Child Nutrition DisordersNCT07062640
Sleep Quality and dAGE Intake in Preschool Children
An observational study of Child Nutrition Disorders, run by Karabuk University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 5 yearsHealthy volunteers can take part
- Conditions the study is for
- Child Nutrition Disorders
- How many people
- 304 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2025to 13 Jun 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 5 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Healthy children aged 3-5 registered in various nurseries in Ankara
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Risk of Sleep Disordered and Dietary Advanced Glycation End Products in Preschool Children
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.
- Conditions
- Child Nutrition Disorders
- Medical subject headings
- Child Nutrition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| sleep disordered | sleep disordered with preschool children | |
| normal | normal sleep with preschool children |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2025
- Study start1 Jan 2025
- Primary completion28 Apr 2025
- Study completion13 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Child Nutrition DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 304 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karabuk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Büşra Demirer, Karabuk University
- Investigators
- Büşra Demirer, PhD, Principal investigator, Karabuk UniversityGökçen Doğan, PhD, Study director, Lokman Hekim UniversityNurcan Yabancı Ayhan, Prof.Dr., Study chair, Ankara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07062640
- Sponsor's protocol ID
- BD14
- Status last verified
- Jul 2025
- First submitted
- 3 Jul 2025
- Last updated
- 14 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Risk of Sleep Disordered and Dietary Advanced Glycation End Products in Preschool Children
- ClinicalTrials.gov ID
- NCT07062640
- Acronym / sponsor ID
- BD14
- Conditions
- Child Nutrition Disorders
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 304 participants (actual)
- Lead sponsor
- Karabuk UniversityUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 28 Apr 2025 (actual)
- Study completion
- 13 Jun 2025 (actual)
- First posted
- 14 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| sleep disordered | – | –sleep disordered with preschool children |
| normal | – | –normal sleep with preschool children |
Who may qualify
- Ages
- 3 to 5 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Healthy children aged 3-5 registered in various nurseries in Ankara
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
sleep quality
Time frame: Baseline
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.
dAGE intake
Time frame: Baseline
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Büşra Demirer, PhD principal investigator
Karabuk University
Gökçen Doğan, PhD study director
Lokman Hekim University
Nurcan Yabancı Ayhan, Prof.Dr. study chair
Ankara University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Child Nutrition Disorders, run by Karabuk University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
sleep quality (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2025.