Quality of LifeNCT05128812
Study of the Effects of Plx on Bioparametric Measurements.
A study testing PLX in people with Quality of Life and Antidepressive Agents, run by University of Alicante at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Quality of Life, Antidepressive Agents, Depression, Anxiety
- What is being tested?
- PLX
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteSpain
- Study dates
- 1 May 2021to 1 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- Failure to meet the inclusion criteria.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study of the Anxiolytic Effects, Improvement of Sleep Quality and Bioparametric Measures in Individuals Taking an Extract of Lippia Citriodora.
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.
Read the 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.
- Conditions
- Quality of Life, Antidepressive Agents, Depression, Anxiety, Sleep Initiation and Maintenance Disorders, Body Composition, Stress, Psychological
- Being tested
- PLX
- Medical subject headings
- Depression, Anxiety Disorders, Sleep Initiation and Maintenance Disorders, Stress, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PLXDietary supplement
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.
| Study group | Role | What they receive |
|---|---|---|
| CONTROL GROUP | Placebo comparator | Nutraceutical placebo intake group Receives: Dietary Supplement: PLX |
| PLX400mg GROUP | Experimental | Intake of natural herbal dietary supplement composed of lemon verbena extract (Lippia citriodora). Receives: Dietary Supplement: PLX |
What is being measured
The primary outcome is the main question the study is designed to answer.
WEIGHT
The weight of the subjects will be obtained using the TANITA (Tokyo, Japan).
Measured: 3 months
HEIGHT
The height of the subjects will be measured with the SECA 123 stadiometer (Hamburg, Germany).
Measured: 3 months
BLOOD PREASURE
Measurement of blood pressure (systolic and diastolic) with a digital tensiometer.
Measured: 3 months
FAT MASS
Assessment of body composition using the TANITA (Tokyo, Japan) validated bioimpedance scale to obtain the results of fat mass.
Measured: 3 months
VISCERAL FAT
Assessment of body composition using the TANITA (Tokyo, Japan) validated bioimpedance scale to obtain the results of visceral fat.
Measured: 3 months
BLOOD CORTISOL
Cortisol levels in blood by blood analysis.
Measured: 3 months
SLEEP QUALITY
Measurement of sleep quality using the Pittsburgh sleep quality index.
Measured: 3 months
STRESS
Measurement of perceived stress using the Perceived Stress Scale (PSS).
Measured: 3 months
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.
Measured: 3 months
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.
Measured: 3 months
HEART RATE
An electrocardiogram is used to obtain the heart rate.
Measured: 3 months
SLEEP HOURS
Use of a FITBIT device to monitor the hours of sleep of each participant.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2021
- Study start1 May 2021
- Primary completion31 Jul 2021
- Study completion1 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Quality of LifeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alicante
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Dr. Alejandro Martínez-Rodríguez, University of Alicante
- Investigators
- Alejandro Martinez Rodriguez, Assistant, Principal investigator, Alicante University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05128812
- Sponsor's protocol ID
- UA-2021-03-26
- Status last verified
- Jun 2023
- First submitted
- 10 Nov 2021
- Last updated
- 9 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Anxiolytic Effects, Improvement of Sleep Quality and Bioparametric Measures in Individuals Taking an Extract of Lippia Citriodora.
- ClinicalTrials.gov ID
- NCT05128812
- Acronym / sponsor ID
- UA-2021-03-26
- Conditions
- Quality of Life, Antidepressive Agents, Depression, Anxiety, Sleep Initiation and Maintenance Disorders, Body Composition, Stress, Psychological
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of AlicanteUniversity, hospital or other
- Study start
- 1 May 2021 (actual)
- Primary completion
- 31 Jul 2021 (actual)
- Study completion
- 1 Dec 2022 (actual)
- First posted
- 22 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CONTROL GROUP | Placebo comparator | Dietary Supplement: PLXNutraceutical placebo intake group |
| PLX400mg GROUP | Experimental | Dietary Supplement: PLXIntake of natural herbal dietary supplement composed of lemon verbena extract (Lippia citriodora). |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (1 listed)
- Failure to meet the inclusion criteria.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PLXIntake 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. | Dietary supplement | CONTROL GROUP, PLX400mg GROUP |
Primary outcome
WEIGHT
Time frame: 3 months
The weight of the subjects will be obtained using the TANITA (Tokyo, Japan).
HEIGHT
Time frame: 3 months
The height of the subjects will be measured with the SECA 123 stadiometer (Hamburg, Germany).
BLOOD PREASURE
Time frame: 3 months
Measurement of blood pressure (systolic and diastolic) with a digital tensiometer.
FAT MASS
Time frame: 3 months
Assessment of body composition using the TANITA (Tokyo, Japan) validated bioimpedance scale to obtain the results of fat mass.
VISCERAL FAT
Time frame: 3 months
Assessment of body composition using the TANITA (Tokyo, Japan) validated bioimpedance scale to obtain the results of visceral fat.
BLOOD CORTISOL
Time frame: 3 months
Cortisol levels in blood by blood analysis.
SLEEP QUALITY
Time frame: 3 months
Measurement of sleep quality using the Pittsburgh sleep quality index.
STRESS
Time frame: 3 months
Measurement of perceived stress using the Perceived Stress Scale (PSS).
ANXIETY
Time frame: 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.
PERCEIVED QUALITY OF LIFE
Time frame: 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.
HEART RATE
Time frame: 3 months
An electrocardiogram is used to obtain the heart rate.
SLEEP HOURS
Time frame: 3 months
Use of a FITBIT device to monitor the hours of sleep of each participant.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alejandro Martinez Rodriguez, Assistant principal investigator
Alicante University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PLX in people with Quality of Life and Antidepressive Agents, run by University of Alicante at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
WEIGHT (time frame: 3 months). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2023.