Clinical trial NCT06154616: Efficacy of Different Types of Milk in Improving Sleep Quality in Subjects With Sleep Problems (Milca)
Official title: Analysis of the Efficacy of Different Types of Milk Enriched With Tryptophan and Supplemented With Ashwagandha Extract in Improving Sleep Quality in Subjects With Sleep Problems
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Poor Quality Sleep
Keywords: Ashwagandha extract
tryptophan
Lead sponsor: Universidad Católica San Antonio de Murcia
Sponsor class: OTHER
First posted: 2023-12-04
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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 quality.

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 each of the study groups (A, B, C or D, depending on the group in which they have been randomized). Each day the subjects will have to fill in a diary on sleep quality and concomitant medication.

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.

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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).

Primary outcomes:
measure: Variation in sleep quality from baseline at 12 weeks.
timeFrame: The evolution of sleep quality after consumption during 12 weeks will be measured.
Secondary outcomes:
measure: Change in Sleep Quality from baseline at 12 weeks
timeFrame: Sleep quality will be measured with a daily scale, from baseline to 12 weeks.
measure: Sleep quality
timeFrame: It will be measured twice, once at baseline or at the end of the study after 12 weeks of use
measure: Insomnia severity
timeFrame: It will be measured twice, once at baseline or at the end of the study after 12 weeks of use
measure: Sleepiness
timeFrame: It will be measured twice, once at baseline or at the end of the study after 12 weeks of use
measure: Matutinity - Verpertinity
timeFrame: It will be measured twice, once at baseline or at the end of the study after 12 weeks of use
measure: Anxiety questionnaire
timeFrame: Day 1, at 12 weeks later
measure: Body composition
timeFrame: The test will be measured at baseline and after 12 weeks of consumption.
measure: Adverse events
timeFrame: At 12 weeks after consumption
Other outcomes:
Locations:
city: Murcia
country: Spain
facility: Catholic University of Murcia
Study officials:
References: