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

NCT ID: NCT06154629

Last Updated: 2024-02-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 79 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-15
• Study Completion Date: 2024-01-29

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.

Conditions

Poor Quality Sleep

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: QUADRUPLE

Study Groups

Botanical ingredient

Consumption for 90 days. Subjects should consume one capsule one hour before going to sleep

Group Type: EXPERIMENTAL

Botanical ingredient

Intervention Type: DIETARY_SUPPLEMENT

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

Group Type: PLACEBO_COMPARATOR

Control group

Intervention Type: DIETARY_SUPPLEMENT

Consumption for 90 days. Subjects should consume one capsule one hour before going to sleep

Interventions

Botanical ingredient

Consumption for 90 days. Subjects should consume one capsule one hour before going to sleep

Intervention Type: DIETARY_SUPPLEMENT

Control group

Consumption for 90 days. Subjects should consume one capsule one hour before going to sleep

Intervention Type: DIETARY_SUPPLEMENT

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Universidad Católica San Antonio de Murcia

OTHER

Sponsor Role: lead

Responsible Party

Francisco Javier López Román

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Catholic University of Murcia

Murcia, , Spain

Countries

Spain

Other Identifiers

UCAMCFE-00034

Identifier Type: -

Identifier Source: org_study_id