Istanbul Bilgi University
Istanbul, Uskudar, Turkey (Türkiye)
NCT Number: NCT07293624
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.
Interested in participating?
Request Info18 year–65 year
All sexes
Observational
Istanbul, Uskudar, Turkey (Türkiye)
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Time frame: at the beginning of the study
Systemic Immune Inflammation Index (SII) will calculates Platelet count X Neutrophil count/Lymphocyte count.
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))".
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.
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.
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.
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.
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.
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.
Istanbul Bilgi University
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