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Enrolling by invitation NCT07293624

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

— Observational Bariatric Surgery Bariatric Sleeve Gastrectomy Inflamation Systemic Inflammation

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
The protocol lists: Observational Intervention, Observetional.
Who it may be relevant to
Registry conditions: Bariatric Surgery, Bariatric Sleeve Gastrectomy, Inflamation, Systemic Inflammation. 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 →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

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

Primary outcome measures

  • Biochemical Measurements - Fasting blood glucose [Time frame: at the beginning the study 1 times]
  • Biochemical Measurement - Lipid Profile [Time frame: at the beginning the study 1 times]
  • Biochemical Measurements - Liver Enzymes [Time frame: at the beginning the study 1 times]
  • Biochemical Measurements - CRP [Time frame: at the beginning the study 1 times]
  • Anthropometric Measurements - Body weight (kg) [Time frame: at the beginning the study 1 times]
  • Anthropometric Measurements - Height [Time frame: at the beginning the study 1 times]
  • Body Mass Index [Time frame: at the beginning the study 1 times]
  • Body Mass Index Classification [Time frame: at the beginning the study 1 times]
  • Anthropometric Measurements - Fat Mass [Time frame: at the beginning the study 1 times]
  • Anthropometric Measurements - Fat ratio calculation [Time frame: at the beginning the study 1 times]
Secondary outcome measures (5)
  • Food Consumption Record [Time frame: 3 days]
  • Food Consumption Record [Time frame: 3 days]
  • Food Consumption Record [Time frame: 3 days]
  • Bristol Stool Form Scale [Time frame: at the beginning of the study]
  • Gastrointestinal Symptom Assessment Scale [Time frame: at the beginning of the study]

Eligibility criteria

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.

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
Other

Study locations

Turkey (Türkiye) · 1 center
  • Istanbul Bilgi University — Istanbul

Identifiers

NCT: NCT07293624 · BARINFLAMMATION

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗