Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | Placebo Comparator | Subjects will consume 250 ml of milk half an hour before bedtime. |
|
| Ashw 250 | Experimental | Subjects will consume 250 ml of milk half an hour before bedtime. |
|
| Ashw 250 + TRP | Experimental | Subjects will consume 250 ml of milk half an hour before bedtime. |
|
| Ashw 600 | Experimental | Subjects will consume 250 ml of milk half an hour before bedtime. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Control Product | Dietary Supplement | Lactose-free skimmed milk |
| |
| 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. |
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Catholic University of Murcia | Murcia | 30107 | Spain |
Not provided
Not provided
Not provided
Not provided
Not provided
| Experimental Product: 250 |
| Dietary Supplement |
Lactose-free skimmed milk enriched with 250 mg aswaghanda |
|
| Experimental Product: 250 + TRP | Dietary Supplement | Lactose-free skimmed milk enriched with 250 mg aswaghanda and tryptophan |
|
| Experimental Product: 600 | Dietary Supplement | Lactose-free skimmed milk enriched with 600 mg aswaghanda |
|
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 |
| ID | Term |
|---|---|
| D035061 | Control Groups |
| C000606701 | tryptophyltryptophan |
| ID | Term |
|---|---|
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
| D008722 | Methods |
Not provided
Not provided