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

NCT07293624 | Enrolling By Invitation

• 1 other identifier: BARINFLAMMATION
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Bariatric Surgery; Bariatric Sleeve Gastrectomy; Inflamation; Systemic Inflammation; Dietary Inflammatory Index (DII); Systemic Inflammation Markers

Keywords

sleeve gastrectomy; diatary inflammation; bariatric surgery; systemic inflammation

Outcome Measures

Primary Outcomes (28)

• Biochemical Measurements - Fasting blood glucose

  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.

  at the beginning the study 1 times

• Biochemical Measurement - Lipid Profile

  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.

  at the beginning the study 1 times

• Biochemical Measurements - Liver Enzymes

  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.

  at the beginning the study 1 times

• Biochemical Measurements - CRP

  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.

  at the beginning the study 1 times

• Anthropometric Measurements - Body weight (kg)

  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.

  at the beginning the study 1 times

• Anthropometric Measurements - Height

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

  at the beginning the study 1 times

• Body Mass Index

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

  at the beginning the study 1 times

• Body Mass Index Classification

  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.

  at the beginning the study 1 times

• Anthropometric Measurements - Fat Mass

  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.

  at the beginning the study 1 times

• Anthropometric Measurements - Fat ratio calculation

  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.

  at the beginning the study 1 times

• Anthropometric Measurements - Fat-free mass

  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.

  at the beginning the study 1 times

• Anthropometric Measurements - Muscle mass

  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.

  at the beginning the study 1 times

• Anthropometric Measurements - Total body water

  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.

  at the beginning the study 1 times

• Biochemical Measurements - HbA1c

  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.

  at the beginning the study 1 times

• Biochemical Measurements - Fasting Insulin

  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.

  at the beginning of the study

• Biochemical Measurements - Urea

  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.

  at the beginning of the study 1 times

• Biochemical Measurements - Serum Albumine

  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.

  at the beginning of the study 1 times

• Biochemical Measurements - TSH

  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.

  at the beginning of the study 1 times

• Biochemical Measurements - Free T4

  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.

  at the beginning of the study 1 times

• Biochemical Measurements - Serum Electrolyte Level

  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.

  at the beginning of the study 1 times

• Biochemical Measurements - Creatinine

  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.

  at the beginning of the study 1 times

• Biochemical Measurements - White blood cell (WBC)

  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.

  at the beginning of the study

• Biochemical Measurements - Neutrophil count (NEU)

  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.

  at the beginning of the study

• Biochemical Measurements - Platelet (PLT)

  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.

  at the beginning of the study

• Biochemical Measurements - Lymphocyte count (LYM)

  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.

  at the beginning of the study 1 times

• Biochemical Measurements - Systemic Immune Inflammation Index (SII)

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

  at the beginning of the study

• Prognostic Inflammatory Index (PNI)

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

  at the beginning of the study

• The dietary inflammatory index

  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.

  3 days

Secondary Outcomes (5)

• Food Consumption Record

  3 days

• Food Consumption Record

  3 days

• Food Consumption Record

  3 days

• Bristol Stool Form Scale

  at the beginning of the study

• Gastrointestinal Symptom Assessment Scale

  at the beginning of the study

Interventions

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.

Eligibility Criteria

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

Study Population

Aktif International Uskudar Hospital, Istanbul, Türkiye.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Istanbul Bilgi University: lead

Study Sites (1)

Istanbul Bilgi University

Istanbul, Uskudar, Turkey (Türkiye)

Location

Study Officials

• Hande Seven Avuk, Ph.D.

  Istanbul Bilgi University

  PRINCIPAL INVESTIGATOR

• Gökben Anıl

  Haliç University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Head of Nutrition and Dietetic Department

Study Record Dates

• First Submitted: December 7, 2025
• First Posted: December 19, 2025
• Study Start: December 1, 2025
• Primary Completion: June 1, 2026
• Study Completion (Estimated): July 30, 2026
• Last Updated: December 19, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)