Efficacy of Dietary Supplementation With Melatonin in Targeting Sleep Quality

Recruiting now · Not applicable · Has a placebo group

Conditions studied: Sleep Onset Latency, Sleep Quality

In brief

single-center, randomized, cross over, double-blind, placebo controlled intervention study

Key facts

Study ID

NCT06600633

Run by

Institute of Nutrition, Slovenia (Nutris)

People needed

30

Starts

2024-09-17

Expected to finish

2025-09-17

Last updated by the study team

2024-09-20

Who can join

Age: 24 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• subject Informed consent form (ICF) is signed
• aged 24-65 years at the time of the signature of ICF
• suboptimal sleep quality according to Pittsburgh Sleep Quality Index (PSQI-SI): PSQI higher than 5
• no clinically significant (subthreshold) insomnia according to Pittsburgh Sleep Quality Index (PSQI-SI) (Kmetec et al., 2022): PSQI up to 9
• a body mass index (BMI) up to 32 kg/m2
• stable medications for non excluded concurrent medical conditions for six weeks prior to the screening visit
• ability to ingest oral food supplement (study product)
• willing to follow all study procedures, including attending all site visits and use of actigraphy

You may not qualify if…

• diagnosed or subject to therapy due to sleep disorders
• acute infectious disease
• any kind of chronic pharmacological therapy with antihypertensives or antidepressants
• any kind of other pharmacological therapy that could interact with active ingredients used in the study
• pregnancy or planned pregnancy, lactation, menopause (with clinically relevant symptoms/therapy)
• use of beta-blockers
• chronic use of use of prostaglandin synthesis inhibitors (nonsteroidal anti-inflammatory drugs), such as acetylsalicylic acid and ibuprofen
• supplementation with melatonin or other food supplements intendent for sleep quality during last 2 weeks
• unwillingness to maintain caffeine abstinence after 4:00 PM during the study
• not having a mobile upper extremity for attaching an actigraph
• known alcohol and/or drug abuse
• unwillingness to comply with the maximum limit of 2 alcoholic drinks per day, and only up to 1 alcoholic drink after 6:00 PM during the study
• known lactose/gluten intolerances/food allergies
• known gastrointestinal disease
• less than 5 years after treatment for gastrointestinal cancer (stomach, duodenum or colon)
• have stomach or bowel resection
• night work (including as part of shift work)
• mental incapacity that precludes adequate understanding or cooperation
• participation in another investigational study

Where it is running

• CMS - Center za motnje spanja — Ljubljana, Slovenia (enrolling)

Full record on ClinicalTrials.gov

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