CClinicalTrials.gg
CompletedNCT07179965Public healthUpdated Sep 18, 2025

Nutrition, Meal Regularity and Quality of Life in Inflammatory Bowel Disease

An interventional study of Observation in Inflammatory Bowel Disease (IBD), Inflammation and Nutrition, sponsored by Istinye University. Completed at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-09-18.

Sponsored by Istinye University · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Registered 2 years 1 month after the study started (first participant enrolled Aug 2023, registered Sep 2025).
Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Not applicable
Ages
18 Years to 75 Years
Sex
All
01

Study summary

Aims: This study aimed to assess nutritional status, dietary habits, meal patterns, gastrointestinal symptoms, quality of life, and depression in Inflammatory Bowel Disease (IBD) patients.

Methods: Data were collected at a university hospital using the 24-Hour Dietary Recall, IBD Quality of Life Questionnaire, Beck Depression Inventory II, and the Gastrointestinal Symptom Rating Scale.

Read the detailed description

Inflammatory Bowel Disease (IBD), which is divided into Ulcerative Colitis and Crohn's Disease, is influenced by various environmental factors, including nutrition, and significantly reduces the quality of life. This study included 50 individuals aged 18-75 who were diagnosed with Inflammatory Bowel Disease by a physician, had no communication difficulties, and were able to make their own food choices. The study aimed to evaluate the nutritional status, dietary habits, food consumption frequencies, and meal patterns of the patients and, based on these data, to determine their gastrointestinal symptoms, quality of life, and depression status. The study commenced with ethical approval and was conducted with patients at the Gastroenterology Clinic of Istanbul University Cerrahpaşa Medical Faculty Hospital between August 2023 and September 2023. The research is cross-sectional. Data were collected using the General Information and Nutrition Behaviors Questionnaire, Food Frequency Questionnaire, 24-Hour Dietary Recall, Inflammatory Bowel Disease Quality of Life Questionnaire, Beck Depression Inventory, and Gastrointestinal Symptom Rating Scale.

02

Conditions studied

  • Inflammatory Bowel Disease (IBD)
  • Inflammation
  • Nutrition
  • Diet Habits
  • Gastrointestinal

Keywords

  • Inflammatory Bowel Disease
  • Nutrition
  • Diet
  • Meal regularity
03

In context

Inflammatory Bowel Diseases

1,460 studies on the registry are indexed under Inflammatory Bowel Diseases; 438 are open to participants now.

This study's enrollment of 50 is below the median of 70 across 770 interventional studies indexed under Inflammatory Bowel Diseases.

Browse Inflammatory Bowel Diseases studies →

Lead sponsor

Istinye University is the lead sponsor of 207 studies on the registry; 88 are open to participants now.

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

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Inclusion criteria required the ability to communicate effectively and make independent dietary choices.

Exclusion criteria

Exclusion Criteria:

  • Individuals with psychiatric disorders, or those who were pregnant or breastfeeding, were excluded.
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
50 participants (actual)

Study arms

  • Other
    Inflammatory Bowel Disease patients

    Other: Observation

Interventions

  • OtherObservation

    IBD patients

06

What researchers measure

Primary outcomes

  1. Weight

    kg

    Time frame: Baseline

  2. Height

    cm

    Time frame: Baseline

  3. 24-Hour Dietary Recall

    Time frame: 24-Hour Dietary Recall

  4. IBD Quality of Life Questionnaire

    To assess quality of life, the "Inflammatory Bowel Disease Quality of Life Questionnaire," consisting of 36 items and evaluating systemic symptoms, bowel symptoms, functional impairment, social impairment, and emotional functioning, was used. A higher score is associated with better quality of life.

    Time frame: Baseline

  5. Beck Depression Inventory II

    The Beck Depression Inventory-II (BDI-II), a 21-item self-report questionnaire assessing characteristic attitudes and symptoms of depression, was administered at baseline (single time point, at questionnaire administration). Each item is scored on a 4-point scale (0-3), with a total score range of 0-63. Higher scores indicate greater severity of depression, classified as minimal (0-13), mild (14-19), moderate (20-28), and severe (29-63).

    Time frame: Baseline

  6. Gastrointestinal Symptom Rating Scale

    The Gastrointestinal Symptom Rating Scale (GSRS), a 15-item questionnaire comprising five subcategories (abdominal pain, indigestion, diarrhea, constipation, and reflux), was administered at baseline (single time point, at questionnaire administration). Each item is scored on a 7-point Likert scale (1-7), yielding a total score range of 15-105, with higher scores indicating more severe gastrointestinal symptoms.

    Time frame: Baseline

07

Study locations

1 site
  • Istanbul University Cerrahpaşa
    Istanbul, Turkey (Türkiye)
08

References and documents

Publications

  • Alavinejad P, Hashemi SJ, Behl N, Hormati A, Elbasuny A, Daryani NE, Modarres MP, Arshadzadeh M, Panahande S, Hang DV, Mahros AM, Parsi A, Javaherizadeh H, Rehman A, Pawlak KM, Ahmadi M, Ahmed MH, Farsi F, Arefi M, Quadri A, Tran QT, Alborzi F, Amin Alavi SM, Cheraghian B, Ramezani E, Gouda MF, Saadati B, Quadri AA, Hirani R, Maher M, Ghoneem E. Inflammatory bowel disease evolution in the past two decades: a chronological multinational study. EClinicalMedicine. 2024 Mar 15;70:102542. doi: 10.1016/j.eclinm.2024.102542. eCollection 2024 Apr. PubMed 38525407 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 18, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07179965
Lead sponsor
Istinye University
Collaborators
Istanbul University - Cerrahpasa
Responsible party
Elif Nur Özen (Research Assistant, Istinye University) — Principal investigator
First posted
Sep 18, 2025
Start date
Aug 1, 2023
Primary completion
Sep 30, 2023
Completion
Aug 5, 2025
Last update
Sep 18, 2025

Oversight

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

Not currently enrolling

This study is completed, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.

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