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

NCT06154616 | Completed DMC

• 1 other identifier: UCAMCFE-00033
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Poor Quality Sleep

Keywords

Ashwagandha extract; tryptophan

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Change in Sleep Quality from baseline at 12 weeks

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

• Sleep quality

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

• Insomnia severity

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

• Sleepiness

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

• Matutinity - Verpertinity

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

Study Arms (4)

Control

PLACEBO COMPARATOR

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

Dietary Supplement: Control Product

Ashw 250

EXPERIMENTAL

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

Dietary Supplement: Experimental Product: 250

Ashw 250 + TRP

EXPERIMENTAL

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

Dietary Supplement: Experimental Product: 250 + TRP

Ashw 600

EXPERIMENTAL

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

Dietary Supplement: Experimental Product: 600

Interventions

Control Product DIETARY_SUPPLEMENT

Lactose-free skimmed milk

Control

Experimental Product: 250 DIETARY_SUPPLEMENT

Lactose-free skimmed milk enriched with 250 mg aswaghanda

Ashw 250

Experimental Product: 250 + TRP DIETARY_SUPPLEMENT

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

Ashw 250 + TRP

Experimental Product: 600 DIETARY_SUPPLEMENT

Lactose-free skimmed milk enriched with 600 mg aswaghanda

Ashw 600

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Universidad Católica San Antonio de Murcia: lead

Study Sites (1)

Catholic University of Murcia

Murcia, 30107, Spain

Location

MeSH Terms

Interventions

Control Groups; tryptophyltryptophan

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 23, 2023
• First Posted: December 4, 2023
• Study Start: September 15, 2023
• Primary Completion: December 20, 2023
• Study Completion: January 19, 2024
• Last Updated: February 16, 2024

Record last verified: 2023-09

Locations

ES (1)