Honey to Improve Sleep Quality

NCT04207281 | Unknown

• 1 other identifier: Bio-1666
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Sleep quality as measured by Leeds Sleep Evaluation Questionnaire

  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 Outcomes (3)

• Sleep quality as measured by daily sleep hygiene logs

  14 days

• Sleep quality as measured by daily morning sleep logs

  14 days

• Sleep quality as measured by actigraphy

  14 days

Study Arms (2)

Honey

ACTIVE COMPARATOR

Raw honey (1.5 tablespoons)

Dietary Supplement: Raw Honey; Dietary Supplement: Comparator

Comparator

PLACEBO COMPARATOR

Honey comparator(1.5 tablespoons)

Dietary Supplement: Raw Honey; Dietary Supplement: Comparator

Interventions

Raw Honey DIETARY_SUPPLEMENT

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

Comparator; Honey

Comparator DIETARY_SUPPLEMENT

Honey comparator(1.5 tablespoons) administered for 7 days

Comparator; Honey

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Saskatchewan: lead

Study Sites (1)

University of Saskatchewan

Saskatoon, Saskatchewan, S7N 5E5, Canada

RECRUITING

Study Officials

• Jane Alcorn, PhD

  University of Saskatchewan

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Whitney Duff, PhD

CONTACT

13069661852; whitney.duff@usask.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dean and Professor of Pharmacy and Nutrition

Study Record Dates

• First Submitted: December 18, 2019
• First Posted: December 20, 2019
• Study Start: April 1, 2021
• Primary Completion: September 1, 2024
• Study Completion: September 1, 2024
• Last Updated: May 6, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)