Clinical Trials Directory

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UnknownNCT04207281

Honey to Improve Sleep Quality

Honey to Improve Sleep Quality: a Randomized, Double-blind Trial

Status
Unknown
Phase
N/A
Study type
Interventional
Enrollment
110 (estimated)
Sponsor
University of Saskatchewan · Academic / Other
Sex
All
Age
18 Years – 55 Years
Healthy volunteers
Accepted

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.

Conditions

Interventions

TypeNameDescription
DIETARY_SUPPLEMENTRaw HoneyCanada #2 white raw honey (1.5 tablespoons) supplied by SweetHeart Pollinators (Janeil Enterprises, Eatonia, SK) administered for 7 days
DIETARY_SUPPLEMENTComparatorHoney comparator(1.5 tablespoons) administered for 7 days

Timeline

Start date
2021-04-01
Primary completion
2024-09-01
Completion
2024-09-01
First posted
2019-12-20
Last updated
2023-05-06

Locations

1 site across 1 country: Canada

Source: ClinicalTrials.gov record NCT04207281. Inclusion in this directory is not an endorsement.