Inflammatory Bowel Disease (IBD)Public healthNCT07179965
Nutrition, Meal Regularity and Quality of Life in Inflammatory Bowel Disease
A study testing Observation in people with Inflammatory Bowel Disease (IBD) and Inflammation, run by Istinye University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Inflammatory Bowel Disease (IBD), Inflammation, Nutrition
- What is being tested?
- Observation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Aug 2023to 5 Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Inclusion criteria required the ability to communicate effectively and make independent dietary choices.
Who cannot join
- Individuals with psychiatric disorders, or those who were pregnant or breastfeeding, were excluded.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Being tested
- Observation
- Keywords
- Inflammatory Bowel Disease, Nutrition, Diet, Meal regularity
- Medical subject headings
- Inflammatory Bowel Diseases, Inflammation, Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObservationOther
IBD patients
| Study group | Role | What they receive |
|---|---|---|
| Inflammatory Bowel Disease patients | Other | Not described Receives: Other: Observation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight
kg
Measured: Baseline
Height
cm
Measured: Baseline
24-Hour Dietary Recall
Measured: 24-Hour Dietary Recall
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.
Measured: Baseline
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).
Measured: Baseline
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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2025
- Study start1 Aug 2023
- Primary completion30 Sep 2023
- Study completion5 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Inflammatory Bowel Disease (IBD)Studies of the same condition, open and under way.
- More trials run by Istinye UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Cross sectional
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istinye University
- Sponsor type
- University, hospital or other
- Collaborators
- Istanbul University - Cerrahpasa
- Responsible party
- Principal investigator, Elif Nur Özen, Istinye University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07179965
- Sponsor's protocol ID
- IstinyeElif1
- Other IDs
- No funding
- Acronym
- Public health
- Status last verified
- Sep 2025
- First submitted
- 4 Sep 2025
- Last updated
- 18 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nutrition, Meal Regularity and Quality of Life in Inflammatory Bowel Disease
- ClinicalTrials.gov ID
- NCT07179965
- Acronym / sponsor ID
- Public health / IstinyeElif1
- Keywords
- Inflammatory Bowel Disease, Nutrition, Diet, Meal regularity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Istinye UniversityUniversity, hospital or other
- Collaborators
- Istanbul University - Cerrahpasa
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 30 Sep 2023 (actual)
- Study completion
- 5 Aug 2025 (actual)
- First posted
- 18 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Cross sectional
| Arm | Type | Receives |
|---|---|---|
| Inflammatory Bowel Disease patients | Other | Other: Observation |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Inclusion criteria required the ability to communicate effectively and make independent dietary choices.
Key exclusion criteria (1 listed)
- Individuals with psychiatric disorders, or those who were pregnant or breastfeeding, were excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ObservationIBD patients | Other | Inflammatory Bowel Disease patients |
Primary outcome
Weight
Time frame: Baseline
kg
Height
Time frame: Baseline
cm
24-Hour Dietary Recall
Time frame: 24-Hour Dietary Recall
IBD Quality of Life Questionnaire
Time frame: Baseline
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.
Beck Depression Inventory II
Time frame: Baseline
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).
Gastrointestinal Symptom Rating Scale
Time frame: Baseline
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2025.
- Results publication: PubMed 38525407Alavinejad 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.
- Individual participant dataSharing planned: No
Related trials for Inflammatory Bowel Disease (IBD)
Not yet recruitingPhase 1
An Open-label, DDI Study to Investigate the Effects of Duvakitug on the PK of Selected Cytochrome P450 Substrates
Ulcerative Colitis, Crohn's Disease
RecruitingObservational study
Longitudinal Immunophenotyping of Patients With Inflammatory Bowel Disease
Inflammatory Bowel Disease, Crohn's Disease
RecruitingObservational study
Ibd CAncer and seRious Infections in France (I-CARE 2)
IBD, Ulcerative Colitis
Recruiting
Effect of Mediterranean Diet in Inflammatory Bowel Disease
Inflammatory Bowel Disease
RecruitingObservational study
Characterization of Colorectal Dysplasic Lesions and Stratification of Their Evolving Risk in Inflammatory Bowel Disease Patients: a Prospective, Observational and Multicenter Study
Crohn Disease (CD), Colitis Ulcerative
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Observation in people with Inflammatory Bowel Disease (IBD) and Inflammation, run by Istinye 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 18 Sep 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Weight (time frame: Baseline). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07179965, which also lists 1 linked publication.
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 18 Sep 2025.