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

NCT06154629 | Completed DMC

• 1 other identifier: UCAMCFE-00034
• Study Type: interventional
• Target: 79
• Locations: 1 country
• Sites: 1

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.

Conditions

Poor Quality Sleep

Keywords

botanic extract

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

• Change in Sleep Quality from baseline at 12 weeks

  Sleep quality will be measured with a daily scale, from baseline to 12 weeks.

• Sleep quality

  It will be measured twice, once at baseline or at the end of the study after 12 weeks of use

• Sleep efficiency

  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

  Day 1, at 12 weeks later

• Perceived stress scale

  Day 1, at 12 weeks later

Study Arms (2)

Botanical ingredient

EXPERIMENTAL

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

Dietary Supplement: Botanical ingredient

Control Group

PLACEBO COMPARATOR

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

Dietary Supplement: Control group

Interventions

Botanical ingredient DIETARY_SUPPLEMENT

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

Botanical ingredient

Control group DIETARY_SUPPLEMENT

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

Control Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad Católica San Antonio de Murcia: lead

Study Sites (1)

Catholic University of Murcia

Murcia, 30107, Spain

Location

MeSH Terms

Interventions

Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 23, 2023
• First Posted: December 4, 2023
• Study Start: September 15, 2023
• Primary Completion: December 22, 2023
• Study Completion: January 29, 2024
• Last Updated: February 16, 2024

Record last verified: 2023-09

Locations

ES (1)