Poor Quality Sleep
Conditions
Keywords
botanic extract
Brief summary
Randomized, controlled, double-blind, single-center clinical trial with two parallel arms depending on the product consumed (experimental product and placebo product) to analyze the efficacy of a botanical extract in reducing anxiety and improving sleep quality.
Detailed description
Subjects who meet the selection criteria will be randomly assigned to each of the study groups (investigational product dose or placebo, depending on the group to which they have been assigned). The product to be consumed is a botanical extract. Participants will consume the product for 90 days. They should consume one capsule one hour before going to sleep. They will make a total of five 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_SUPPLEMENTBotanical ingredient
Consumption for 90 days. Subjects should consume one capsule one hour before going to sleep
DIETARY_SUPPLEMENTControl group
Consumption for 90 days. Subjects should consume one capsule one hour before going to sleep
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. * Moderate levels of anxiety by STAI. * Low sleep quality by PSQI. * Volunteers able to understand the clinical study and willing to comply with its procedures and requirements.
Exclusion criteria
* Serious or terminal illness. * Subjects with body mass index above 32 kg/m2. Pregnant or lactating women. * Participation in another study involving blood draws or dietary intervention. * Organic dementias such as Alzheimer's, Huntington's disease, Parkinson's and senile dementia. * Hypersensitivity to the components of the formula. * Use of medications that alter cognitive functions or sleep, such as barbiturates, anticonvulsants, benzodiazepines, antidepressants, neuroleptics, alcohol and illicit drugs. * Subjects with known allergy to some of the study components. * Inability to understand the informed consent.
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 |
| Sleep efficiency | It will be measured during 4 working days and one weekend day, before starting the consumption of the product and before the end of consumption (90 days). | Measured by accelerometry, with Actigraph wGT3X-BT |
| Anxiety questionnaire | Day 1, at 12 weeks later | Test STAI, to measure the level of anxiety of the subjects |
| Perceived stress scale | Day 1, at 12 weeks later | Scale Remor, 2001. Test to measure the level of stress of the subjects |
| Melatonine | It will be measured twice, once at baseline or at the end of the study after 12 weeks of use | It is measured with a blood sample in the early evening. |
| 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. |
| Body composition | The test will be measured at baseline and after 12 weeks of consumption. | It is a control variable. Measured by bioimpedance |
| Physical activity control | It will be measured during 4 working days and one weekend day, before starting the consumption of the product and before the end of consumption (90 days). | It is a control variable. Measured by Actigraph wGT3X-BT |
| Liver safety variables | It will be measured twice, once at baseline or at the end of the study after 12 weeks. | It is a blood test that measures the presence of some enzymes, proteins and bilirubin in the blood, with the aim of determining if there is any alteration in the liver. Enzyme GPT, GOT, Gamma GT, LDH, alkaline phosphatase and bilirubin (UI/L) |
| Adverse events | At 12 weeks after consumption | It will be evaluated at each of the visits. |
| Cortisol | It will be measured twice, once at baseline or at the end of the study after 12 weeks of use | Measured with blood sample first thing in the morning. |
Countries
Spain
Outcome results
None listed