Recruiting

Honey

Sponsor:

University of Saskatchewan

Code:

NCT04207281

Conditions

Poor Quality Sleep

Eligibility Criteria

Sex: All

Age: 18 - 55

Healthy Volunteers: Accepted

Interventions

Raw Honey

Comparator

Study Details

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.

Conditions

Poor Quality Sleep

Study ID

NCT04207281

Start date

Apr 1, 2021

Status verified date

May, 2023

Completion date

Sep 1, 2024

Anticipated

Primary completion date

Sep 1, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 55

Healthy Volunteers: Accepted

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 Design

Enrollment

110 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Honey

Raw honey (1.5 tablespoons)

placebo comparator: Comparator

Honey comparator(1.5 tablespoons)

Interventions

Raw Honey

Canada #2 white raw honey (1.5 tablespoons) supplied by SweetHeart Pollinators (Janeil Enterprises, Eatonia, SK) administered for 7 days

Comparator

Honey comparator(1.5 tablespoons) administered for 7 days

Primary outcome measure

  • Sleep quality as measured by Leeds Sleep Evaluation Questionnaire [ Time Frame: 14 days ]

Central Contacts and Locations

Central contacts

Whitney Duff, PhD

13069661852whitney.duff@usask.ca

Locations

University of Saskatchewan

Recruiting

Saskatoon, Saskatchewan, Canada, S7N 5E5

Contacts

Whitney Duff, PhD

3067172217whitney.duff@usask.ca

Stephanie Vuong, MSc

3063701983steph.vuong@usask.ca

Principal Investigator:

Jane Alcorn, PhD

More Information

Sponsor

University of Saskatchewan

Last update posted

May 6, 2023

Last verified

May, 2023

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Saskatchewan on 2023-05-06.