- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07462104
Metabolic Syndrome Associated Diet
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:
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.
Study Overview
Status
Detailed Description
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Oguz KOSE, Professor Dr.
- Phone Number: +90 541 348 64 65
- Email: oguz.kose@erdogan.edu.tr
Study Locations
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Rize Province
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Rize, Rize Province, Turkey (Türkiye), 53200
- Department of Periodontology of the Faculty of Dentistry of Recep Tayyip Erdogan University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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
- 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
Exclusion Criteria:
- 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,
- Eating disorders,
- Dementia,
- Pregnancy and breastfeeding,
- Patients who did not sign the informed consent form
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Dietary Inflammatory Index
Time Frame: Day 1
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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.
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Day 1
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Clinical Periodontal Parameters (Plaque Index)
Time Frame: Day 1
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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.
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Day 1
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Clinical Periodontal Parameters (Gingival Index)
Time Frame: Day 1
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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
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Day 1
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Periodontal Clinical Parametres (Bleeding on Probing Index)
Time Frame: Day 1
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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) |
Day 1
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Periodontal Clinical Parametres (Probing Pocket Depth)
Time Frame: Day 1
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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) |
Day 1
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Periodontal Clinical Parametres (Clinical Attachment Loss)
Time Frame: Day 1
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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 |
Day 1
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Glycated Hemoglobin A1c
Time Frame: Day 1
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HbA1c (Glycated Hemoglobin A1c): A stable complex formed by the non-enzymatic covalent binding of glucose to the β-chain of hemoglobin, reflecting the average blood glucose level over the lifespan of erythrocytes (approximately 120 days).
It is considered a gold standard indicator of long-term glycemic control.
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Day 1
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Triglyceride
Time Frame: Day 1
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Triglyceride: A neutral lipid composed of three fatty acids esterified to a glycerol backbone.
It is primarily transported in plasma by VLDL and chylomicrons and serves as a biomarker of dyslipidemia and cardiometabolic risk.
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Day 1
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Height
Time Frame: Day 1
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Height: a measure of vertical distance, vertical dimension, or vertical position.
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Day 1
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Weight
Time Frame: Day 1
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Weight is the gravitational force exerted on an object.
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Day 1
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Waist Circumference
Time Frame: Day 1
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Waist Circumference: The individual stands upright.
A tape measure is taken horizontally at the narrowest point of the waist (usually between the bottom of the ribs and the top of the hipbone).
It is expressed in cm.
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Day 1
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Fasting Blood Glucose
Time Frame: Day 1
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Fasting Blood Glucose: The plasma glucose concentration measured after at least 8 hours of caloric restriction.
It is a fundamental biochemical parameter for assessing glycemic status and diagnosing diabetes.
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Day 1
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High-Density Lipoprotein
Time Frame: Day 1
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HDL (High-Density Lipoprotein): Lipoprotein particles of high density that play a central role in reverse cholesterol transport, shuttling cholesterol from peripheral tissues to the liver for excretion.
They exhibit anti-atherogenic, anti-inflammatory, and antioxidant properties.
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Day 1
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High-Sensitivity C-Reactive Protein
Time Frame: Day 1
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hsCRP (High-Sensitivity C-Reactive Protein): The low-level concentrations of the liver-derived acute-phase reactant CRP, measured by high-sensitivity immunoturbidimetric or nephelometric assays.
It serves as a biomarker of subclinical inflammation and cardiovascular risk.
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Day 1
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- MetSDiet08/25
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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