Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-30 @ 8:43 PM
Study NCT ID:
NCT07462104
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-10
First Post:
2026-03-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Metabolic Syndrome Associated Diet
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D024821', 'term': 'Metabolic Syndrome'}, {'id': 'D010518', 'term': 'Periodontitis'}, {'id': 'D007249', 'term': 'Inflammation'}], 'ancestors': [{'id': 'D007333', 'term': 'Insulin Resistance'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D010510', 'term': 'Periodontal Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Serum blood samples Routine blood tests will include fasting blood glucose, HbA1c, triglyceride, HDL, and hsCRP levels.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'targetDuration': '1 Day', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-03-23', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2026-11-23', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-04', 'studyFirstSubmitDate': '2026-03-04', 'studyFirstSubmitQcDate': '2026-03-04', 'lastUpdatePostDateStruct': {'date': '2026-03-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-09-21', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Fasting Blood Glucose', 'timeFrame': 'Day 1', 'description': '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.'}, {'measure': 'Glycated Hemoglobin A1c', 'timeFrame': 'Day 1', 'description': '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.'}, {'measure': 'Triglyceride', 'timeFrame': 'Day 1', 'description': '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.'}, {'measure': 'Waist Circumference', 'timeFrame': 'Day 1', 'description': '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.'}, {'measure': 'High-Density Lipoprotein', 'timeFrame': 'Day 1', 'description': '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.'}, {'measure': 'High-Sensitivity C-Reactive Protein', 'timeFrame': 'Day 1', 'description': '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.'}, {'measure': 'Weight', 'timeFrame': 'Day 1', 'description': 'Weight is the gravitational force exerted on an object.'}, {'measure': 'Height', 'timeFrame': 'Day 1', 'description': 'Height: a measure of vertical distance, vertical dimension, or vertical position.'}], 'primaryOutcomes': [{'measure': 'Dietary Inflammatory Index', 'timeFrame': 'Day 1', 'description': "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."}], 'secondaryOutcomes': [{'measure': 'Clinical Periodontal Parameters (Plaque Index)', 'timeFrame': 'Day 1', 'description': "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.\n\nScore Description 0 No plaque.\n\n1. No visible plaque, but a slight film of plaque is detected when a probe is run along the gingival margin.\n2. Visible plaque along the gingival margin, forming a continuous band.\n3. Abundant plaque covering the gingival area and extending toward the middle of the tooth surface, including the interproximal spaces."}, {'measure': 'Clinical Periodontal Parameters (Gingival Index)', 'timeFrame': 'Day 1', 'description': "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.\n\nScore Description 0 Healthy gingiva: normal color and texture, no bleeding\n\n1. Mild inflammation: slight color change and swelling, no bleeding on probing\n2. Moderate inflammation: redness, edema, soft tissue, bleeding on probing\n3. Severe inflammation: marked redness and swelling, ulceration, possible spontaneous bleeding"}, {'measure': 'Periodontal Clinical Parametres (Bleeding on Probing Index)', 'timeFrame': 'Day 1', 'description': '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.\n\nScore Description: 0 No bleeding 1 Bleeding present (mild or severe)'}, {'measure': 'Periodontal Clinical Parametres (Probing Pocket Depth)', 'timeFrame': 'Day 1', 'description': '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.\n\nMeasurement Interpretation 1-3 mm Healthy sulcus 4-5 mm Shallow to moderate pocket\n\n≥6 mm Deep periodontal pocket (advanced disease)'}, {'measure': 'Periodontal Clinical Parametres (Clinical Attachment Loss)', 'timeFrame': 'Day 1', 'description': '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.\n\nCAL Value Interpretation 0-1 mm Healthy / minimal loss 2-3 mm Mild attachment loss 4-5 mm Moderate attachment loss\n\n≥6 mm Severe attachment loss'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['metabolic syndrome', 'periodontitis', 'diet', 'inflammation'], 'conditions': ['Metabolic Syndrome (MetS)', 'Periodontitis', 'Diet, Food and Nutrition']}, 'descriptionModule': {'briefSummary': '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.\n\nThe main question it aims to answer is:\n\nDoes a pro-inflammatory diet, as measured by the DII, increase the risk or severity of periodontitis in individuals with metabolic syndrome?\n\nParticipants 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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients diagnosed with metabolic syndrome who come to the Periodontology Clinic of Recep Tayyip Erdoğan University Faculty of Dentistry for routine periodontal treatment', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Being between 18 and 65 years of age\n* 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\n* Having at least 20 teeth\n* Not having received periodontal therapy in the last 6 months\n* Not having taken antibiotics, steroids, and/or nonsteroidal anti-inflammatory drugs in the last 3 weeks\n* Not having any autoimmune disease, osteoporosis, or cancer\n* Not taking immunosuppressive medications, oral contraceptives, Not taking bisphosphonates\n* Not being pregnant\n* Not having an active infectious disease (acute hepatitis, tuberculosis, AIDS)\n* Not taking chronic medications that affect periodontal tissues (cyclosporine A, phenytoin)\n* Not taking antioxidant supplements in the last 6 months\n\nExclusion Criteria:\n\n* Patients with an active infectious disease,\n* Those taking medications that could affect periodontal tissues,\n* History of endocarditis,\n* Recent antibiotic use (within 4 months),\n* Alcohol/drug use,\n* Psychological disorders,\n* Eating disorders,\n* Dementia,\n* Pregnancy and breastfeeding,\n* Patients who did not sign the informed consent form'}, 'identificationModule': {'nctId': 'NCT07462104', 'briefTitle': 'Metabolic Syndrome Associated Diet', 'organization': {'class': 'OTHER', 'fullName': 'Recep Tayyip Erdogan University Training and Research Hospital'}, 'officialTitle': 'Pro-İnflammatory Diet as a Modifying Factor in Periodontal Tissue Destruction Associated With Metabolic Syndrome', 'orgStudyIdInfo': {'id': 'MetSDiet08/25'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients diagnosed with metabolic syndrome', 'description': '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.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '53200', 'city': 'Rize', 'state': 'Rize Province', 'country': 'Turkey (Türkiye)', 'facility': 'Department of Periodontology of the Faculty of Dentistry of Recep Tayyip Erdogan University', 'geoPoint': {'lat': 41.02083, 'lon': 40.52194}}], 'centralContacts': [{'name': 'Oguz KOSE, Professor Dr.', 'role': 'CONTACT', 'email': 'oguz.kose@erdogan.edu.tr', 'phone': '+90 541 348 64 65'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Recep Tayyip Erdogan University Training and Research Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assoc. Prof. Dr.', 'investigatorFullName': 'Dilek KARADOĞAN', 'investigatorAffiliation': 'Recep Tayyip Erdogan University Training and Research Hospital'}}}}