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

Study of the Efficacy of Dietary Supplementation in Targeting Sleep Quality (NutriSom Study A)

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

Study Overview

• Status: Recruiting
• Conditions: Sleep Quality; Sleep Onset Latency
• Intervention / Treatment: Dietary supplement: 14 days of intervention with Placebo Product (PP); Dietary supplement: 14 days of intervention with Active Control (AC); Dietary supplement: 14 days of intervention with Test Product (TP)

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.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Igor Pravst, PhD; Phone Number: +386 590 68871; Email: igor.pravst@nutris.org

Study Locations

• Slovenia
  • Ljubljana, Slovenia, 1000
    • Recruiting
    • CMS - Center za motnje spanja
    • Contact: Barbara Gnidovec Stražišar; Phone Number: +386 590 68 70; Email: raziskave@nutris.org
    • Principal Investigator: Barbara Gnidovec Stražišar

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: 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.	Dietary supplement: 14 days of intervention with Placebo Product (PP); 1 spray (0 mg melatonin)
Active Comparator: 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.	Dietary supplement: 14 days of intervention with Active Control (AC); 1 spray (1 mg melatonin)
Experimental: 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.	Dietary supplement: 14 days of intervention with Test Product (TP); 1 spray (0.3 mg melatonin)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in sleep onset latency (SOL) compared to placebo	Change in sleep onset latency (SOL) compared to placebo assessed by actigraphy.	last 7 days of intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changed sleep quality compared to placebo	Changed sleep quality compared to placebo - assessed by adapted Pittsburgh Sleep Quality Index (PSQI)	14 days
Changed sleep efficiency (SE) compared to placebo	Changed sleep efficiency (SE) compared to placebo - assessed by actigraphy	last 7 days of intervention

Collaborators and Investigators

• Sponsor: Nutrition Institute, Slovenia
• Collaborators: Valens Int. d.o.o., Slovenija; Faculty of Pharmacy, University of Ljubljana, Slovenia; Faculty of health sciences, Celje, Slovenia; CMS - Center za motnje spanja, Ljubljana, Slovenia
• Investigators: Study Chair: Igor Pravst, Nutrition Institute, Ljubljana; Principal Investigator: Barbara Gnidovec Stražišar, Faculty of Health Sciences in Celje, CMS - Center za motnje spanja

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): September 17, 2024
• Primary Completion (Estimated): September 17, 2025
• Study Completion (Estimated): September 17, 2025

Study Registration Dates

• First Submitted: September 12, 2024
• First Submitted That Met QC Criteria: September 16, 2024
• First Posted (Actual): September 19, 2024

Study Record Updates

• Last Update Posted (Actual): September 20, 2024
• Last Update Submitted That Met QC Criteria: September 18, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: sleep; melatonin; supplementation; sleep quality; actigraphy; sleep efficiency; sleep onset latency
• Other Study ID Numbers: KEP-4-6/2024-A; L7-50044 (Other Grant/Funding Number: Slovenian Research and Innovation Agency)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No