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Study of the Effects of Plx on Bioparametric Measurements.

Primary Purpose

Quality of Life, Antidepressive Agents, Depression, Anxiety

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
PLX
Sponsored by
University of Alicante
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Quality of Life

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. Over 21 years of age;
  2. Without any chronic pathology;
  3. Score on the Spielberg Trait-State Anxiety Inventory (STAI-S) comprising 20 items, greater than 40 (probable clinical levels of anxiety);
  4. Pittsburgh Sleep Quality Index (PSQI) score greater than 5 (poor sleep quality).

Exclusion Criteria:

  • Failure to meet the inclusion criteria.

Sites / Locations

  • University of Alicante

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

CONTROL GROUP

PLX400mg GROUP

Arm Description

Nutraceutical placebo intake group

Intake of natural herbal dietary supplement composed of lemon verbena extract (Lippia citriodora).

Outcomes

Primary Outcome Measures

WEIGHT
The weight of the subjects will be obtained using the TANITA (Tokyo, Japan).
HEIGHT
The height of the subjects will be measured with the SECA 123 stadiometer (Hamburg, Germany).
BLOOD PREASURE
Measurement of blood pressure (systolic and diastolic) with a digital tensiometer.
FAT MASS
Assessment of body composition using the TANITA (Tokyo, Japan) validated bioimpedance scale to obtain the results of fat mass.
VISCERAL FAT
Assessment of body composition using the TANITA (Tokyo, Japan) validated bioimpedance scale to obtain the results of visceral fat.
BLOOD CORTISOL
Cortisol levels in blood by blood analysis.
SLEEP QUALITY
Measurement of sleep quality using the Pittsburgh sleep quality index.
STRESS
Measurement of perceived stress using the Perceived Stress Scale (PSS).
ANXIETY
Measurement of perceived anxiety using the Spielberger Trait-State Anxiety Inventory questionnaire; it is an instrument created with the objective of assessing anxiety in two dimensions, state and trait.
PERCEIVED QUALITY OF LIFE
Measurement of quality of life using the World Health Organization Quality of Life (WHOQOL-BREF). The WHOQOL-BREF instrument provides a profile of quality of life, with each dimension or domain being scored independently. each dimension or domain scored independently. The higher the higher the score in each domain, the better the quality of life profile of the person being the person being assessed.
HEART RATE
An electrocardiogram is used to obtain the heart rate.
SLEEP HOURS
Use of a FITBIT device to monitor the hours of sleep of each participant.

Secondary Outcome Measures

Full Information

First Posted
November 10, 2021
Last Updated
June 7, 2023
Sponsor
University of Alicante
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1. Study Identification

Unique Protocol Identification Number
NCT05128812
Brief Title
Study of the Effects of Plx on Bioparametric Measurements.
Official Title
Study of the Anxiolytic Effects, Improvement of Sleep Quality and Bioparametric Measures in Individuals Taking an Extract of Lippia Citriodora.
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
May 1, 2021 (Actual)
Primary Completion Date
July 31, 2021 (Actual)
Study Completion Date
December 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alicante

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The main objective is to study the effects of the intake of a nutraceutical on health indicators, focused on sleep and stress, as well as cardiovascular (blood pressure...), circulating (cortisol) and body composition parameters in a Spanish adult population.
Detailed Description
Anxiety is a normal part of life, and generally is a temporary condition. However, anxiety can occasionally prolong in time, having an impact on everyday activities, and give rise to other conditions, such as depression, drug abuse, cardiovascular disease, and insomnia. There are a number of synthetic drugs that are commonly used to treat anxiety. These are mainly antidepressants and benzodiazepines. However, their high cost, important side effects and a rising interest in natural solutions have driven researchers to search for botanical-based formulas. To this end, there are a number of plants that have been described to possess potential sedative and anxiolytic effects. Of note is lemon verbena (Lippia citriodora), which is native of Western South America but is also cultivated in the Mediterranean region and Middle East.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Quality of Life, Antidepressive Agents, Depression, Anxiety, Sleep Initiation and Maintenance Disorders, Body Composition, Stress, Psychological

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CONTROL GROUP
Arm Type
Placebo Comparator
Arm Description
Nutraceutical placebo intake group
Arm Title
PLX400mg GROUP
Arm Type
Experimental
Arm Description
Intake of natural herbal dietary supplement composed of lemon verbena extract (Lippia citriodora).
Intervention Type
Dietary Supplement
Intervention Name(s)
PLX
Intervention Description
Intake of natural food supplement of vegetable origin based on lemon verbena extract (Lippia citriodora). To study the anxiolytic effects in subjects with high perceived stress levels and low sleep quality.
Primary Outcome Measure Information:
Title
WEIGHT
Description
The weight of the subjects will be obtained using the TANITA (Tokyo, Japan).
Time Frame
3 months
Title
HEIGHT
Description
The height of the subjects will be measured with the SECA 123 stadiometer (Hamburg, Germany).
Time Frame
3 months
Title
BLOOD PREASURE
Description
Measurement of blood pressure (systolic and diastolic) with a digital tensiometer.
Time Frame
3 months
Title
FAT MASS
Description
Assessment of body composition using the TANITA (Tokyo, Japan) validated bioimpedance scale to obtain the results of fat mass.
Time Frame
3 months
Title
VISCERAL FAT
Description
Assessment of body composition using the TANITA (Tokyo, Japan) validated bioimpedance scale to obtain the results of visceral fat.
Time Frame
3 months
Title
BLOOD CORTISOL
Description
Cortisol levels in blood by blood analysis.
Time Frame
3 months
Title
SLEEP QUALITY
Description
Measurement of sleep quality using the Pittsburgh sleep quality index.
Time Frame
3 months
Title
STRESS
Description
Measurement of perceived stress using the Perceived Stress Scale (PSS).
Time Frame
3 months
Title
ANXIETY
Description
Measurement of perceived anxiety using the Spielberger Trait-State Anxiety Inventory questionnaire; it is an instrument created with the objective of assessing anxiety in two dimensions, state and trait.
Time Frame
3 months
Title
PERCEIVED QUALITY OF LIFE
Description
Measurement of quality of life using the World Health Organization Quality of Life (WHOQOL-BREF). The WHOQOL-BREF instrument provides a profile of quality of life, with each dimension or domain being scored independently. each dimension or domain scored independently. The higher the higher the score in each domain, the better the quality of life profile of the person being the person being assessed.
Time Frame
3 months
Title
HEART RATE
Description
An electrocardiogram is used to obtain the heart rate.
Time Frame
3 months
Title
SLEEP HOURS
Description
Use of a FITBIT device to monitor the hours of sleep of each participant.
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Over 21 years of age; Without any chronic pathology; Score on the Spielberg Trait-State Anxiety Inventory (STAI-S) comprising 20 items, greater than 40 (probable clinical levels of anxiety); Pittsburgh Sleep Quality Index (PSQI) score greater than 5 (poor sleep quality). Exclusion Criteria: Failure to meet the inclusion criteria.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alejandro Martinez Rodriguez, Assistant
Organizational Affiliation
Alicante University
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alicante
City
Alicante
ZIP/Postal Code
03203
Country
Spain

12. IPD Sharing Statement

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Study of the Effects of Plx on Bioparametric Measurements.

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