Study of the Efficacy of Dietary Supplementation in Targeting Sleep Quality (NutriSom Study A)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Change in sleep onset latency (SOL) compared to placebo
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 24 Years to 65 Years (Adult, Older Adult)
- Sex
- 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
- •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
Arms & Interventions
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.
Intervention: 14 days of intervention with Placebo Product (PP) (Dietary Supplement)
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.
Intervention: 14 days of intervention with Active Control (AC) (Dietary Supplement)
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.
Intervention: 14 days of intervention with Test Product (TP) (Dietary Supplement)
Outcomes
Primary Outcomes
Change in sleep onset latency (SOL) compared to placebo
Time Frame: last 7 days of intervention
Change in sleep onset latency (SOL) compared to placebo assessed by actigraphy.
Secondary Outcomes
- Changed sleep quality compared to placebo(14 days)
- Changed sleep efficiency (SE) compared to placebo(last 7 days of intervention)
Investigators
Igor Pravst
Prof. Dr. Igor Pravst
Nutrition Institute, Slovenia