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Honey to Improve Sleep Quality: a Feasibility Study

NCT03567395 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2019-04-30

No results posted yet for this study

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.

Conditions

  • Poor Quality Sleep

Interventions

DIETARY_SUPPLEMENT

Melatonin

Melatonin (5 mg sublingual tablet) administered for 3 days

DIETARY_SUPPLEMENT

Honey

Raw Honey (1.5 tablespoons) administered for 3 days

Sponsors & Collaborators

  • University of Saskatchewan

    lead OTHER

Principal Investigators

  • Jane Alcorn, PhD · University of Saskatchewan

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-04-18
Primary Completion
2018-09-30
Completion
2018-12-15

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03567395 on ClinicalTrials.gov