Efficacy of Dietary Supplementation With Melatonin in Targeting Sleep Quality

Last updated: September 18, 2024
Sponsor: Nutrition Institute, Slovenia
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

14 days of intervention with Placebo Product (PP)

14 days of intervention with Active Control (AC)

14 days of intervention with Test Product (TP)

Clinical Study ID

NCT06600633
KEP-4-6/2024-A
L7-50044
  • Ages 24-65
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

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

Eligibility Criteria

Inclusion

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): PSQIhigher than 5

  • no clinically significant (subthreshold) insomnia according to Pittsburgh SleepQuality 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 weeksprior to the screening visit

  • ability to ingest oral food supplement (study product)

  • willing to follow all study procedures, including attending all site visits and useof actigraphy

Exclusion

Exclusion criteria:

  • diagnosed or subject to therapy due to sleep disorders

  • acute infectious disease

  • any kind of chronic pharmacological therapy with antihypertensives orantidepressants

  • any kind of other pharmacological therapy that could interact with activeingredients used in the study

  • pregnancy or planned pregnancy, lactation, menopause (with clinically relevantsymptoms/therapy)

  • use of beta-blockers

  • chronic use of use of prostaglandin synthesis inhibitors (nonsteroidalanti-inflammatory drugs), such as acetylsalicylic acid and ibuprofen

  • supplementation with melatonin or other food supplements intendent for sleep qualityduring 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, andonly 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 orcolon)

  • 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 Design

Total Participants: 30
Treatment Group(s): 3
Primary Treatment: 14 days of intervention with Placebo Product (PP)
Phase:
Study Start date:
September 17, 2024
Estimated Completion Date:
September 17, 2025

Study 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.

Connect with a study center

  • CMS - Center za motnje spanja

    Ljubljana, 1000
    Slovenia

    Active - Recruiting

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