Poor Quality Sleep
Conditions
Keywords
Ashwagandha extract, tryptophan
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.
Interventions
DIETARY_SUPPLEMENTControl Product
Lactose-free skimmed milk
DIETARY_SUPPLEMENTExperimental Product: 250
Lactose-free skimmed milk enriched with 250 mg aswaghanda
DIETARY_SUPPLEMENTExperimental Product: 250 + TRP
Lactose-free skimmed milk enriched with 250 mg aswaghanda and tryptophan
DIETARY_SUPPLEMENTExperimental Product: 600
Lactose-free skimmed milk enriched with 600 mg aswaghanda
Sponsors
Universidad Católica San Antonio de Murcia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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. |
| 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. |
| 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 |
Countries
Spain
Outcome results
None listed