Intervention

• Dietary Supplement: Raw Honey
  Canada #2 white raw honey (1.5 tablespoons) supplied by SweetHeart Pollinators (Janeil Enterprises, Eatonia, SK) administered for 7 days
• Dietary Supplement: Comparator
  Honey comparator(1.5 tablespoons) administered for 7 days

Study Arms

• Active Comparator: Honey
  Raw honey (1.5 tablespoons)
  Interventions:

  • Dietary Supplement: Raw Honey
  • Dietary Supplement: Comparator
• Placebo Comparator: Comparator
  Honey comparator(1.5 tablespoons)
  Interventions:

  • Dietary Supplement: Raw Honey
  • Dietary Supplement: Comparator

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: December 18, 2019): 110
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: September 1, 2024
• Estimated Primary Completion Date: September 1, 2024 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 55 Years (Adult)
• Accepts Healthy Volunteers: Yes

Contacts

Contact: Whitney Duff, PhD; 13069661852; whitney.duff@usask.ca

• Listed Location Countries: Canada

Administrative Information

• NCT Number: NCT04207281
• Other Study ID Numbers: Bio-1666
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Jane Alcorn, University of Saskatchewan
• Original Responsible Party: Jane Alcorn, University of Saskatchewan, PhD
• Current Study Sponsor: University of Saskatchewan
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Jane Alcorn, PhD; University of Saskatchewan

• PRS Account: University of Saskatchewan
• Verification Date: May 2023