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Not yet recruiting NCT07462104

Metabolic Syndrome Associated Diet

— Observational Metabolic Syndrome (MetS) Periodontitis Diet, Food and Nutrition

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Metabolic Syndrome (MetS), Periodontitis, Diet, Food and Nutrition. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Pro-İnflammatory Diet as a Modifying Factor in Periodontal Tissue Destruction Associated With Metabolic Syndrome

Overview

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.

Primary outcome measures

  • Dietary Inflammatory Index [Time frame: Day 1]
Secondary outcome measures (5)
  • 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-only

Study locations

Turkey (Türkiye) · 1 center
  • Department of Periodontology of the Faculty of Dentistry of Recep Tayyip Erdogan Universit — Rize

Identifiers

NCT: NCT07462104 · MetSDiet08/25

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗