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NCT Number: NCT07293624

Effects of the Dietary Inflammatory Index on Systemic Inflammation Markers and Gastrointestinal Symptoms in Individuals With Bariatric Surgery

The goal of this observational cross-sectional study is to evaluate the relationships between the Dietary Inflammatory Index (DII), systemic inflammatory markers, and gastrointestinal symptoms in adults aged 18-65 who have undergone bariatric surgery.

The main questions it aims to answer are:

Does the inflammatory potential of the diet affect systemic inflammation levels (such as SII, CRP, and WBC) in the post-operative period?

Is there an association between the DII score and gastrointestinal symptoms (e.g., bloating, gas, abdominal pain)?

Participants who are at least three months post-bariatric surgery will provide dietary intake data to calculate DII scores, undergo blood tests to measure inflammatory markers, and complete assessments regarding their gastrointestinal symptoms.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Istanbul Bilgi University

Istanbul, Uskudar, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult individuals between the ages of 18 and 65,
  • Having undergone bariatric surgery at least 3 months prior,
  • Individuals who agreed to participate voluntarily in the study and signed the informed consent form,
  • Having the cognitive ability/literacy to completely complete the food consumption record and questionnaire forms,
  • Individuals with no health conditions that would prevent blood tests,
  • Individuals who were regularly followed up after surgery and had no postoperative complications.

Exclusion criteria

  • Individuals diagnosed with gastrointestinal diseases such as inflammatory bowel disease, celiac disease, or short bowel syndrome before or after bariatric surgery,
  • Those with a history of diseases that could affect systemic inflammation, such as autoimmune disease, active infection, or cancer,
  • Individuals regularly taking medications that could affect inflammation levels, such as corticosteroids, immunosuppressants, or anti-inflammatory drugs,
  • Individuals actively or recently using probiotic supplements,
  • Pregnant or breastfeeding women,
  • Those with a history of chronic alcohol use or substance abuse,
  • Individuals who experienced serious postoperative complications after surgery (e.g., anastomotic leak, serious infection, or conditions requiring reoperation),
  • Individuals with cognitive or communication disabilities that prevented them from providing the necessary information and data to the study or who were lost to follow-up,
  • Individuals with chronic organ failure,
  • Individuals with a psychiatric diagnosis,
  • Individuals who did not consent to their data being used for scientific purposes.

Treatment and study plan

Observational Intervention

Other

This is cross sectional observational study.

Observetional

Other

This is cross-sectional study. Questionnaire, Dietary Inflammatory Index (DII), systemic inflammatory markers, and gastrointestinal symptoms will be investigated.

Primary outcomes

  1. Biochemical Measurements - Fasting blood glucose

    Time frame: at the beginning the study 1 times

    Fasting blood sugar (mg/dL) will be analyzed in the hospital biochemistry laboratory using routine methods from blood samples taken by a nurse at the beginning of the study.

  2. Biochemical Measurement - Lipid Profile

    Time frame: at the beginning the study 1 times

    Participants' biochemical tests (total cholesterol, HDL cholesterol, LDL cholesterol, triglyceride, (mg/dL) will be analyzed in the hospital biochemistry laboratory using routine methods at the beginning of the study from blood samples taken by a nurse after at least 12 hours of fasting and without consuming alcohol for 24 hours before.

  3. Biochemical Measurements - Liver Enzymes

    Time frame: at the beginning the study 1 times

    Participants' liver enzymes tests (ALT, AST, and ALP) (IU) will be analyzed in the hospital biochemistry laboratory using routine methods at the beginning of the study from blood samples taken by a nurse after at least 12 hours of fasting and without consuming alcohol for 24 hours before.

  4. Biochemical Measurements - CRP

    Time frame: at the beginning the study 1 times

    Participants' c-reactive protein tests (CRP) (mg/L) will be analyzed in the hospital biochemistry laboratory using routine methods at the beginning of the study from blood samples taken by a nurse after at least 12 hours of fasting and without consuming alcohol for 24 hours before.

  5. Anthropometric Measurements - Body weight (kg)

    Time frame: at the beginning the study 1 times

    At the beginning and end of the study, body weights (kg) will be measured using a bioelectrical impedance (BIA) device with a sensitivity of 50 grams in accordance with the measurement standards.

  6. Anthropometric Measurements - Height

    Time frame: at the beginning the study 1 times

    Height (cm) will be measured with a stadiometer in the Frankfort plane, standing and with the head upright.

  7. Body Mass Index

    Time frame: at the beginning the study 1 times

    The body mass index (BMI) of the participants will calculated according to the body weight (kg) / height (m)2 formula.

  8. Body Mass Index Classification

    Time frame: at the beginning the study 1 times

    The body mass index (BMI) of the participants is classified according to the World Health Organization (WHO) criteria. BMI ≤ 18.5 kg/m2 is underweight, between 18.5-24.99 kg/m2 is normal, ≥ 25 kg/m2 is overweight, and ≥ 30 kg/m2 is obese.

  9. Anthropometric Measurements - Fat Mass

    Time frame: at the beginning the study 1 times

    At the beginning and end of the study, body fat mass (kg) analysis will be performed using a bioelectrical impedance (BIA) device, paying attention to measurement standards.

  10. Anthropometric Measurements - Fat ratio calculation

    Time frame: at the beginning the study 1 times

    At the beginning and end of the study, body composition analyses will be performed using a bioelectrical impedance (BIA) device with measurement standards. According to the BIA analysis, fat percentage (%) will be calculated as the ratio of total body fat weight to total body weight.

  11. Anthropometric Measurements - Fat-free mass

    Time frame: at the beginning the study 1 times

    At the beginning and end of the study, fat-free mass (kg) will be analyzed using a bioelectrical impedance (BIA) device, paying attention to measurement standards.

  12. Anthropometric Measurements - Muscle mass

    Time frame: at the beginning the study 1 times

    At the beginning and end of the study, lean muscle mass (kg) will be analyzed using a bioelectrical impedance (BIA) device, paying attention to measurement standards.

  13. Anthropometric Measurements - Total body water

    Time frame: at the beginning the study 1 times

    At the beginning and end of the study, total body water (kg) will be analyzed using a bioelectrical impedance (BIA) device, paying attention to measurement standards.

  14. Biochemical Measurements - HbA1c

    Time frame: at the beginning the study 1 times

    HbA1C will be analyzed in the hospital biochemistry laboratory using routine methods from blood samples taken by a nurse at the beginning of the study.

  15. Biochemical Measurements - Fasting Insulin

    Time frame: at the beginning of the study

    Fasting insulin levels (IU) will be analyzed in the hospital biochemistry laboratory using routine methods from blood samples taken by a nurse at the beginning of the study.

  16. Biochemical Measurements - Urea

    Time frame: at the beginning of the study 1 times

    The blood urea (mg/dL) will be analyzed in the hospital biochemistry laboratory using routine methods from blood samples taken by a nurse at the beginning of the study.

  17. Biochemical Measurements - Serum Albumine

    Time frame: at the beginning of the study 1 times

    Serum Albumine (mg/dL) will be analyzed in the hospital biochemistry laboratory using routine methods from blood samples taken by a nurse at the beginning of the study.

  18. Biochemical Measurements - TSH

    Time frame: at the beginning of the study 1 times

    TSH (mUI/mL) will be analyzed in the hospital biochemistry laboratory using routine methods from blood samples taken by a nurse at the beginning of the study.

  19. Biochemical Measurements - Free T4

    Time frame: at the beginning of the study 1 times

    Free T4 (ng/dl) will be analyzed in the hospital biochemistry laboratory using routine methods from blood samples taken by a nurse at the beginning of the study.

  20. Biochemical Measurements - Serum Electrolyte Level

    Time frame: at the beginning of the study 1 times

    Serum sodium, potassium and calcium (mg/dL) will be analyzed in the hospital biochemistry laboratory using routine methods from blood samples taken by a nurse at the beginning of the study.

  21. Biochemical Measurements - Creatinine

    Time frame: at the beginning of the study 1 times

    Creatinine levels (mg/dL) will be analyzed in the hospital biochemistry laboratory using routine methods from blood samples taken by a nurse at the beginning of the study.

  22. Biochemical Measurements - White blood cell (WBC)

    Time frame: at the beginning of the study

    The white blood cell levels (mcL) will be analyzed in the hospital biochemistry laboratory using routine methods from blood samples taken by a nurse at the beginning of the study.

  23. Biochemical Measurements - Neutrophil count (NEU)

    Time frame: at the beginning of the study

    Neutrophil count (NEU) (mcL) will be analyzed in the hospital biochemistry laboratory using routine methods from blood samples taken by a nurse at the beginning of the study.

  24. Biochemical Measurements - Platelet (PLT)

    Time frame: at the beginning of the study

    Neutrophil count (NEU) (mL) will be analyzed in the hospital biochemistry laboratory using routine methods from blood samples taken by a nurse at the beginning of the study.

  25. Biochemical Measurements - Lymphocyte count (LYM)

    Time frame: at the beginning of the study 1 times

    Lymphocyte count (LYM) (mcL) will be analyzed in the hospital biochemistry laboratory using routine methods from blood samples taken by a nurse at the beginning of the study.

  26. Biochemical Measurements - Systemic Immune Inflammation Index (SII)

    Time frame: at the beginning of the study

    Systemic Immune Inflammation Index (SII) will calculates Platelet count X Neutrophil count/Lymphocyte count.

  27. Prognostic Inflammatory Index (PNI)

    Time frame: at the beginning of the study

    Prognostic Inflammatory Index (PNI) will calculated formula "10 × Serum Albumin (g/dL) + (0.005 × Total Lymphocyte Count (/mm³))".

  28. The dietary inflammatory index

    Time frame: 3 days

    The dietary inflammatory index will be calculated from individuals' 24-hour food consumption averages. The dietary inflammatory index will be calculated as a total of 1,000 calories, taking into account the dietary inflammatory load of the foods consumed. In this study, the dietary inflammatory index will be calculated for a total of 27 food items.

Secondary outcomes

  1. Food Consumption Record

    Time frame: 3 days

    The food consumption record will be taken to evaluate the nutritional status of the participants. Food consumption records will be evaluated in the BeBIS (Nutrition Information System) program and the daily energy (kcal) intake will be calculated.

  2. Food Consumption Record

    Time frame: 3 days

    The food consumption record will be taken to evaluate the nutritional status of the participants. Food consumption records will be evaluated in the BeBIS (Nutrition Information System) program and the daily carbohydrate (g), protein (g), fat (g), saturated fat (g), monounsaturated fatty acid (g), polyunsaturated fatty acid (g), omega-3 fatty acids (g), omega-6 fatty acids (g), and fiber (g) intake will be calculated.

  3. Food Consumption Record

    Time frame: 3 days

    The food consumption record will be taken to evaluate the nutritional status of the participants. Food consumption records will be evaluated in the BeBIS (Nutrition Information System) program and the daily vitamin E (mg), thiamine (mg), riboflavine (mg), niacin (mg), vitamine B5 (mg), vitamin B6 (mg), vitamin C, sodium (mg), potassium (mg), calcium (mg), magnesium (mg), phosphor (mg), iron (mg), zinc (mg), copper (mg), cholesterol (mg) intake will be calculated.

  4. Bristol Stool Form Scale

    Time frame: at the beginning of the study

    The Bristol Stool Form Scale, developed by Lewis and Heaton in Bristol, England, is a subjective scale used to assess an individual's stool consistency and bowel habits. This scale assesses defecation status in seven groups: Type 1 and Type 2 constipation; Type 3, Type 4, and Type 5 normal defecation; and Type 6 and Type 7 diarrhea. The form will be asked to participants.

  5. Gastrointestinal Symptom Assessment Scale

    Time frame: at the beginning of the study

    Developed by Revicki and colleagues and validated for Turkish by Turan et al., the GSRS is used to assess common symptoms of gastrointestinal disorders. The GSRS asks how an individual has felt about gastrointestinal issues over the past week. The scale consists of 15 questions, divided into five subscales: diarrhea (3 questions), dyspepsia (4 questions), constipation (3 questions), abdominal pain (3 questions), and reflux (2 questions). The higher the score, the more severe the gastrointestinal symptoms.

Sponsors and collaborators

Lead sponsor

Istanbul Bilgi University

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Dec 19, 2025
Registry last updated
Jul 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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