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

Universidad Católica San Antonio de Murcia52 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

OTHER

Masking

QUADRUPLE

Enrollment

Conditions

Poor Quality Sleep

Interventions

Control ProductDIETARY_SUPPLEMENT

Lactose-free skimmed milk

Experimental Product: 250DIETARY_SUPPLEMENT

Lactose-free skimmed milk enriched with 250 mg aswaghanda

Experimental Product: 250 + TRPDIETARY_SUPPLEMENT

Lactose-free skimmed milk enriched with 250 mg aswaghanda and tryptophan

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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).

Locations (1)

Catholic University of Murcia

Murcia, Spain

Outcomes

Primary Outcomes

Variation in sleep quality from baseline at 12 weeks.

Visual analog scale from 0 to 10. The higher the value, the more quality.

Time frame: The evolution of sleep quality after consumption during 12 weeks will be measured.

Secondary Outcomes

Change in Sleep Quality from baseline at 12 weeks

Visual analog scale from 0 to 10. The higher the value, the more quality.

Time frame: Sleep quality will be measured with a daily scale, from baseline to 12 weeks.

Sleep quality

Measured by Pittsburgh test

Time frame: It will be measured twice, once at baseline or at the end of the study after 12 weeks of use

Insomnia severity

Measured by Insomnia severity index - ISI test

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: Day 1, at 12 weeks later

Body composition

Data from ClinicalTrials.gov

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