An interventional study of Control Product and Experimental Product: 250 in Poor Quality Sleep, sponsored by Universidad Católica San Antonio de Murcia. Completed at 1 site in Spain. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-02-16.
Sponsored by Universidad Católica San Antonio de Murcia · Not applicable, Interventional, and Other
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.
324 studies on the registry are indexed under Dyssomnias; 51 are open to participants now.
This study's enrollment of 52 is below the median of 60 across 251 interventional studies indexed under Dyssomnias.
Browse Dyssomnias studies →Universidad Católica San Antonio de Murcia is the lead sponsor of 132 studies on the registry; 18 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Subjects will consume 250 ml of milk half an hour before bedtime.
Dietary Supplement: Control Product
Subjects will consume 250 ml of milk half an hour before bedtime.
Dietary Supplement: Experimental Product: 250
Subjects will consume 250 ml of milk half an hour before bedtime.
Dietary Supplement: Experimental Product: 250 + TRP
Subjects will consume 250 ml of milk half an hour before bedtime.
Dietary Supplement: Experimental Product: 600
Lactose-free skimmed milk
Lactose-free skimmed milk enriched with 250 mg aswaghanda
Lactose-free skimmed milk enriched with 250 mg aswaghanda and tryptophan
Lactose-free skimmed milk enriched with 600 mg aswaghanda
Variation in sleep quality from baseline at 12 weeks.
Visual analog scale from 0 to 10. The higher the value, the more quality.
Time frame: The evolution of sleep quality after consumption during 12 weeks will be measured.
Change in Sleep Quality from baseline at 12 weeks
Visual analog scale from 0 to 10. The higher the value, the more quality.
Time frame: Sleep quality will be measured with a daily scale, from baseline to 12 weeks.
Sleep quality
Measured by Pittsburgh test
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Day 1, at 12 weeks later
Body composition
It is a control variable. Measured by bioimpedance
Time frame: The test will be measured at baseline and after 12 weeks of consumption.
Adverse events
It will be evaluated at each of the visits.
Time frame: At 12 weeks after consumption
This study is completed, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.
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Universidad Católica San Antonio de Murcia