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

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

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.

Study Overview

• Status: Completed
• Conditions: Poor Quality Sleep
• Intervention / Treatment: Dietary supplement: Control Product; Dietary supplement: Experimental Product: 250; Dietary supplement: Experimental Product: 250 + TRP; Dietary supplement: Experimental Product: 600

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 52
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Murcia, Spain, 30107
    • Catholic University of Murcia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Control; Subjects will consume 250 ml of milk half an hour before bedtime.	Dietary supplement: Control Product; Lactose-free skimmed milk
Experimental: Ashw 250; Subjects will consume 250 ml of milk half an hour before bedtime.	Dietary supplement: Experimental Product: 250; Lactose-free skimmed milk enriched with 250 mg aswaghanda
Experimental: Ashw 250 + TRP; Subjects will consume 250 ml of milk half an hour before bedtime.	Dietary supplement: Experimental Product: 250 + TRP; Lactose-free skimmed milk enriched with 250 mg aswaghanda and tryptophan
Experimental: Ashw 600; Subjects will consume 250 ml of milk half an hour before bedtime.	Dietary supplement: Experimental Product: 600; Lactose-free skimmed milk enriched with 600 mg aswaghanda

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Body composition	It is a control variable. Measured by bioimpedance	The test will be measured at baseline and after 12 weeks of consumption.
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.
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
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
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
Anxiety questionnaire	Test STAI, to measure the level of anxiety of the subjects	Day 1, at 12 weeks later
Adverse events	It will be evaluated at each of the visits.	At 12 weeks after consumption

Collaborators and Investigators

• Sponsor: Universidad Católica San Antonio de Murcia

Study record dates

Study Major Dates

• Study Start (Actual): September 15, 2023
• Primary Completion (Actual): December 20, 2023
• Study Completion (Actual): January 19, 2024

Study Registration Dates

• First Submitted: November 23, 2023
• First Submitted That Met QC Criteria: December 1, 2023
• First Posted (Actual): December 4, 2023

Study Record Updates

• Last Update Posted (Actual): February 16, 2024
• Last Update Submitted That Met QC Criteria: February 15, 2024
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: tryptophan; Ashwagandha extract
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Sleep Wake Disorders; Dyssomnias; Parasomnias
• Other Study ID Numbers: UCAMCFE-00033

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No