Last updated: May 3, 2023
Sponsor: University of Saskatchewan
Overall Status: Active - Recruiting
Phase
N/A
Condition
N/ATreatment
Raw Honey
Comparator
Clinical Study ID
NCT04207281
Bio-1666
Ages 18-55 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
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 vasculardisease, 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
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 injectablecorticosteroid, 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 onemonth prior to randomization
Study Design
Total Participants: 110
Treatment Group(s): 2
Primary Treatment: Raw Honey
Phase:
Study Start date:
April 01, 2021
Estimated Completion Date:
September 01, 2024
Study Description
Connect with a study center
University of Saskatchewan
Saskatoon, Saskatchewan S7N 5E5
CanadaActive - Recruiting
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