Metabolic Syndrome Associated Diet

NCT07462104 | Not Yet Recruiting DMC

• 1 other identifier: MetSDiet08/25
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Metabolic Syndrome (MetS); Periodontitis; Diet, Food and Nutrition

Keywords

metabolic syndrome; periodontitis; diet; inflammation

Outcome Measures

Primary Outcomes (1)

• 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.

  Day 1

Secondary Outcomes (5)

• Clinical Periodontal Parameters (Plaque Index)

  Day 1

• Clinical Periodontal Parameters (Gingival Index)

  Day 1

• Periodontal Clinical Parametres (Bleeding on Probing Index)

  Day 1

• Periodontal Clinical Parametres (Probing Pocket Depth)

  Day 1

• Periodontal Clinical Parametres (Clinical Attachment Loss)

  Day 1

Other Outcomes (8)

• Fasting Blood Glucose

  Day 1

• Glycated Hemoglobin A1c

  Day 1

• Triglyceride

  Day 1

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Recep Tayyip Erdogan University Training and Research Hospital: lead

Study Sites (1)

Department of Periodontology of the Faculty of Dentistry of Recep Tayyip Erdogan University

Rize, Rize Province, 53200, Turkey (Türkiye)

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum blood samples Routine blood tests will include fasting blood glucose, HbA1c, triglyceride, HDL, and hsCRP levels.

MeSH Terms

Conditions

Metabolic Syndrome; Periodontitis; Inflammation

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Oguz KOSE, Professor Dr.

CONTACT

+90 541 348 64 65; oguz.kose@erdogan.edu.tr

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof. Dr.

Study Record Dates

• First Submitted: March 4, 2026
• First Posted: March 10, 2026
• Study Start: March 23, 2026
• Primary Completion (Estimated): September 21, 2026
• Study Completion (Estimated): November 23, 2026
• Last Updated: March 10, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)