Efficacy of Different Types of Milk in Improving Sleep Quality in Subjects With Sleep Problems (Milca)

Poor Quality Sleep Clinical Trial

— Milca  

Official title:

Analysis of the Efficacy of Different Types of Milk Enriched With Tryptophan and Supplemented With Ashwagandha Extract in Improving Sleep Quality in Subjects With Sleep Problems

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06154616
• Other study ID #: UCAMCFE-00033
• Status: Completed
• Phase: N/A
• 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
• 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).

Related Conditions & MeSH terms

• Dyssomnias
• Parasomnias
• Poor Quality Sleep

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