Actively Recruiting
Efficacy of Dietary Supplementation With Melatonin in Targeting Sleep Quality
Led by Institute of Nutrition, Slovenia (Nutris) · Updated on 2024-09-20
30
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
Sponsors
I
Institute of Nutrition, Slovenia (Nutris)
Lead Sponsor
F
Faculty of Pharmacy, University of Ljubljana, Slovenia
Collaborating Sponsor
AI-Summary
What this Trial Is About
single-center, randomized, cross over, double-blind, placebo controlled intervention study
CONDITIONS
Official Title
Efficacy of Dietary Supplementation With Melatonin in Targeting Sleep Quality
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent form
- Age between 24 and 65 years at consent
- Suboptimal sleep quality with Pittsburgh Sleep Quality Index (PSQI) score above 5
- No clinically significant insomnia with PSQI score up to 9
- Body mass index (BMI) up to 32 kg/m2
- Stable medications for allowed medical conditions for at least 6 weeks before screening
- Ability to take oral food supplements
- Willingness to attend all study visits and use actigraphy device
You will not qualify if you...
- Diagnosed sleep disorders or receiving therapy for sleep problems
- Acute infectious disease
- Use of antihypertensive or antidepressant medications
- Use of medications that may interact with study ingredients
- Pregnancy, planned pregnancy, breastfeeding, or menopause with significant symptoms
- Use of beta-blockers
- Chronic use of nonsteroidal anti-inflammatory drugs like aspirin or ibuprofen
- Use of melatonin or other sleep supplements within 2 weeks before study
- Unwillingness to avoid caffeine after 4:00 PM during the study
- Inability to wear an actigraph on an upper limb
- Known alcohol or drug abuse
- Unwillingness to limit alcohol to 2 drinks per day and 1 drink after 6:00 PM
- Known lactose or gluten intolerance or food allergies
- Known gastrointestinal diseases
- Less than 5 years since gastrointestinal cancer treatment
- History of stomach or bowel resection
- Night shift work or night work schedules
- Mental incapacity affecting understanding or cooperation
- Participation in another clinical trial
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
CMS - Center za motnje spanja
Ljubljana, Slovenia, 1000
Actively Recruiting
Research Team
I
Igor Pravst, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
3
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