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

Poor Quality Sleep Clinical Trial

— Q-Sleep  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06154629
• Other study ID #: UCAMCFE-00034
• Status: Completed
• Phase: N/A
• Start date: September 15, 2023
• Est. completion date: January 29, 2024

Study information

• Verified date: September 2023
• Source: Universidad Católica San Antonio de Murcia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 79
• Est. completion date: January 29, 2024
• Est. primary completion date: December 22, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Poor Quality Sleep

Intervention

Dietary Supplement:
• Botanical ingredient
Consumption for 90 days. Subjects should consume one capsule one hour before going to sleep
• Control group
Consumption for 90 days. Subjects should consume one capsule one hour before going to sleep

Locations

Country	Name	City	State
Spain	Catholic University of Murcia	Murcia

Sponsors (1)

Lead Sponsor	Collaborator
Universidad Católica San Antonio de Murcia

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	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
Secondary	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).
Secondary	Anxiety questionnaire	Test STAI, to measure the level of anxiety of the subjects	Day 1, at 12 weeks later
Secondary	Perceived stress scale	Scale Remor, 2001. Test to measure the level of stress of the subjects	Day 1, at 12 weeks later
Secondary	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
Secondary	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
Secondary	Body composition	It is a control variable. Measured by bioimpedance	The test will be measured at baseline and after 12 weeks of consumption.
Secondary	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).
Secondary	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.
Secondary	Adverse events	It will be evaluated at each of the visits.	At 12 weeks after consumption