Efficacy of Dietary Supplementation With Melatonin in Targeting Sleep Quality

Not Applicable

Not yet recruiting

• Conditions: Sleep Onset Latency; Sleep Quality
• Interventions: 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)

• Registration Number: NCT06600633
• Lead Sponsor: Nutrition Institute, Slovenia

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.

Study Timeline

• Status Verified: 2024-09
• Study First Submitted: 2024-09-12
• Study First Submitted QC: 2024-09-16
• Last Update Submitted: 2024-09-16
• Study Start: 2024-09-17
• Study First Posted: 2024-09-19
• Last Update Posted: 2024-09-19
• Primary Completion: 2025-09-17
• Study Completion: 2025-09-17

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo product (PP)	14 days of intervention with 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.
Active control (AC)	14 days of intervention with 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.
Test product (TP)	14 days of intervention with 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.

Primary Outcome Measures

Name	Time	Method
Change in sleep onset latency (SOL) compared to placebo	last 7 days of intervention	Change in sleep onset latency (SOL) compared to placebo assessed by actigraphy.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

CMS - Center za motnje spanja; 🇸🇮 Ljubljana, Slovenia