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RecruitingNCT06600633NutriSom-01AUpdated Sep 20, 2024

Efficacy of Dietary Supplementation With Melatonin in Targeting Sleep Quality

An interventional study of 14 days of intervention with Placebo Product (PP) and 14 days of intervention with Active Control (AC) in Sleep Onset Latency and Sleep Quality, sponsored by Nutrition Institute, Slovenia. Recruiting at 1 site in Slovenia. Open to participants aged 24 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-09-20.

Sponsored by Nutrition Institute, Slovenia · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
24 Years to 65 Years
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Sleep Onset Latency
  • Sleep Quality

Keywords

  • melatonin
  • supplementation
  • sleep
  • sleep onset latency
  • actigraphy
  • sleep quality
  • sleep efficiency
03

Who can participate

Ages eligible
24 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
30 participants (estimated)

Study arms

  • 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)

  • 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)

  • 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)

Interventions

  • Dietary supplement14 days of intervention with Placebo Product (PP)

    1 spray (0 mg melatonin)

  • Dietary supplement14 days of intervention with Active Control (AC)

    1 spray (1 mg melatonin)

  • Dietary supplement14 days of intervention with Test Product (TP)

    1 spray (0.3 mg melatonin)

05

What researchers measure

Primary outcomes

  1. Change in sleep onset latency (SOL) compared to placebo

    Change in sleep onset latency (SOL) compared to placebo assessed by actigraphy.

    Time frame: last 7 days of intervention

Secondary outcomes

  1. Changed sleep quality compared to placebo

    Changed sleep quality compared to placebo - assessed by adapted Pittsburgh Sleep Quality Index (PSQI)

    Time frame: 14 days

  2. Changed sleep efficiency (SE) compared to placebo

    Changed sleep efficiency (SE) compared to placebo - assessed by actigraphy

    Time frame: last 7 days of intervention

06

Study locations

1 of 1 sites recruiting
  • CMS - Center za motnje spanja
    Ljubljana, 1000, Slovenia
    • Barbara Gnidovec Stražišar · Contact · raziskave@nutris.org · +386 590 68 70
    • Barbara Gnidovec Stražišar · Principal investigator
    Recruiting
07

References and documents

Individual participant data

Plan to share: Undecided

08

Registry details

Key details

Study ID
NCT06600633
Lead sponsor
Nutrition Institute, Slovenia
Collaborators
Faculty of Pharmacy, University of Ljubljana, Slovenia, Faculty of health sciences, Celje, Slovenia, CMS - Center za motnje spanja, Ljubljana, Slovenia, Valens Int. d.o.o., Slovenija
Responsible party
Igor Pravst (Prof. Dr. Igor Pravst, Nutrition Institute, Slovenia) — Principal investigator
First posted
Sep 19, 2024
Start date
Sep 17, 2024
Primary completion
Sep 17, 2025 (estimated)
Completion
Sep 17, 2025 (estimated)
Last update
Sep 20, 2024

Study contacts

Igor Pravst, PhD
Contact
igor.pravst@nutris.org
+386 590 68871
Igor Pravst
study chair · Nutrition Institute, Ljubljana
Barbara Gnidovec Stražišar
principal investigator · Faculty of Health Sciences in Celje, CMS - Center za motnje spanja

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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