Efficacy of Different Types of Milk in Improving Sleep Quality in Subjects With Sleep Problems (Milca)
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Placebo Comparator: Control Subjects will consume 250 ml of milk half an hour before bedtime. |
Dietary Supplement: Control Product
Lactose-free skimmed milk
|
| Experimental: Ashw 250 Subjects will consume 250 ml of milk half an hour before bedtime. |
Dietary Supplement: Experimental Product: 250
Lactose-free skimmed milk enriched with 250 mg aswaghanda
|
| Experimental: Ashw 250 + TRP Subjects will consume 250 ml of milk half an hour before bedtime. |
Dietary Supplement: Experimental Product: 250 + TRP
Lactose-free skimmed milk enriched with 250 mg aswaghanda and tryptophan
|
| Experimental: Ashw 600 Subjects will consume 250 ml of milk half an hour before bedtime. |
Dietary Supplement: Experimental Product: 600
Lactose-free skimmed milk enriched with 600 mg aswaghanda
|
Outcome Measures
Primary Outcome Measures
- 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
- 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
- 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
- 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
- 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
- Adverse events [At 12 weeks after consumption]
It will be evaluated at each of the visits.
Eligibility Criteria
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).
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Catholic University of Murcia | Murcia | Spain | 30107 |
Sponsors and Collaborators
- Universidad Católica San Antonio de Murcia
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- UCAMCFE-00033