ClinicalTrials.gg
Enrolling by invitationNCT07293624Updated Jul 10, 2026

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

An observational study in Bariatric Surgery, Bariatric Sleeve Gastrectomy and Inflamation, sponsored by Istanbul Bilgi University. Enrolling by invitation at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-07-10.

Sponsored by Istanbul Bilgi University · Observational

From the registry’s dates

  • Primary completion was expected by Jul 2026, 3 months ago, but the record still lists the study as enrolling by invitation.
Study type
Observational
Model
Other
Time perspective
Cross-sectional
Enrollment
70
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

02

Conditions studied

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

Keywords

  • sleeve gastrectomy
  • diatary inflammation
  • bariatric surgery
  • systemic inflammation
03

In context

Lead sponsor

Istanbul Bilgi University is the lead sponsor of 52 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Aktif International Uskudar Hospital, Istanbul, Türkiye.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 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

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 disease, active infection, or cancer,
  • Individuals regularly taking medications that could affect inflammation levels, such as , , 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.
Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

05

Study design

Observational model
Other
Time perspective
Cross-sectional
Enrollment
70 participants (estimated)
Patient registry
No

Interventions

  • OtherObservational Intervention

    This is cross sectional observational study.

  • OtherObservetional

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

06

What researchers measure

Primary outcomes

  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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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))".

    Time frame: 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.

    Time frame: 3 days

Secondary outcomes

  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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: at the beginning of the study

07

Study locations

1 site
  • Istanbul Bilgi University
    Istanbul, Uskudar, Turkey (Türkiye)
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 10, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07293624
Lead sponsor
Istanbul Bilgi University
Responsible party
Hande Seven Avuk (Assistant Professor, Head of Nutrition and Dietetic Department, Istanbul Bilgi University) — Principal investigator
First posted
Dec 19, 2025
Start date
Dec 1, 2025
Primary completion
Jul 30, 2026 (estimated)
Completion
Jul 30, 2026 (estimated)
Last update
Jul 10, 2026

Study contacts

Hande Seven Avuk, Ph.D.
principal investigator · Istanbul Bilgi University
Gökben Anıl
principal investigator · Haliç University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

No contact was published for this record. The registry link below has the sponsor’s details.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion