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Completed

NCT Number: NCT06154616

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

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.

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Key information

Conditions

Poor Quality Sleep

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Catholic University of Murcia

Murcia, 30107, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Control product

Dietary Supplement

Lactose-free skimmed milk

Experimental Product: 250

Dietary Supplement

Lactose-free skimmed milk enriched with 250 mg aswaghanda

Experimental Product: 250 + TRP

Dietary Supplement

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

Experimental Product: 600

Dietary Supplement

Lactose-free skimmed milk enriched with 600 mg aswaghanda

Primary outcomes

  1. Variation in sleep quality from baseline at 12 weeks.

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

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

Secondary outcomes

  1. Change in Sleep Quality from baseline at 12 weeks

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

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

  2. Sleep quality

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

    Measured by Pittsburgh test

  3. Insomnia severity

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

    Measured by Insomnia severity index - ISI test

  4. Sleepiness

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

    Measured by Epworth test

  5. Matutinity - Verpertinity

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

    Measured by Matutinity - Verpertinity questionnaire

  6. Anxiety questionnaire

    Time frame: Day 1, at 12 weeks later

    Test STAI, to measure the level of anxiety of the subjects

  7. Body composition

    Time frame: The test will be measured at baseline and after 12 weeks of consumption.

    It is a control variable. Measured by bioimpedance

  8. Adverse events

    Time frame: At 12 weeks after consumption

    It will be evaluated at each of the visits.

Sponsors and collaborators

Lead sponsor

Universidad Católica San Antonio de Murcia

Other

Registry information

Official study 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

Acronym: Milca

Important dates

Study start
2023
Primary completion
2023
Study completion
2024
First posted
Dec 4, 2023
Registry last updated
Feb 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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