Effect of a Botanical Ingredient in Healthy Subjects With Anxiety and Poor Sleep Quality (Q-Sleep)

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.

Study Overview

• Status: Completed
• Conditions: Poor Quality Sleep
• Intervention / Treatment: Dietary supplement: Botanical ingredient; Dietary supplement: Control group

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.

• Study Type: Interventional
• Enrollment (Actual): 79
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Murcia, Spain, 30107
    • Catholic University of Murcia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Botanical ingredient; 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
Placebo Comparator: Control Group; 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

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
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
Body composition	It is a control variable. Measured by bioimpedance	The test will be measured at baseline and after 12 weeks of consumption.
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.
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.
Anxiety questionnaire	Test STAI, to measure the level of anxiety of the subjects	Day 1, at 12 weeks later
Adverse events	It will be evaluated at each of the visits.	At 12 weeks after consumption
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).
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
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).

Collaborators and Investigators

• Sponsor: Universidad Católica San Antonio de Murcia

Study record dates

Study Major Dates

• Study Start (Actual): September 15, 2023
• Primary Completion (Actual): December 22, 2023
• Study Completion (Actual): January 29, 2024

Study Registration Dates

• First Submitted: November 23, 2023
• First Submitted That Met QC Criteria: December 1, 2023
• First Posted (Actual): December 4, 2023

Study Record Updates

• Last Update Posted (Actual): February 16, 2024
• Last Update Submitted That Met QC Criteria: February 15, 2024
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: botanic extract
• Other Study ID Numbers: UCAMCFE-00034

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No