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Study of the Effects of Plx on Bioparametric Measurements.

Sponsor
University of Alicante (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT05128812
Collaborator
(none)
40
Enrollment
1
Location
2
Arms
7
Anticipated Duration (Months)
5.7
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: PLX
 N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Study of the Anxiolytic Effects, Improvement of Sleep Quality and Bioparametric Measures in Individuals Taking an Extract of Lippia Citriodora.
Actual Study Start Date :
May 1, 2021
Actual Primary Completion Date :
Jul 31, 2021
Anticipated Study Completion Date :
Dec 1, 2021

Arms and Interventions

Arm Intervention/Treatment
Placebo Comparator: CONTROL GROUP

Nutraceutical placebo intake group

Dietary Supplement: PLX
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.
Experimental: PLX400mg GROUP

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

Dietary Supplement: PLX
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.

Outcome Measures

Primary Outcome Measures

  1. WEIGHT [3 months]

    The weight of the subjects will be obtained using the TANITA (Tokyo, Japan).

  2. HEIGHT [3 months]

    The height of the subjects will be measured with the SECA 123 stadiometer (Hamburg, Germany).

  3. BLOOD PREASURE [3 months]

    Measurement of blood pressure (systolic and diastolic) with a digital tensiometer.

  4. FAT MASS [3 months]

    Assessment of body composition using the TANITA (Tokyo, Japan) validated bioimpedance scale to obtain the results of fat mass.

  5. VISCERAL FAT [3 months]

    Assessment of body composition using the TANITA (Tokyo, Japan) validated bioimpedance scale to obtain the results of visceral fat.

  6. BLOOD CORTISOL [3 months]

    Cortisol levels in blood by blood analysis.

  7. SLEEP QUALITY [3 months]

    Measurement of sleep quality using the Pittsburgh sleep quality index.

  8. STRESS [3 months]

    Measurement of perceived stress using the Perceived Stress Scale (PSS).

  9. ANXIETY [3 months]

    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.

  10. PERCEIVED QUALITY OF LIFE [3 months]

    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.

  11. HEART RATE [3 months]

    An electrocardiogram is used to obtain the heart rate.

  12. SLEEP HOURS [3 months]

    Use of a FITBIT device to monitor the hours of sleep of each participant.

Eligibility Criteria

Criteria

Ages Eligible for Study:
21 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Alicante Alicante Spain 03203

Sponsors and Collaborators

  • University of Alicante

Investigators

  • Principal Investigator: Alejandro Martinez Rodriguez, Assistant, Alicante University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Prof. Dr. Alejandro Martínez-Rodríguez, Assistant Professor, University of Alicante
ClinicalTrials.gov Identifier:
NCT05128812
Other Study ID Numbers:
  • UA-2021-03-26
First Posted:
Nov 22, 2021
Last Update Posted:
Dec 2, 2021
Last Verified:
Nov 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Sleep Initiation and Maintenance Disorders
Stress, Psychological

Study Results

No Results Posted as of Dec 2, 2021