Nutrition, HealthyNCT06425328
Effect of Nutritional Habits on Oral Microbiota in Adolescents
An observational study of Nutrition, Healthy and Adolescent Behavior, run by TC Erciyes University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to examine the relationship between oral microbiota and eating habits, sleep quality and hedonic hunger in adolescents. Read more about this study
- Who is it for?
- Ages 14 to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Nutrition, Healthy, Adolescent Behavior, Microbial Colonization
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 14 Jun 2023to 17 Nov 2023
- 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 14 to 16 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: The study included 40 adolescents aged 14-16, who were thin, healthy, slightly overweight and obese, who applied to İsmet Yılmaz Akansu Family Health Center and met the inclusion criteria.
Who may be able to join
- 14-16 years old
- Not receiving special medical nutrition therapy
- No chronic systemic disease, nutritional disorder and/or endocrine disease that may affect growth and development
- Adolescents without congenital developmental disorders
Who cannot join
- Those who had any severe oral disease or periodontal treatment including supragingival curettage and root planning before the study
- Those who used any antibiotic, anti-inflammatory or sedative medication until 3 months before the study
- Those with bleeding gums on the working day or within the previous 4 weeks
- Those who smoke
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this study is to examine the relationship between oral microbiota and eating habits, sleep quality and hedonic hunger in adolescents.
Read the detailed description
Oral microbiota; While it is associated with systemic diseases such as obesity, diabetes and cancer, it is also associated with oral diseases such as oral cancers, tooth decay and gum diseases. Nutrition is seen as an important factor in maintaining oral health. In particular, the amount and frequency of sugar consumption, the type and consistency of food, the frequency of eating, the consumption of cariogenic foods with other foods and the duration of carbohydrates remaining on the teeth are among the factors that affect oral health. The aim of this study is to examine the relationship between oral microbiota and eating habits, sleep quality and hedonic hunger in adolescents. The study is planned to be carried out in 4 stages. First stage; A survey form will be filled out that questions general information about children, oral health practices, nutritional habits and frequency of food consumption. In the second stage; Children's anthropometric measurements (body weight (kg), height (cm), waist circumference (cm) will be taken and bioelectrical impedance analysis (BIA) results will be recorded. In the third stage, oral examinations of the children will be performed. In the final stage, saliva samples of the children will be collected. Bacteria Logarithmic values will be used when comparing the concentrations between groups. The suitability of the parameters to normal distribution will be evaluated with q-q graphs and Shapiro-Wilk test. Student t test will be used for variables that comply with normal distribution and Mann Whitney U test will be used for changes that do not comply with normal distribution. The relationship will be evaluated with the Spearman or Pearson correlation test according to the normality distribution. IBM SPSS (Statistical Package for Social Sciences) 22.0 package program will be used when evaluating the data obtained as a result of the study. While examining the hypothesis tests, α = 0.05 and accordingly the confidence interval will be determined as 95%. It will be evaluated at p<0.05 level. In order to enable healthy adolescents to reach a good standard of living, there is a need for a more accurate understanding of the relationship between oral microbiota, nutrition and sleep. As a result of this study, it is aimed to reveal the relationship between oral microbiota and eating habits, sleep quality and hedonic hunger in adolescents.
- Keywords
- adolescent, Nutritional Sciences, Oral Health
- Medical subject headings
- Adolescent Behavior, Communicable Diseases
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 |
|---|---|---|
| Underweight | BMI calculation was calculated with the equation "body weight (kg) / height (m)2" using body weight and height measurement results. BMI was evaluated according to the World Health Organization's BMI Z score classification for ages 5-19. Accordingly, those with a BMI z score below -1 SD are defined as underweight. | |
| Normal weight | BMI calculation was calculated with the equation "body weight (kg) / height (m)2" using body weight and height measurement results. BMI was evaluated according to the World Health Organization's BMI Z score classification for ages 5-19. Accordingly, BMI z scores between -1 SD +1 SD are defined as normal weight. | |
| Overweight | BMI calculation was calculated with the equation "body weight (kg) / height (m)2" using body weight and height measurement results. BMI was evaluated according to the World Health Organization's BMI Z score classification for ages 5-19. Accordingly, those with a BMI z score between +1 SD +2 SD are defined as overweight | |
| Obese | BMI calculation was calculated with the equation "body weight (kg) / height (m)2" using body weight and height measurement results. BMI was evaluated according to the World Health Organization's BMI Z score classification for ages 5-19. Accordingly, those with a BMI z score above +2 SD are defined as obese. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oral microbiome characteristics
For oral microbiota analysis, saliva samples were taken from children who had brushed their teeth in the morning and had not consumed any food until 2 hours before, and microbiological procedures were performed. Saliva samples taken from all patients participating in the study were stored at -80°C until analysis. Saliva samples collected during the research process were transported to the center where the analyzes were carried out by preserving the cold chain, and DNA isolation and sequence analysis were carried out together with molecular biologists. DNA purification from saliva samples was carried out using standard commercial methods. In the polymerase chain reaction-based amplification of bacterial 16S rRNA sequences, primers belonging to the V3-V4 region, which were previously defined and stated to be suitable for the detection of bacterial diversity, were used.
Measured: 1 month
Secondary outcomes (5)
Anthropometric Measurements
BMI calculation was calculated with the equation "body weight (kg) / height (m)2" using body weight and height measurement results. BMI was evaluated according to the World Health Organization's BMI Z score classification for ages 5-19.
Measured: 1 month
3 day food consumption record
On the first day of the food consumption record, a 24-hour retrospective was taken by the researcher, and on the other days, it was recorded in detail by telephone.
Measured: 1 month
Oral Examination
Intraoral examination of all children in the study group was performed by sitting on a chair by the window and using a mirror-probe in daylight. Intraoral examination of all children was performed by a single pediatric dentist (E.D.) and recorded in the patient information form. The total number of decayed, missing and filled teeth (Decayed, Missing, And Filled Teeth: DMFT) and tooth surfaces (Decayed, Missing, And Filled Surfaces: DMFS) were calculated.
Measured: 1 month
Pittsburg sleep quality index
It is a 19-question survey that evaluates sleep quality and disorders by scoring them over a one-month period. The seven component scores are then summed to yield one global score, with a range of 0-21 points (0 indicating no difficulty, and 21 indicating severe difficulties in all the seven areas of sleep quality).
Measured: 1 month
Children's Power of Food Scale
It is a 15-question survey developed to be used to determine hedonic hunger in school-age children. Items are rated on a 5-point Likert scale and summed to create a total score. Higher scores reflect greater responsiveness to the food environment.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2024
- Study start14 Jun 2023
- Primary completion17 Nov 2023
- Study completion17 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nutrition, HealthyStudies of the same condition, open and under way.
- More trials run by TC Erciyes UniversityThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- TC Erciyes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Betül Cicek, TC Erciyes University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06425328
- Sponsor's protocol ID
- ErciyesU-BVD-BAG-01
- Status last verified
- May 2024
- First submitted
- 17 May 2024
- Last updated
- 3 Jun 2024
- 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 3 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Nutritional Habits on Oral Microbiota in Adolescents
- ClinicalTrials.gov ID
- NCT06425328
- Acronym / sponsor ID
- ErciyesU-BVD-BAG-01
- Keywords
- adolescent, Nutritional Sciences, Oral Health
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- TC Erciyes UniversityUniversity, hospital or other
- Study start
- 14 Jun 2023 (actual)
- Primary completion
- 17 Nov 2023 (actual)
- Study completion
- 17 Nov 2023 (actual)
- First posted
- 22 May 2024 (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 of this study is to examine the relationship between oral microbiota and eating habits, sleep quality and hedonic hunger in adolescents.
Detailed description
Oral microbiota; While it is associated with systemic diseases such as obesity, diabetes and cancer, it is also associated with oral diseases such as oral cancers, tooth decay and gum diseases. Nutrition is seen as an important factor in maintaining oral health. In particular, the amount and frequency of sugar consumption, the type and consistency of food, the frequency of eating, the consumption of cariogenic foods with other foods and the duration of carbohydrates remaining on the teeth are among the factors that affect oral health. The aim of this study is to examine the relationship between oral microbiota and eating habits, sleep quality and hedonic hunger in adolescents. The study is planned to be carried out in 4 stages. First stage; A survey form will be filled out that questions general information about children, oral health practices, nutritional habits and frequency of food consumption. In the second stage; Children's anthropometric measurements (body weight (kg), height (cm), waist circumference (cm) will be taken and bioelectrical impedance analysis (BIA) results will be recorded. In the third stage, oral examinations of the children will be performed. In the final stage, saliva samples of the children will be collected. Bacteria Logarithmic values will be used when comparing the concentrations between groups. The suitability of the parameters to normal distribution will be evaluated with q-q graphs and Shapiro-Wilk test. Student t test will be used for variables that comply with normal distribution and Mann Whitney U test will be used for changes that do not comply with normal distribution. The relationship will be evaluated with the Spearman or Pearson correlation test according to the normality distribution. IBM SPSS (Statistical Package for Social Sciences) 22.0 package program will be used when evaluating the data obtained as a result of the study. While examining the hypothesis tests, α = 0.05 and accordingly the confidence interval will be determined as 95%. It will be evaluated at p<0.05 level. In order to enable healthy adolescents to reach a good standard of living, there is a need for a more accurate understanding of the relationship between oral microbiota, nutrition and sleep. As a result of this study, it is aimed to reveal the relationship between oral microbiota and eating habits, sleep quality and hedonic hunger in adolescents.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Underweight | – | –BMI calculation was calculated with the equation "body weight (kg) / height (m)2" using body weight and height measurement results. BMI was evaluated according to the World Health Organization's BMI Z score classification for ages 5-19. Accordingly, those with a BMI z score below -1 SD are defined as underweight. |
| Normal weight | – | –BMI calculation was calculated with the equation "body weight (kg) / height (m)2" using body weight and height measurement results. BMI was evaluated according to the World Health Organization's BMI Z score classification for ages 5-19. Accordingly, BMI z scores between -1 SD +1 SD are defined as normal weight. |
| Overweight | – | –BMI calculation was calculated with the equation "body weight (kg) / height (m)2" using body weight and height measurement results. BMI was evaluated according to the World Health Organization's BMI Z score classification for ages 5-19. Accordingly, those with a BMI z score between +1 SD +2 SD are defined as overweight |
| Obese | – | –BMI calculation was calculated with the equation "body weight (kg) / height (m)2" using body weight and height measurement results. BMI was evaluated according to the World Health Organization's BMI Z score classification for ages 5-19. Accordingly, those with a BMI z score above +2 SD are defined as obese. |
Who may qualify
- Ages
- 14 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- The study included 40 adolescents aged 14-16, who were thin, healthy, slightly overweight and obese, who applied to İsmet Yılmaz Akansu Family Health Center and met the inclusion criteria.
Key inclusion criteria (4 listed)
- 14-16 years old
- Not receiving special medical nutrition therapy
- No chronic systemic disease, nutritional disorder and/or endocrine disease that may affect growth and development
- Adolescents without congenital developmental disorders
Key exclusion criteria (4 listed)
- Those who had any severe oral disease or periodontal treatment including supragingival curettage and root planning before the study
- Those who used any antibiotic, anti-inflammatory or sedative medication until 3 months before the study
- Those with bleeding gums on the working day or within the previous 4 weeks
- Those who smoke
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
Oral microbiome characteristics
Time frame: 1 month
For oral microbiota analysis, saliva samples were taken from children who had brushed their teeth in the morning and had not consumed any food until 2 hours before, and microbiological procedures were performed. Saliva samples taken from all patients participating in the study were stored at -80°C until analysis. Saliva samples collected during the research process were transported to the center where the analyzes were carried out by preserving the cold chain, and DNA isolation and sequence analysis were carried out together with molecular biologists. DNA purification from saliva samples was carried out using standard commercial methods. In the polymerase chain reaction-based amplification of bacterial 16S rRNA sequences, primers belonging to the V3-V4 region, which were previously defined and stated to be suitable for the detection of bacterial diversity, were used.
5 secondary outcomes
Anthropometric Measurements
Time frame: 1 month
3 day food consumption record
Time frame: 1 month
Oral Examination
Time frame: 1 month
Pittsburg sleep quality index
Time frame: 1 month
Children's Power of Food Scale
Time frame: 1 month
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 3 Jun 2024.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Nutrition, Healthy and Adolescent Behavior, run by TC Erciyes 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 3 Jun 2024. 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?
Oral microbiome characteristics (time frame: 1 month). 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 3 Jun 2024.