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

Universidad Católica San Antonio de Murcia

Status: Completed

Conditions: Poor Quality Sleep

Treatments: Dietary Supplement: Experimental Product: 600; Dietary Supplement: Control Product; Dietary Supplement: Experimental Product: 250 + TRP; Dietary Supplement: Experimental Product: 250

Study type: Interventional

Funder types: Other

Identifiers

NCT06154616

UCAMCFE-00033

Details and patient eligibility

About

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.

Full 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.

Enrollment: 52 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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).

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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52 participants in 4 patient groups, including a placebo group

Control

Placebo Comparator group

Description:

Subjects will consume 250 ml of milk half an hour before bedtime.

Treatment:

Dietary Supplement: Control Product

Ashw 250

Experimental group

Description:

Subjects will consume 250 ml of milk half an hour before bedtime.

Treatment:

Dietary Supplement: Experimental Product: 250

Ashw 250 + TRP

Experimental group

Description:

Subjects will consume 250 ml of milk half an hour before bedtime.

Treatment:

Dietary Supplement: Experimental Product: 250 + TRP

Ashw 600

Experimental group

Description:

Subjects will consume 250 ml of milk half an hour before bedtime.

Treatment:

Dietary Supplement: Experimental Product: 600