NCT05128812

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable quality-of-life

Timeline
Completed

Started May 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2021

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 10, 2021

Completed
12 days until next milestone

First Posted

Study publicly available on registry

November 22, 2021

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

June 9, 2023

Status Verified

June 1, 2023

Enrollment Period

3 months

First QC Date

November 10, 2021

Last Update Submit

June 7, 2023

Conditions

Quality of LifeAntidepressive AgentsDepression, AnxietySleep Initiation and Maintenance DisordersBody CompositionStress, Psychological

Outcome Measures

Primary Outcomes (12)

  • WEIGHT

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

    3 months

  • HEIGHT

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

    3 months

  • BLOOD PREASURE

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

    3 months

  • FAT MASS

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

    3 months

  • VISCERAL FAT

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

    3 months

  • BLOOD CORTISOL

    Cortisol levels in blood by blood analysis.

    3 months

  • SLEEP QUALITY

    Measurement of sleep quality using the Pittsburgh sleep quality index.

    3 months

  • STRESS

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

    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.

    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.

    3 months

  • HEART RATE

    An electrocardiogram is used to obtain the heart rate.

    3 months

  • SLEEP HOURS

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

    3 months

Study Arms (2)

CONTROL GROUP

PLACEBO COMPARATOR

Nutraceutical placebo intake group

Dietary Supplement: PLX

PLX400mg GROUP

EXPERIMENTAL

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

Dietary Supplement: PLX

Interventions

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.

CONTROL GROUPPLX400mg GROUP

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Alicante

Alicante, 03203, Spain

Location

MeSH Terms

Conditions

DepressionAnxiety DisordersSleep Initiation and Maintenance DisordersStress, Psychological

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorMental DisordersSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Study Officials

  • Alejandro Martinez Rodriguez, Assistant

    Alicante University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

November 10, 2021

First Posted

November 22, 2021

Study Start

May 1, 2021

Primary Completion

July 31, 2021

Study Completion

December 1, 2022

Last Updated

June 9, 2023

Record last verified: 2023-06

Locations

ES(1)