An interventional study of Botanical ingredient and Control group 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, 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.
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.
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:
Consumption for 90 days. Subjects should consume one capsule one hour before going to sleep
Dietary Supplement: Botanical ingredient
Consumption for 90 days. Subjects should consume one capsule one hour before going to sleep
Dietary Supplement: Control group
Consumption for 90 days. Subjects should consume one capsule one hour before going to sleep
Consumption for 90 days. Subjects should consume one capsule one hour before going to sleep
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
Sleep efficiency
Measured by accelerometry, with Actigraph wGT3X-BT
Time frame: 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
Time frame: Day 1, at 12 weeks later
Perceived stress scale
Scale Remor, 2001. Test to measure the level of stress of the subjects
Time frame: Day 1, at 12 weeks later
Melatonine
It is measured with a blood sample in the early evening.
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 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.
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