Status:
COMPLETED
Efficacy of Different Types of Milk in Improving Sleep Quality in Subjects With Sleep Problems (Milca)
Lead Sponsor:
Universidad Católica San Antonio de Murcia
Conditions:
Poor Quality Sleep
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
Randomized, controlled, double-blind intervention study, with four parallel branches depending on the product consumed, to analyze the efficacy of different types of milks on the improvement of sleep ...
Detailed Description
The duration of the study will be 90 days (12 weeks). Each day they will have to consume the product under investigation. The subjects who meet the selection criteria will be randomly distributed in e...
Eligibility Criteria
Inclusion
- Healthy adults (\> 18 years).
- Low sleep quality by Pittsburgh Sleep Quality Questionnaire (PSQI).
- Volunteers able to understand the clinical study and willing to comply with the study procedures and requirements.
Exclusion
- Subjects with serious or terminal illnesses.
- Subjects with known allergy or hypersensitivity to any of the components of the investigational product.
- Participation in another study involving blood draws or dietary intervention.
- Subjects with body mass index above 32 kg/m2.
- Pregnant or lactating women.
- Use of medications that alter cognitive functions or sleep, such as barbiturates, anticonvulsants, benzodiazepines, antidepressants, neuroleptics, alcohol and illicit drugs.
- Organic dementias such as Alzheimer's, Huntington's disease, Parkinson's and senile dementia.
- Inability to understand informed consent (IC).
Key Trial Info
Start Date :
September 15 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 19 2024
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT06154616
Start Date
September 15 2023
End Date
January 19 2024
Last Update
February 16 2024
Active Locations (1)
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1
Catholic University of Murcia
Murcia, Spain, 30107