Metabolic Syndrome (MetS)NCT07462104
Metabolic Syndrome Associated Diet
An observational study of Metabolic Syndrome (MetS) and Periodontitis, run by Recep Tayyip Erdogan University Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
The goal of this observational study is to examine the relationship between metabolic syndrome (MetS) and periodontitis, and to evaluate the role of the Dietary Inflammatory Index (DII) in this association. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Metabolic Syndrome (MetS), Periodontitis, Diet, Food and Nutrition
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 23 Mar 2026to 23 Nov 2026
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients diagnosed with metabolic syndrome who come to the Periodontology Clinic of Recep Tayyip Erdoğan University Faculty of Dentistry for routine periodontal treatment
Who may be able to join
- Being between 18 and 65 years of age
- Presence of at least three of the following parameters: (For MetS diagnosis) Waist circumference: ≥ 94 cm for men, ≥ 88 cm for women Blood pressure ≥ 130/85 mmHg or taking antihypertensive medication Fasting blood glucose ≥ 100 mg/dl or diagnosed with Type 2 Diabetes Triglycerides ≥ 1.7 mmol/L HDL < 1.29 mmol/L
- Having at least 20 teeth
- Not having received periodontal therapy in the last 6 months
- Not having taken antibiotics, steroids, and/or nonsteroidal anti-inflammatory drugs in the last 3 weeks
- Not having any autoimmune disease, osteoporosis, or cancer
Show all 11Show fewer
- Not taking immunosuppressive medications, oral contraceptives, Not taking bisphosphonates
- Not being pregnant
- Not having an active infectious disease (acute hepatitis, tuberculosis, AIDS)
- Not taking chronic medications that affect periodontal tissues (cyclosporine A, phenytoin)
- Not taking antioxidant supplements in the last 6 months
Who cannot join
- Patients with an active infectious disease,
- Those taking medications that could affect periodontal tissues,
- History of endocarditis,
- Recent antibiotic use (within 4 months),
- Alcohol/drug use,
- Psychological disorders,
Show all 10Show fewer
- Eating disorders,
- Dementia,
- Pregnancy and breastfeeding,
- Patients who did not sign the informed consent form
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Department of Periodontology of the Faculty of Dentistry of Recep Tayyip Erdogan University
Rize, Rize Province, 53200
About this study
Official title: Pro-İnflammatory Diet as a Modifying Factor in Periodontal Tissue Destruction Associated With Metabolic Syndrome
The goal of this observational study is to examine the relationship between metabolic syndrome (MetS) and periodontitis, and to evaluate the role of the Dietary Inflammatory Index (DII) in this association.
The main question it aims to answer is:
Read more
Does a pro-inflammatory diet, as measured by the DII, increase the risk or severity of periodontitis in individuals with metabolic syndrome?
Participants will include adults who meet the diagnostic criteria for metabolic syndrome. Their periodontal health will be assessed through standard clinical parameters, and dietary data will be collected using a validated food frequency questionnaire to calculate individual DII scores. The study will observe and analyze these factors to explore potential links between diet-induced inflammation, systemic metabolic health, and periodontal outcomes.
Read the detailed description
This study aims to investigate the potential relationship between metabolic syndrome (MetS) and periodontitis, and to evaluate this association through the Dietary Inflammatory Index (DII), which reflects the inflammatory potential of diet. Periodontal status will be assessed using clinical parameters (plaque index, probing pocket depth, clinical attachment loss, and gingival bleeding). MetS diagnosis will be based on criteria such as waist circumference, fasting glucose level, serum triglycerides, HDL cholesterol, and blood pressure. Dietary habits of participants will be analyzed using a validated food frequency questionnaire, and individual DII scores will be calculated. The data obtained will be used to evaluate the effects of dietary inflammatory load on systemic metabolic parameters and periodontal health. This study will aim to provide scientific evidence on the role of anti-inflammatory dietary strategies in periodontal and metabolic health.
- Keywords
- metabolic syndrome, periodontitis, diet, inflammation
- Medical subject headings
- Metabolic Syndrome, Periodontitis, Inflammation
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 |
|---|---|---|
| Patients diagnosed with metabolic syndrome | Metabolic syndrome is diagnosed according to the National Cholesterol Education Program Adult Treatment Panel III (NCEP/ATP III) criteria. Diagnosis is made by meeting three of the following five criteria: waist circumference: ≥ 94 cm in men and ≥ 88 cm in women, blood pressure ≥ 130/85 mmHg or use of antihypertensive medication, fasting blood glucose ≥ 100 mg/dL or diagnosed type 2 diabetes, triglycerides ≥ 1.7 mmol/L, and HDL < 1.29 mmol/L. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dietary Inflammatory Index
The Dietary Inflammatory Index (DII) provides a score that measures the potential for a person's diet to cause inflammation in the body. This index is based on the pro- or anti-inflammatory effects of consumed foods and nutrients. Participants' 3-day food intake records will be entered into the system, and average daily energy intake, macronutrients, and micronutrients will be calculated. Based on the food records, average daily intake of 36 nutrients will be determined, and DII scores will be derived from these nutrient parameters. A lower score indicates a more anti-inflammatory diet, while a higher score indicates a more pro-inflammatory diet.
Measured: Day 1
Secondary outcomes (5)
Clinical Periodontal Parameters (Plaque Index)
Plaque Index (PI) (Silness and Löe, 1964) This index is used to evaluate the amount of dental plaque accumulation on tooth surfaces. Each tooth's four surfaces (buccal, lingual, mesial, distal) are examined using a probe or visually. Each surface is scored from 0 to 3. The average score is calculated for each tooth. The overall plaque index is obtained by averaging the scores from all examined teeth.
Score Description 0 No plaque.
- No visible plaque, but a slight film of plaque is detected when a probe is run along the gingival margin.
- Visible plaque along the gingival margin, forming a continuous band.
- Abundant plaque covering the gingival area and extending toward the middle of the tooth surface, including the interproximal spaces.
Measured: Day 1
Clinical Periodontal Parameters (Gingival Index)
The Gingival Index is used to assess the presence and severity of gingival inflammation (gingivitis). Four surfaces of each tooth (buccal, lingual, mesial, distal) are examined visually and with a periodontal probe. The evaluation considers color changes, edema (swelling), tissue consistency, and bleeding on probing. Each surface is scored from 0 to 3. The average score per tooth is calculated, and then the overall average is used to determine the individual's GI score.
Score Description 0 Healthy gingiva: normal color and texture, no bleeding
- Mild inflammation: slight color change and swelling, no bleeding on probing
- Moderate inflammation: redness, edema, soft tissue, bleeding on probing
- Severe inflammation: marked redness and swelling, ulceration, possible spontaneous bleeding
Measured: Day 1
Periodontal Clinical Parametres (Bleeding on Probing Index)
This index is used to assess the presence and severity of gingival inflammation by observing bleeding after gentle pressure is applied to the gingival sulcus using a periodontal probe. A thin periodontal probe is gently inserted into the gingival sulcus with light pressure (approximately 20-25 grams). Bleeding occurring within 10-30 seconds is observed. Each measurement site is recorded as either "bleeding present" or "bleeding absent." Presence of bleeding is an early and sensitive indicator of gingival inflammation.
Score Description: 0 No bleeding 1 Bleeding present (mild or severe)
Measured: Day 1
Periodontal Clinical Parametres (Probing Pocket Depth)
Using a Williams periodontal probe, the distance between the gingival margin and the base of the periodontal pocket is measured in millimeters at six sites per tooth: mesiobuccal, midbuccal, distobuccal, mesiolingual, midlingual, and distolingual. All teeth are measured. The values obtained from each site are summed and then divided by the total number of sites measured. This gives the average probing depth for the individual.
Measurement Interpretation 1-3 mm Healthy sulcus 4-5 mm Shallow to moderate pocket
≥6 mm Deep periodontal pocket (advanced disease)
Measured: Day 1
Periodontal Clinical Parametres (Clinical Attachment Loss)
Using a Williams periodontal probe, the distance between the enamel-cementum junction and the base of the periodontal pocket is measured in millimeters at six sites per tooth: mesiobuccal, midbuccal, distobuccal, mesiolingual, midlingual, and distolingual. All teeth are measured. The values obtained from each site are summed and then divided by the total number of sites measured. This gives the average probing depth for the individual.
CAL Value Interpretation 0-1 mm Healthy / minimal loss 2-3 mm Mild attachment loss 4-5 mm Moderate attachment loss
≥6 mm Severe attachment loss
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2026
- Study start23 Mar 2026 (estimated)
- Primary completion21 Sep 2026 (estimated)
- Study completion23 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic Syndrome (MetS)Studies 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
- Cross-sectional
- Enrolment
- 100 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Recep Tayyip Erdogan University Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dilek KARADOĞAN, Recep Tayyip Erdogan University Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07462104
- Sponsor's protocol ID
- MetSDiet08/25
- Status last verified
- Feb 2026
- First submitted
- 4 Mar 2026
- Last updated
- 10 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 10 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pro-İnflammatory Diet as a Modifying Factor in Periodontal Tissue Destruction Associated With Metabolic Syndrome
- ClinicalTrials.gov ID
- NCT07462104
- Acronym / sponsor ID
- MetSDiet08/25
- Keywords
- metabolic syndrome, periodontitis, diet, inflammation
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Recep Tayyip Erdogan University Training and Research HospitalUniversity, hospital or other
- Study start
- 23 Mar 2026 (estimated)
- Primary completion
- 21 Sep 2026 (estimated)
- Study completion
- 23 Nov 2026 (estimated)
- First posted
- 10 Mar 2026 (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 goal of this observational study is to examine the relationship between metabolic syndrome (MetS) and periodontitis, and to evaluate the role of the Dietary Inflammatory Index (DII) in this association.
The main question it aims to answer is:
Does a pro-inflammatory diet, as measured by the DII, increase the risk or severity of periodontitis in individuals with metabolic syndrome?
Participants will include adults who meet the diagnostic criteria for metabolic syndrome. Their periodontal health will be assessed through standard clinical parameters, and dietary data will be collected using a validated food frequency questionnaire to calculate individual DII scores. The study will observe and analyze these factors to explore potential links between diet-induced inflammation, systemic metabolic health, and periodontal outcomes.
Detailed description
This study aims to investigate the potential relationship between metabolic syndrome (MetS) and periodontitis, and to evaluate this association through the Dietary Inflammatory Index (DII), which reflects the inflammatory potential of diet. Periodontal status will be assessed using clinical parameters (plaque index, probing pocket depth, clinical attachment loss, and gingival bleeding). MetS diagnosis will be based on criteria such as waist circumference, fasting glucose level, serum triglycerides, HDL cholesterol, and blood pressure. Dietary habits of participants will be analyzed using a validated food frequency questionnaire, and individual DII scores will be calculated. The data obtained will be used to evaluate the effects of dietary inflammatory load on systemic metabolic parameters and periodontal health. This study will aim to provide scientific evidence on the role of anti-inflammatory dietary strategies in periodontal and metabolic health.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients diagnosed with metabolic syndrome | – | –Metabolic syndrome is diagnosed according to the National Cholesterol Education Program Adult Treatment Panel III (NCEP/ATP III) criteria. Diagnosis is made by meeting three of the following five criteria: waist circumference: ≥ 94 cm in men and ≥ 88 cm in women, blood pressure ≥ 130/85 mmHg or use of antihypertensive medication, fasting blood glucose ≥ 100 mg/dL or diagnosed type 2 diabetes, triglycerides ≥ 1.7 mmol/L, and HDL < 1.29 mmol/L. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with metabolic syndrome who come to the Periodontology Clinic of Recep Tayyip Erdoğan University Faculty of Dentistry for routine periodontal treatment
Key inclusion criteria (11 listed)
- Being between 18 and 65 years of age
- Presence of at least three of the following parameters: (For MetS diagnosis) Waist circumference: ≥ 94 cm for men, ≥ 88 cm for women Blood pressure ≥ 130/85 mmHg or taking antihypertensive medication Fasting blood glucose ≥ 100 mg/dl or diagnosed with Type 2 Diabetes Triglycerides ≥ 1.7 mmol/L HDL < 1.29 mmol/L
- Having at least 20 teeth
- Not having received periodontal therapy in the last 6 months
- Not having taken antibiotics, steroids, and/or nonsteroidal anti-inflammatory drugs in the last 3 weeks
Key exclusion criteria (10 listed)
- Patients with an active infectious disease,
- Those taking medications that could affect periodontal tissues,
- History of endocarditis,
- Recent antibiotic use (within 4 months),
- Alcohol/drug use,
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
Dietary Inflammatory Index
Time frame: Day 1
The Dietary Inflammatory Index (DII) provides a score that measures the potential for a person's diet to cause inflammation in the body. This index is based on the pro- or anti-inflammatory effects of consumed foods and nutrients. Participants' 3-day food intake records will be entered into the system, and average daily energy intake, macronutrients, and micronutrients will be calculated. Based on the food records, average daily intake of 36 nutrients will be determined, and DII scores will be derived from these nutrient parameters. A lower score indicates a more anti-inflammatory diet, while a higher score indicates a more pro-inflammatory diet.
5 secondary outcomes
Clinical Periodontal Parameters (Plaque Index)
Time frame: Day 1
Clinical Periodontal Parameters (Gingival Index)
Time frame: Day 1
Periodontal Clinical Parametres (Bleeding on Probing Index)
Time frame: Day 1
Periodontal Clinical Parametres (Probing Pocket Depth)
Time frame: Day 1
Periodontal Clinical Parametres (Clinical Attachment Loss)
Time frame: Day 1
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2026.
- Individual participant dataSharing planned: No
Related trials for Metabolic Syndrome (MetS)
Recruiting
Multi-omics Dissection of Gut Microbiome Engraftment During FMT
Recurrent C. Difficile (rCDI), Ulcerative Colitis (UC)
Recruiting
Effect of Resistance Exercises on Serum IGF-1 Levels in Knee Osteoarthritis
Osteoarthritis (Knee), Metabolic Syndrome (MetS)
Recruiting
Preoperative Oral Carbohydrate Loading and Gastrointestinal Recovery After Bariatric Surgery in Metabolic Syndrome
Metabolic Syndrome (MetS)
Recruiting
Effectiveness of the Personalized Responses & Integrated Systems for Metabolism (PRISM) on Improving Insulin Resistance Among Adults With Metabolic Syndrome: A Pilot Study (PRISM-I)
Metabolic Syndrome (MetS)
Active, not recruiting
Metformin Withdrawal In Metabolic Syndrome
Metabolic Syndrome (MetS), Glucose Intolerance
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.
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 Metabolic Syndrome (MetS) and Periodontitis, run by Recep Tayyip Erdogan University Training and Research Hospital 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 11 inclusion and 10 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: opening soon, as of the sponsor's last update on 10 Mar 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Oguz KOSE, Professor Dr. (+90 541 348 64 65, oguz.kose@erdogan.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dietary Inflammatory Index (time frame: Day 1). 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 10 Mar 2026.