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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06154616
Other study ID # UCAMCFE-00033
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 15, 2023
Est. completion date January 19, 2024

Study information

Verified date September 2023
Source Universidad Católica San Antonio de Murcia
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Randomized, controlled, double-blind intervention study, with four parallel branches depending on the product consumed, to analyze the efficacy of different types of milks on the improvement of sleep quality.


Description:

The duration of the study will be 90 days (12 weeks). Each day they will have to consume the product under investigation. The subjects who meet the selection criteria will be randomly distributed in each of the study groups (A, B, C or D, depending on the group in which they have been randomized). Each day the subjects will have to fill in a diary on sleep quality and concomitant medication. They will make a total of two 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.


Recruitment information / eligibility

Status Completed
Enrollment 52
Est. completion date January 19, 2024
Est. primary completion date December 20, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: - Healthy adults (> 18 years). - Low sleep quality by Pittsburgh Sleep Quality Questionnaire (PSQI). - Volunteers able to understand the clinical study and willing to comply with the study procedures and requirements. Exclusion Criteria: - Subjects with serious or terminal illnesses. - Subjects with known allergy or hypersensitivity to any of the components of the investigational product. - Participation in another study involving blood draws or dietary intervention. - Subjects with body mass index above 32 kg/m2. - Pregnant or lactating women. - Use of medications that alter cognitive functions or sleep, such as barbiturates, anticonvulsants, benzodiazepines, antidepressants, neuroleptics, alcohol and illicit drugs. - Organic dementias such as Alzheimer's, Huntington's disease, Parkinson's and senile dementia. - Inability to understand informed consent (IC).

Study Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Control Product
Lactose-free skimmed milk
Experimental Product: 250
Lactose-free skimmed milk enriched with 250 mg aswaghanda
Experimental Product: 250 + TRP
Lactose-free skimmed milk enriched with 250 mg aswaghanda and tryptophan
Experimental Product: 600
Lactose-free skimmed milk enriched with 600 mg aswaghanda

Locations

Country Name City State
Spain Catholic University of Murcia Murcia

Sponsors (1)

Lead Sponsor Collaborator
Universidad Católica San Antonio de Murcia

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary Variation in sleep quality from baseline at 12 weeks. Visual analog scale from 0 to 10. The higher the value, the more quality. The evolution of sleep quality after consumption during 12 weeks will be measured.
Secondary Change in Sleep Quality from baseline at 12 weeks Visual analog scale from 0 to 10. The higher the value, the more quality. Sleep quality will be measured with a daily scale, from baseline to 12 weeks.
Secondary Sleep quality Measured by Pittsburgh test It will be measured twice, once at baseline or at the end of the study after 12 weeks of use
Secondary Insomnia severity Measured by Insomnia severity index - ISI test It will be measured twice, once at baseline or at the end of the study after 12 weeks of use
Secondary Sleepiness Measured by Epworth test It will be measured twice, once at baseline or at the end of the study after 12 weeks of use
Secondary Matutinity - Verpertinity Measured by Matutinity - Verpertinity questionnaire It will be measured twice, once at baseline or at the end of the study after 12 weeks of use
Secondary Anxiety questionnaire Test STAI, to measure the level of anxiety of the subjects Day 1, at 12 weeks later
Secondary Body composition It is a control variable. Measured by bioimpedance The test will be measured at baseline and after 12 weeks of consumption.
Secondary Adverse events It will be evaluated at each of the visits. At 12 weeks after consumption
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