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Bariatric SurgeryNCT07293624

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

An observational study of Bariatric Surgery and Bariatric Sleeve Gastrectomy, run by Istanbul Bilgi University at 1 site in Turkey (Türkiye).

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years
What is being tested?
Observational Intervention and Observetional
How many people
70 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Dec 2025to 30 Jul 2026
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Aktif International Uskudar Hospital, Istanbul, Türkiye.

Who may be able to join

  • 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.

Who cannot join

  • 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,
Show all 11Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Turkey (Türkiye)1 site
  • Istanbul Bilgi University

    Istanbul, Uskudar

Other trials in Turkey (Türkiye)

About this study

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:

Read more

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.

Being tested
Observational Intervention, Observetional
Keywords
sleeve gastrectomy, diatary inflammation, bariatric surgery, systemic inflammation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Observational InterventionOther

    This is cross sectional observational study.

  • ObservetionalOther

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

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Biochemical Measurements - Fasting blood glucose

    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.

    Measured: at the beginning the study 1 times

  2. Biochemical Measurement - Lipid Profile

    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.

    Measured: at the beginning the study 1 times

  3. Biochemical Measurements - Liver Enzymes

    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.

    Measured: at the beginning the study 1 times

  4. Biochemical Measurements - CRP

    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.

    Measured: at the beginning the study 1 times

  5. Anthropometric Measurements - Body weight (kg)

    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.

    Measured: at the beginning the study 1 times

  6. Anthropometric Measurements - Height

    Height (cm) will be measured with a stadiometer in the Frankfort plane, standing and with the head upright.

    Measured: at the beginning the study 1 times

  7. Body Mass Index

    The body mass index (BMI) of the participants will calculated according to the body weight (kg) / height (m)2 formula.

    Measured: at the beginning the study 1 times

  8. Body Mass Index Classification

    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.

    Measured: at the beginning the study 1 times

  9. Anthropometric Measurements - Fat Mass

    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.

    Measured: at the beginning the study 1 times

  10. Anthropometric Measurements - Fat ratio calculation

    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.

    Measured: at the beginning the study 1 times

  11. Anthropometric Measurements - Fat-free mass

    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.

    Measured: at the beginning the study 1 times

  12. Anthropometric Measurements - Muscle mass

    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.

    Measured: at the beginning the study 1 times

  13. Anthropometric Measurements - Total body water

    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.

    Measured: at the beginning the study 1 times

  14. Biochemical Measurements - HbA1c

    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.

    Measured: at the beginning the study 1 times

  15. Biochemical Measurements - Fasting Insulin

    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.

    Measured: at the beginning of the study

  16. Biochemical Measurements - Urea

    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.

    Measured: at the beginning of the study 1 times

  17. Biochemical Measurements - Serum Albumine

    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.

    Measured: at the beginning of the study 1 times

  18. Biochemical Measurements - TSH

    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.

    Measured: at the beginning of the study 1 times

  19. Biochemical Measurements - Free T4

    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.

    Measured: at the beginning of the study 1 times

  20. Biochemical Measurements - Serum Electrolyte Level

    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.

    Measured: at the beginning of the study 1 times

  21. Biochemical Measurements - Creatinine

    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.

    Measured: at the beginning of the study 1 times

  22. Biochemical Measurements - White blood cell (WBC)

    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.

    Measured: at the beginning of the study

  23. Biochemical Measurements - Neutrophil count (NEU)

    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.

    Measured: at the beginning of the study

  24. Biochemical Measurements - Platelet (PLT)

    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.

    Measured: at the beginning of the study

  25. Biochemical Measurements - Lymphocyte count (LYM)

    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.

    Measured: at the beginning of the study 1 times

  26. Biochemical Measurements - Systemic Immune Inflammation Index (SII)

    Systemic Immune Inflammation Index (SII) will calculates Platelet count X Neutrophil count/Lymphocyte count.

    Measured: at the beginning of the study

  27. Prognostic Inflammatory Index (PNI)

    Prognostic Inflammatory Index (PNI) will calculated formula "10 × Serum Albumin (g/dL) + (0.005 × Total Lymphocyte Count (/mm³))".

    Measured: at the beginning of the study

  28. The dietary inflammatory index

    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.

    Measured: 3 days

Secondary outcomes (5)
  1. Food Consumption Record

    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.

    Measured: 3 days

  2. Food Consumption Record

    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.

    Measured: 3 days

  3. Food Consumption Record

    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.

    Measured: 3 days

  4. Bristol Stool Form Scale

    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.

    Measured: at the beginning of the study

  5. Gastrointestinal Symptom Assessment Scale

    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.

    Measured: at the beginning of the study

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Dec 2025
  2. Study start1 Dec 2025
  3. Primary completion30 Jul 2026 (estimated)
  4. Study completion30 Jul 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Cross-sectional
Enrolment
70 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07293624
Sponsor's protocol ID
BARINFLAMMATION
Status last verified
Jul 2026
First submitted
7 Dec 2025
Last updated
10 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Bariatric Surgery and Bariatric Sleeve Gastrectomy, run by Istanbul Bilgi University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: enrolling by invitation, as of the sponsor's last update on 10 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Biochemical Measurements - Fasting blood glucose (time frame: at the beginning the study 1 times). The study lists 28 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2026.

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