Clinical trial NCT06154629: Effect of a Botanical Ingredient in Healthy Subjects With Anxiety and Poor Sleep Quality
Official title: Effect of a Botanical Ingredient in Healthy Subjects With Anxiety and Poor Sleep Quality
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Poor Quality Sleep
Keywords: botanic extract
Lead sponsor: Universidad Católica San Antonio de Murcia
Sponsor class: OTHER
First posted: 2023-12-04
Enrollment: 79
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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.

Primary outcomes:
measure: Variation in sleep quality from baseline at 12 weeks.
timeFrame: The evolution of sleep quality after consumption during 12 weeks will be measured.
Secondary outcomes:
measure: Change in Sleep Quality from baseline at 12 weeks
timeFrame: Sleep quality will be measured with a daily scale, from baseline to 12 weeks.
measure: Sleep quality
timeFrame: It will be measured twice, once at baseline or at the end of the study after 12 weeks of use
measure: Sleep efficiency
timeFrame: 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).
measure: Anxiety questionnaire
timeFrame: Day 1, at 12 weeks later
measure: Perceived stress scale
timeFrame: Day 1, at 12 weeks later
measure: Melatonine
timeFrame: It will be measured twice, once at baseline or at the end of the study after 12 weeks of use
measure: Cortisol
timeFrame: It will be measured twice, once at baseline or at the end of the study after 12 weeks of use
measure: Body composition
timeFrame: The test will be measured at baseline and after 12 weeks of consumption.
measure: Physical activity control
timeFrame: 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).
measure: Liver safety variables
timeFrame: It will be measured twice, once at baseline or at the end of the study after 12 weeks.
measure: Adverse events
timeFrame: At 12 weeks after consumption
Other outcomes:
Locations:
city: Murcia
country: Spain
facility: Catholic University of Murcia
Study officials:
References: