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

December 7, 2025 updated by: Hande Seven Avuk, Istanbul Bilgi University

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.

Study Overview

Study Type

Observational

Enrollment (Estimated)

70

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Uskudar
      • Istanbul, Uskudar, Turkey (Türkiye)
        • Istanbul Bilgi University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Aktif International Uskudar Hospital, Istanbul, Türkiye.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
at the beginning the study 1 times
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.
at the beginning the study 1 times
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.
at the beginning the study 1 times
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.
at the beginning the study 1 times
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.
at the beginning the study 1 times
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.
at the beginning the study 1 times
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.
at the beginning the study 1 times
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.
at the beginning the study 1 times
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.
at the beginning the study 1 times
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.
at the beginning the study 1 times
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.
at the beginning the study 1 times
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.
at the beginning the study 1 times
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.
at the beginning the study 1 times
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.
at the beginning the study 1 times
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.
at the beginning of the study
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.
at the beginning of the study 1 times
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.
at the beginning of the study 1 times
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.
at the beginning of the study 1 times
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.
at the beginning of the study 1 times
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.
at the beginning of the study 1 times
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.
at the beginning of the study 1 times
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.
at the beginning of the study
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.
at the beginning of the study
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.
at the beginning of the study
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.
at the beginning of the study 1 times
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.
at the beginning of the study
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))".
at the beginning of the study
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.
3 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 days
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 days
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.
3 days
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.
at the beginning of the study
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.
at the beginning of the study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Hande Seven Avuk, Ph.D., Istanbul Bilgi University
  • Principal Investigator: Gökben Anıl, Halic University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2025

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

July 30, 2026

Study Registration Dates

First Submitted

December 7, 2025

First Submitted That Met QC Criteria

December 7, 2025

First Posted (Actual)

December 19, 2025

Study Record Updates

Last Update Posted (Actual)

December 19, 2025

Last Update Submitted That Met QC Criteria

December 7, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • BARINFLAMMATION

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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