Efficacy of Different Types of Milk in Improving Sleep Quality in Subjects With Sleep Problems (Milca)
- Conditions
- Poor Quality Sleep
- Interventions
- Dietary Supplement: Control Product
- Registration Number
- NCT06154616
- Lead Sponsor
- Universidad Católica San Antonio de Murcia
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 52
- 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.
- 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).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Control Control Product Subjects will consume 250 ml of milk half an hour before bedtime.
- Primary Outcome Measures
Name Time Method Variation in sleep quality from baseline at 12 weeks. The evolution of sleep quality after consumption during 12 weeks will be measured. Visual analog scale from 0 to 10. The higher the value, the more quality.
- Secondary Outcome Measures
Name Time Method Change in Sleep Quality from baseline at 12 weeks Sleep quality will be measured with a daily scale, from baseline to 12 weeks. Visual analog scale from 0 to 10. The higher the value, the more quality.
Sleep quality It will be measured twice, once at baseline or at the end of the study after 12 weeks of use Measured by Pittsburgh test
Anxiety questionnaire Day 1, at 12 weeks later Test STAI, to measure the level of anxiety of the subjects
Body composition The test will be measured at baseline and after 12 weeks of consumption. It is a control variable. Measured by bioimpedance
Sleepiness It will be measured twice, once at baseline or at the end of the study after 12 weeks of use Measured by Epworth test
Matutinity - Verpertinity It will be measured twice, once at baseline or at the end of the study after 12 weeks of use Measured by Matutinity - Verpertinity questionnaire
Insomnia severity It will be measured twice, once at baseline or at the end of the study after 12 weeks of use Measured by Insomnia severity index - ISI test
Adverse events At 12 weeks after consumption It will be evaluated at each of the visits.
Trial Locations
- Locations (1)
Catholic University of Murcia
🇪🇸Murcia, Spain