NCT06154616

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 52 (actual)
• Sponsor: Universidad Católica San Antonio de Murcia · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

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.

Conditions

• Poor Quality Sleep

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Control Product	Lactose-free skimmed milk
DIETARY_SUPPLEMENT	Experimental Product: 250	Lactose-free skimmed milk enriched with 250 mg aswaghanda
DIETARY_SUPPLEMENT	Experimental Product: 250 + TRP	Lactose-free skimmed milk enriched with 250 mg aswaghanda and tryptophan
DIETARY_SUPPLEMENT	Experimental Product: 600	Lactose-free skimmed milk enriched with 600 mg aswaghanda

Timeline

• Start date: 2023-09-15
• Primary completion: 2023-12-20
• Completion: 2024-01-19
• First posted: 2023-12-04
• Last updated: 2024-02-16

Locations

1 site across 1 country: Spain