- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07293624
Effects of the Dietary Inflammatory Index on Systemic Inflammation Markers and Gastrointestinal Symptoms in Individuals With Bariatric Surgery
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
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Locations
-
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Uskudar
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Istanbul, Uskudar, Turkey (Türkiye)
- Istanbul Bilgi University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
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
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Biochemical Measurements - Fasting blood glucose
Time Frame: at the beginning the study 1 times
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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.
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at the beginning the study 1 times
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Biochemical Measurement - Lipid Profile
Time Frame: at the beginning the study 1 times
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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.
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at the beginning the study 1 times
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Biochemical Measurements - Liver Enzymes
Time Frame: at the beginning the study 1 times
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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.
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at the beginning the study 1 times
|
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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.
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at the beginning the study 1 times
|
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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.
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at the beginning the study 1 times
|
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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.
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at the beginning the study 1 times
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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.
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at the beginning the study 1 times
|
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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.
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at the beginning the study 1 times
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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.
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at the beginning the study 1 times
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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.
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at the beginning the study 1 times
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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.
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at the beginning the study 1 times
|
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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.
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at the beginning the study 1 times
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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.
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at the beginning the study 1 times
|
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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.
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at the beginning the study 1 times
|
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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.
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at the beginning of the study
|
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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.
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at the beginning of the study 1 times
|
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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.
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at the beginning of the study 1 times
|
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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.
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at the beginning of the study 1 times
|
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Biochemical Measurements - Free T4
Time Frame: at the beginning of the study 1 times
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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.
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at the beginning of the study 1 times
|
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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.
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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.
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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.
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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.
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at the beginning of the study
|
|
Biochemical Measurements - Lymphocyte count (LYM)
Time Frame: at the beginning of the study 1 times
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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.
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at the beginning of the study 1 times
|
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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.
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at the beginning of the study
|
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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))".
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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.
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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.
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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.
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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.
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at the beginning of the study
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Hande Seven Avuk, Ph.D., Istanbul Bilgi University
- Principal Investigator: Gökben Anıl, Halic University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
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)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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