Effects of the Dietary Inflammatory Index on Systemic Inflammation Markers and Gastrointestinal Symptoms in Individuals With Bariatric Surgery
Trial Snapshot
- Phase
- Not Applicable
- Status
- Enrolling By Invitation
- Sponsor
- Istanbul Bilgi University
- Enrollment
- 70
- Locations
- 1
- Primary Endpoint
- Biochemical Measurements - HbA1c
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Other
- Time Perspective
- Cross Sectional
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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.
Outcomes
Primary Outcomes
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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))".
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
- 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)
Investigators
Hande Seven Avuk
Assistant Professor, Head of Nutrition and Dietetic Department
Istanbul Bilgi University