Efficacy of Different Types of Milk in Improving Sleep Quality in Subjects With Sleep Problems (Milca)
NCT ID: NCT06154616
Last Updated: 2024-02-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
52 participants
INTERVENTIONAL
2023-09-15
2024-01-19
Brief Summary
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Detailed Description
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They will make a total of two visits to the research laboratory and the tests preestablished in the protocol will be performed. Subsequently, a statistical analysis will be performed with the variables measured in the study to obtain the results.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
QUADRUPLE
Study Groups
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Control
Subjects will consume 250 ml of milk half an hour before bedtime.
Control Product
Lactose-free skimmed milk
Ashw 250
Subjects will consume 250 ml of milk half an hour before bedtime.
Experimental Product: 250
Lactose-free skimmed milk enriched with 250 mg aswaghanda
Ashw 250 + TRP
Subjects will consume 250 ml of milk half an hour before bedtime.
Experimental Product: 250 + TRP
Lactose-free skimmed milk enriched with 250 mg aswaghanda and tryptophan
Ashw 600
Subjects will consume 250 ml of milk half an hour before bedtime.
Experimental Product: 600
Lactose-free skimmed milk enriched with 600 mg aswaghanda
Interventions
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Control Product
Lactose-free skimmed milk
Experimental Product: 250
Lactose-free skimmed milk enriched with 250 mg aswaghanda
Experimental Product: 250 + TRP
Lactose-free skimmed milk enriched with 250 mg aswaghanda and tryptophan
Experimental Product: 600
Lactose-free skimmed milk enriched with 600 mg aswaghanda
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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).
18 Years
65 Years
ALL
Yes
Sponsors
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Universidad Católica San Antonio de Murcia
OTHER
Responsible Party
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Francisco Javier López Román
Principal Investigator
Locations
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Catholic University of Murcia
Murcia, , Spain
Countries
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Other Identifiers
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UCAMCFE-00033
Identifier Type: -
Identifier Source: org_study_id
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