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

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

Status
Enrolling by invitation
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07293624
Enrollment
70
Registered
2025-12-19
Start date
2025-12-01
Completion date
2026-07-30
Last updated
2026-07-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

sleeve gastrectomy, diatary inflammation, bariatric surgery, systemic inflammation

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.

Interventions

This is cross sectional observational study.

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

Sponsors

Istanbul Bilgi University
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Biochemical Measurements - Fasting blood glucoseat the beginning the study 1 timesFasting 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.
Biochemical Measurement - Lipid Profileat the beginning the study 1 timesParticipants' 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.
Biochemical Measurements - Liver Enzymesat the beginning the study 1 timesParticipants' 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.
Biochemical Measurements - CRPat the beginning the study 1 timesParticipants' 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.
Anthropometric Measurements - Body weight (kg)at the beginning the study 1 timesAt 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.
Anthropometric Measurements - Heightat the beginning the study 1 timesHeight (cm) will be measured with a stadiometer in the Frankfort plane, standing and with the head upright.
Body Mass Indexat the beginning the study 1 timesThe body mass index (BMI) of the participants will calculated according to the body weight (kg) / height (m)2 formula.
Body Mass Index Classificationat the beginning the study 1 timesThe 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.
Anthropometric Measurements - Fat Massat the beginning the study 1 timesAt 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.
Anthropometric Measurements - Fat ratio calculationat the beginning the study 1 timesAt 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.
Anthropometric Measurements - Fat-free massat the beginning the study 1 timesAt 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.
Anthropometric Measurements - Muscle massat the beginning the study 1 timesAt 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.
Anthropometric Measurements - Total body waterat the beginning the study 1 timesAt 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.
Biochemical Measurements - HbA1cat the beginning the study 1 timesHbA1C will be analyzed in the hospital biochemistry laboratory using routine methods from blood samples taken by a nurse at the beginning of the study.
Biochemical Measurements - Fasting Insulinat the beginning of the studyFasting 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.
Biochemical Measurements - Ureaat the beginning of the study 1 timesThe 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.
Biochemical Measurements - Serum Albumineat the beginning of the study 1 timesSerum 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.
Biochemical Measurements - TSHat the beginning of the study 1 timesTSH (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.
Biochemical Measurements - Free T4at the beginning of the study 1 timesFree 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.
Biochemical Measurements - Serum Electrolyte Levelat the beginning of the study 1 timesSerum 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.
Biochemical Measurements - Creatinineat the beginning of the study 1 timesCreatinine 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.
Biochemical Measurements - White blood cell (WBC)at the beginning of the studyThe 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.
Biochemical Measurements - Neutrophil count (NEU)at the beginning of the studyNeutrophil 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.
Biochemical Measurements - Platelet (PLT)at the beginning of the studyNeutrophil 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.
Biochemical Measurements - Lymphocyte count (LYM)at the beginning of the study 1 timesLymphocyte 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.
Biochemical Measurements - Systemic Immune Inflammation Index (SII)at the beginning of the studySystemic Immune Inflammation Index (SII) will calculates Platelet count X Neutrophil count/Lymphocyte count.
Prognostic Inflammatory Index (PNI)at the beginning of the studyPrognostic Inflammatory Index (PNI) will calculated formula "10 × Serum Albumin (g/dL) + (0.005 × Total Lymphocyte Count (/mm³))".
The dietary inflammatory index3 daysThe 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

MeasureTime frameDescription
Food Consumption Record3 daysThe 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.
Bristol Stool Form Scaleat the beginning of the studyThe 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.
Gastrointestinal Symptom Assessment Scaleat the beginning of the studyDeveloped 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.

Countries

Turkey (Türkiye)

Contacts

PRINCIPAL_INVESTIGATORHande Seven Avuk, Ph.D.

Istanbul Bilgi University

PRINCIPAL_INVESTIGATORGökben Anıl

Haliç University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 11, 2026