Efficacy of Dietary Supplementation With Melatonin in Targeting Sleep Quality (NutriSom-01A)

Nutrition Institute, Slovenia

Status: Enrolling

Conditions: Sleep Onset Latency; Sleep Quality

Treatments: Dietary Supplement: 14 days of intervention with Active Control (AC); Dietary Supplement: 14 days of intervention with Test Product (TP); Dietary Supplement: 14 days of intervention with Placebo Product (PP)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06600633

L7-50044 (Other Grant/Funding Number)

KEP-4-6/2024-A

Details and patient eligibility

About

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

Full description

The single-center, randomized, cross over, double-blind, placebo controlled intervention study will include 30 subjects who will test the efficacy of three formulations with different dosages of melatonin on sleep quality parameters.

Enrollment: 30 estimated patients

Sex: All

Ages: 24 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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30 participants in 3 patient groups, including a placebo group

Placebo product (PP)

Placebo Comparator group

Description:

Active ingredient: none Instructions for use: Supplement should be consumed once per day during the intervention period, about one hour to bedtime.

Treatment:

Dietary Supplement: 14 days of intervention with Placebo Product (PP)

Active control (AC)

Active Comparator group

Description:

Active ingredient: 1 mg of melatonin per dosage Instructions for use: Supplement should be consumed once per day during the intervention period, about one hour to bedtime.

Treatment:

Dietary Supplement: 14 days of intervention with Active Control (AC)

Test product (TP)

Experimental group

Description:

Active ingredient: 0.3 mg of melatonin per dossage Instructions for use: Supplement should be consumed once per day during the intervention period, about one hour to bedtime.

Treatment:

Dietary Supplement: 14 days of intervention with Test Product (TP)