NCT07062640

Brief Summary

The aim was to evaluate the relationship between dietary AGE intake and sleep quality and some nutrient intake of healthy children aged 3-5 years registered in various nurseries in Ankara. The main question that the study aimed to answer is: Does dietary AGE intake affect sleep quality in preschool children? 304 children (140 girls, 164 boys) were included in the study. According to the SDSC scale, 67.5% of the participants were at risk of sleep disorders. The dAGE intake of children at risk of sleep disorders was significantly higher compared to children with normal sleep status.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
304

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 28, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 13, 2025

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

July 3, 2025

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 14, 2025

Completed
Last Updated

July 14, 2025

Status Verified

July 1, 2025

Enrollment Period

4 months

First QC Date

July 3, 2025

Last Update Submit

July 3, 2025

Conditions

Outcome Measures

Primary Outcomes (2)

  • sleep quality

    To categorize sleep disturbances in children, the psychometric properties were evaluated using the 27-item Likert-type rating scale, the SDSC. The total score is 26 - 130. As the score increases, sleep quality deteriorates.

    Baseline

  • dAGE intake

    Dietary AGE measurements were calculated based on the database of Uribarri et al. A 24-hour retrospective food consumption record was obtained from the children.

    Baseline

Study Arms (2)

sleep disordered

sleep disordered with preschool children

normal

normal sleep with preschool children

Eligibility Criteria

Age3 Years - 5 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Healthy children aged 3-5 registered in various nurseries in Ankara

You may qualify if:

  • Individuals must be between 3-5 years old
  • Individuals must participate in the study voluntarily
  • Individuals must not have cognitive dysfunction
  • They must be able to answer the survey questions

You may not qualify if:

  • Individuals are not 3-5 years old
  • Individuals do not want to participate in the study voluntarily
  • Individuals have cognitive dysfunction
  • Inability to answer survey questions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara

Ankara, Ankara, 06320, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Child Nutrition Disorders

Condition Hierarchy (Ancestors)

Nutrition DisordersNutritional and Metabolic Diseases

Study Officials

  • Büşra Demirer, PhD

    Karabuk University

    PRINCIPAL INVESTIGATOR
  • Gökçen Doğan, PhD

    Lokman Hekim University

    STUDY DIRECTOR
  • Nurcan Yabancı Ayhan, Prof.Dr.

    Ankara University

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

July 3, 2025

First Posted

July 14, 2025

Study Start

January 1, 2025

Primary Completion

April 28, 2025

Study Completion

June 13, 2025

Last Updated

July 14, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations