Effect of a Botanical Ingredient in Healthy Subjects With Anxiety and Poor Sleep Quality

Study Overview
=================
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.

Official Title
-----------------
Effect of a Botanical Ingredient in Healthy Subjects With Anxiety and Poor Sleep Quality

Conditions
-----------------
Poor Quality Sleep

Intervention / Treatment
-----------------
* Dietary Supplement: Botanical ingredient
* Dietary Supplement: Control group


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Botanical ingredient<br>Consumption for 90 days. Subjects should consume one capsule one hour before going to sleep | Dietary Supplement: Botanical ingredient<br>* Consumption for 90 days. Subjects should consume one capsule one hour before going to sleep<br>|
| Placebo Comparator: Control Group<br>Consumption for 90 days. Subjects should consume one capsule one hour before going to sleep | Dietary Supplement: Control group<br>* Consumption for 90 days. Subjects should consume one capsule one hour before going to sleep<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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. | 

Secondary Outcome Measures

| Outcome Measure | 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 | Measured by Pittsburgh test | It will be measured twice, once at baseline or at the end of the study after 12 weeks of use | 
| Sleep efficiency | Measured by accelerometry, with Actigraph wGT3X-BT | 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). | 
| Anxiety questionnaire | Test STAI, to measure the level of anxiety of the subjects | Day 1, at 12 weeks later | 
| Perceived stress scale | Scale Remor, 2001. Test to measure the level of stress of the subjects | Day 1, at 12 weeks later | 
| Melatonine | It is measured with a blood sample in the early evening. | It will be measured twice, once at baseline or at the end of the study after 12 weeks of use | 
| Cortisol | Measured with blood sample first thing in the morning. | It will be measured twice, once at baseline or at the end of the study after 12 weeks of use | 
| Body composition | It is a control variable. Measured by bioimpedance | The test will be measured at baseline and after 12 weeks of consumption. | 
| Physical activity control | It is a control variable. Measured by Actigraph wGT3X-BT | 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). | 
| Liver safety variables | 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) | It will be measured twice, once at baseline or at the end of the study after 12 weeks. | 
| Adverse events | It will be evaluated at each of the visits. | At 12 weeks after consumption | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
botanic extract