Efficacy of Different Types of Milk in Improving Sleep Quality in Subjects With Sleep Problems (Milca)

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Poor Quality Sleep

Intervention / Treatment
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* Dietary Supplement: Control Product
* Dietary Supplement: Experimental Product: 250
* Dietary Supplement: Experimental Product: 250 + TRP
* Dietary Supplement: Experimental Product: 600


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Control<br>Subjects will consume 250 ml of milk half an hour before bedtime. | Dietary Supplement: Control Product<br>* Lactose-free skimmed milk<br>|
| Experimental: Ashw 250<br>Subjects will consume 250 ml of milk half an hour before bedtime. | Dietary Supplement: Experimental Product: 250<br>* Lactose-free skimmed milk enriched with 250 mg aswaghanda<br>|
| Experimental: Ashw 250 + TRP<br>Subjects will consume 250 ml of milk half an hour before bedtime. | Dietary Supplement: Experimental Product: 250 + TRP<br>* Lactose-free skimmed milk enriched with 250 mg aswaghanda and tryptophan<br>|
| Experimental: Ashw 600<br>Subjects will consume 250 ml of milk half an hour before bedtime. | Dietary Supplement: Experimental Product: 600<br>* Lactose-free skimmed milk enriched with 600 mg aswaghanda<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Variation in sleep quality from baseline at 12 weeks. | Visual analog scale from 0 to 10. The higher the value, the more quality. | The evolution of sleep quality after consumption during 12 weeks will be measured. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Sleep Quality from baseline at 12 weeks | Visual analog scale from 0 to 10. The higher the value, the more quality. | Sleep quality will be measured with a daily scale, from baseline to 12 weeks. | 
| Sleep quality | Measured by Pittsburgh test | It will be measured twice, once at baseline or at the end of the study after 12 weeks of use | 
| Insomnia severity | Measured by Insomnia severity index - ISI test | It will be measured twice, once at baseline or at the end of the study after 12 weeks of use | 
| Sleepiness | Measured by Epworth test | It will be measured twice, once at baseline or at the end of the study after 12 weeks of use | 
| Matutinity - Verpertinity | Measured by Matutinity - Verpertinity questionnaire | It will be measured twice, once at baseline or at the end of the study after 12 weeks of use | 
| Anxiety questionnaire | Test STAI, to measure the level of anxiety of the subjects | Day 1, at 12 weeks later | 
| Body composition | It is a control variable. Measured by bioimpedance | The test will be measured at baseline and after 12 weeks of consumption. | 
| Adverse events | It will be evaluated at each of the visits. | At 12 weeks after consumption | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ashwagandha extract, tryptophan