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OpenTrials
Completed

NCT Number: NCT06154629

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

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.

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Key information

Conditions

Poor Quality Sleep

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Catholic University of Murcia

Murcia, 30107, Spain

About this study

Subjects who meet the selection criteria will be randomly assigned to each of the study groups (investigational product dose or placebo, depending on the group to which they have been assigned).

The product to be consumed is a botanical extract. Participants will consume the product for 90 days. They should consume one capsule one hour before going to sleep.

They will make a total of five visits to the research laboratory and the tests preestablished in the protocol will be performed. Subsequently, a statistical analysis will be performed with the variables measured in the study to obtain the results.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Botanical ingredient

Dietary Supplement

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

Control group

Dietary Supplement

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

Primary outcomes

  1. Variation in sleep quality from baseline at 12 weeks.

    Time frame: The evolution of sleep quality after consumption during 12 weeks will be measured.

    Visual analog scale from 0 to 10. The higher the value, the more quality.

Secondary outcomes

  1. Change in Sleep Quality from baseline at 12 weeks

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

    Visual analog scale from 0 to 10. The higher the value, the more quality.

  2. Sleep quality

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

    Measured by Pittsburgh test

  3. Sleep efficiency

    Time frame: 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).

    Measured by accelerometry, with Actigraph wGT3X-BT

  4. Anxiety questionnaire

    Time frame: Day 1, at 12 weeks later

    Test STAI, to measure the level of anxiety of the subjects

  5. Perceived stress scale

    Time frame: Day 1, at 12 weeks later

    Scale Remor, 2001. Test to measure the level of stress of the subjects

  6. Melatonine

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

    It is measured with a blood sample in the early evening.

  7. Cortisol

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

    Measured with blood sample first thing in the morning.

  8. Body composition

    Time frame: The test will be measured at baseline and after 12 weeks of consumption.

    It is a control variable. Measured by bioimpedance

  9. Physical activity control

    Time frame: 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).

    It is a control variable. Measured by Actigraph wGT3X-BT

  10. Liver safety variables

    Time frame: It will be measured twice, once at baseline or at the end of the study after 12 weeks.

    It is a blood test that measures the presence of some enzymes, proteins and bilirubin in the blood, with the aim of determining if there is any alteration in the liver. Enzyme GPT, GOT, Gamma GT, LDH, alkaline phosphatase and bilirubin (UI/L)

  11. Adverse events

    Time frame: At 12 weeks after consumption

    It will be evaluated at each of the visits.

Sponsors and collaborators

Lead sponsor

Universidad Católica San Antonio de Murcia

Other

Registry information

Acronym: Q-Sleep

Important dates

Study start
2023
Primary completion
2023
Study completion
2024
First posted
Dec 4, 2023
Registry last updated
Feb 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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