Efficacy of Dietary Supplementation With Melatonin in Targeting Sleep Quality

NCT ID: NCT06600633

Last Updated: 2024-09-20

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-17
• Study Completion Date: 2025-09-17

Brief Summary

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

Detailed 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.

Conditions

Sleep Onset Latency; Sleep Quality

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Placebo product (PP)

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

Group Type: PLACEBO_COMPARATOR

14 days of intervention with Placebo Product (PP)

Intervention Type: DIETARY_SUPPLEMENT

1 spray (0 mg melatonin)

Active control (AC)

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.

Group Type: ACTIVE_COMPARATOR

14 days of intervention with Active Control (AC)

Intervention Type: DIETARY_SUPPLEMENT

1 spray (1 mg melatonin)

Test product (TP)

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.

Group Type: EXPERIMENTAL

14 days of intervention with Test Product (TP)

Intervention Type: DIETARY_SUPPLEMENT

1 spray (0.3 mg melatonin)

Interventions

14 days of intervention with Placebo Product (PP)

1 spray (0 mg melatonin)

Intervention Type: DIETARY_SUPPLEMENT

14 days of intervention with Active Control (AC)

1 spray (1 mg melatonin)

Intervention Type: DIETARY_SUPPLEMENT

14 days of intervention with Test Product (TP)

1 spray (0.3 mg melatonin)

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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

• Minimum Eligible Age: 24 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Faculty of Pharmacy, University of Ljubljana, Slovenia

UNKNOWN

Sponsor Role: collaborator

Faculty of health sciences, Celje, Slovenia

UNKNOWN

Sponsor Role: collaborator

CMS - Center za motnje spanja, Ljubljana, Slovenia

UNKNOWN

Sponsor Role: collaborator

Valens Int. d.o.o., Slovenija

INDUSTRY

Sponsor Role: collaborator

Institute of Nutrition, Slovenia (Nutris)

OTHER

Sponsor Role: lead

Responsible Party

Igor Pravst

Prof. Dr. Igor Pravst

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Igor Pravst

Role: STUDY_CHAIR

Nutrition Institute, Ljubljana

Barbara Gnidovec Stražišar

Role: PRINCIPAL_INVESTIGATOR

Faculty of Health Sciences in Celje, CMS - Center za motnje spanja

Locations

CMS - Center za motnje spanja

Ljubljana, , Slovenia

Site Status: RECRUITING

Countries

Slovenia

Central Contacts

Igor Pravst, PhD

Role: CONTACT

igor.pravst@nutris.org

+386 590 68871

Facility Contacts

Barbara Gnidovec Stražišar

Role: primary

raziskave@nutris.org

+386 590 68 70

Related Links

https://nutris.org/en/projects/nutrisom

NutriSom project webpage: Efficacy and safety of dietary supplementation in targeting sleep quality (L7-50044)

Other Identifiers

L7-50044

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

KEP-4-6/2024-A

Identifier Type: -

Identifier Source: org_study_id