Celiac DiseaseNCT06402734
Effects of Gluten-Free Diet on Nutritional Status in Celiac Patients
An observational study of Celiac Disease, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
This study examined the impact of a gluten-free diet on nutritional status and inflammation markers in adult celiac patients compared to a control group. Twenty-six celiac patients and 26 healthy individuals participated. Interviews, dietary records, anthropometric measurements, and blood samples were collected. Read more about this study
- Who is it for?
- Ages 19 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Celiac Disease
- What is being tested?
- Adherence to Gluten Free Diet
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 52 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Oct 2018to 15 Mar 2020
- Phase
- Observational
- 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 19 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: The study population consisted of 26 individuals diagnosed with celiac disease, comprising 21 females and 5 males, aged between 18 and 64 years. Additionally, a healthy control group of 26 individuals, including 20 females and 6 males, without any known diseases, was included in the study.
Who may be able to join
- Adults aged between 19 and 64 years old.
- Diagnosis of celiac disease.
- Willingness to participate in the study.
- Ability to adhere to the study protocol, including dietary restrictions and follow-up assessments.
- For the control group, individuals without celiac disease or any other significant health conditions.
Who cannot join
- Individuals following diets other than a gluten-free diet.
- Individuals adhering to a gluten-free diet for reasons other than celiac disease.
- Individuals with gastrointestinal diseases other than celiac disease.
- Individuals who have undergone gastrointestinal surgery.
- Individuals with mental illnesses.
- Cancer patients.
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- Individuals positive for hepatitis B surface antigen or anti-hepatitis C virus antibody.
- Individuals using interferon and/or insulin.
- Pregnant or lactating women.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Hacettepe University Nutrition and Dietetics Department
Ankara, 06100
About this study
Official title: Effects of Gluten-Free Diet on Nutritional Status and Inflammation Parameters in Adult Celiac Patients
This study examined the impact of a gluten-free diet on nutritional status and inflammation markers in adult celiac patients compared to a control group. Twenty-six celiac patients and 26 healthy individuals participated. Interviews, dietary records, anthropometric measurements, and blood samples were collected. After six weeks, celiac patients showed improved adherence to the gluten-free diet and increased quality of life scores. While initial micronutrient intake was lower in celiac patients, it improved over the study period. However, there were no significant changes in inflammation markers.
Read the detailed description
This study aimed to examine the effects of a gluten-free diet on the nutritional status, anthropometric measurements, and serum levels of interferon-gamma (IFN-γ) and interleukin-15 (IL-15) in adult celiac patients, comparing them with a control group. A total of 26 celiac patients aged 18-64 years and 26 healthy individuals as the control group were included. Face-to-face interviews were conducted to determine participants\' general characteristics, dietary habits, and physical activity status. Additionally, a retrospective 24-hour dietary recall and food frequency questionnaire were administered to assess dietary intake. Anthropometric measurements and blood samples were collected during the interviews. Celiac patients received education about the gluten-free diet, and follow-up assessments were conducted six weeks later. At the beginning, 53.8% of celiac patients reported always/mostly adhering to the gluten-free diet, which increased to 100.0% after six weeks. The total quality of life scores significantly increased in celiac patients after six weeks. Initial serum IL-15 levels were similar between celiac and control groups, whereas serum IFN-γ levels were significantly higher in celiac patients compared to the control group.
- Conditions
- Celiac Disease
- Being tested
- Adherence to Gluten Free Diet
- Keywords
- celiac disease, inflammation, interferon-gamma, interleukin-15
- Medical subject headings
- Celiac Disease, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adherence to Gluten Free DietBehavioural
Participants with a diagnosed celiac disease were following a gluten-free diet. Study observed the adherence to the gluten-free diet for 6 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Celiac Disease | Adult patients who were diagnosed with celiac disease were enrolled in the study. Receives: Behavioral: Adherence to Gluten Free Diet | |
| Healthy Subjects | Healthy subjects with matching demographical characteristics to the celiac group were enrolled in the study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum interferon-gamma level
Serum interferon-gamma level was measured.
Measured: 6 weeks
Serum interleukin-15 levels
Serum interleukin-15 level was measured.
Measured: 6 weeks
Body weight
Body weight was measured using body composition analyzer device.
Measured: 6 weeks
Lean body mass
Lean body mass was measured using body composition analyzer device.
Measured: 6 weeks
Secondary outcomes (1)
Total energy intake
Total energy intake was measured using food records.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2024
- Study start15 Oct 2018
- Primary completion15 Jan 2020
- Study completion15 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Celiac DiseaseStudies of the same condition, open and under way.
- More trials run by Hacettepe 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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zeynep Goktas, Hacettepe University
- Investigators
- Zeynep Goktas, PhD, Principal investigator, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06402734
- Sponsor's protocol ID
- GO 18/760
- Status last verified
- May 2024
- First submitted
- 3 May 2024
- Last updated
- 7 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Due to the ethical reasons participant data will not be shared.
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Gluten-Free Diet on Nutritional Status and Inflammation Parameters in Adult Celiac Patients
- ClinicalTrials.gov ID
- NCT06402734
- Acronym / sponsor ID
- GO 18/760
- Conditions
- Celiac Disease
- Keywords
- celiac disease, inflammation, interferon-gamma, interleukin-15
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 15 Oct 2018 (actual)
- Primary completion
- 15 Jan 2020 (actual)
- Study completion
- 15 Mar 2020 (actual)
- First posted
- 7 May 2024 (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.
This study examined the impact of a gluten-free diet on nutritional status and inflammation markers in adult celiac patients compared to a control group. Twenty-six celiac patients and 26 healthy individuals participated. Interviews, dietary records, anthropometric measurements, and blood samples were collected. After six weeks, celiac patients showed improved adherence to the gluten-free diet and increased quality of life scores. While initial micronutrient intake was lower in celiac patients, it improved over the study period. However, there were no significant changes in inflammation markers.
Detailed description
This study aimed to examine the effects of a gluten-free diet on the nutritional status, anthropometric measurements, and serum levels of interferon-gamma (IFN-γ) and interleukin-15 (IL-15) in adult celiac patients, comparing them with a control group. A total of 26 celiac patients aged 18-64 years and 26 healthy individuals as the control group were included. Face-to-face interviews were conducted to determine participants\' general characteristics, dietary habits, and physical activity status. Additionally, a retrospective 24-hour dietary recall and food frequency questionnaire were administered to assess dietary intake. Anthropometric measurements and blood samples were collected during the interviews. Celiac patients received education about the gluten-free diet, and follow-up assessments were conducted six weeks later. At the beginning, 53.8% of celiac patients reported always/mostly adhering to the gluten-free diet, which increased to 100.0% after six weeks. The total quality of life scores significantly increased in celiac patients after six weeks. Initial serum IL-15 levels were similar between celiac and control groups, whereas serum IFN-γ levels were significantly higher in celiac patients compared to the control group.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Celiac Disease | – | Behavioral: Adherence to Gluten Free DietAdult patients who were diagnosed with celiac disease were enrolled in the study. |
| Healthy Subjects | – | –Healthy subjects with matching demographical characteristics to the celiac group were enrolled in the study. |
Who may qualify
- Ages
- 19 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- The study population consisted of 26 individuals diagnosed with celiac disease, comprising 21 females and 5 males, aged between 18 and 64 years. Additionally, a healthy control group of 26 individuals, including 20 females and 6 males, without any known diseases, was included in the study.
Key inclusion criteria (5 listed)
- Adults aged between 19 and 64 years old.
- Diagnosis of celiac disease.
- Willingness to participate in the study.
- Ability to adhere to the study protocol, including dietary restrictions and follow-up assessments.
- For the control group, individuals without celiac disease or any other significant health conditions.
Key exclusion criteria (9 listed)
- Individuals following diets other than a gluten-free diet.
- Individuals adhering to a gluten-free diet for reasons other than celiac disease.
- Individuals with gastrointestinal diseases other than celiac disease.
- Individuals who have undergone gastrointestinal surgery.
- Individuals with mental illnesses.
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 |
|---|---|---|
| Adherence to Gluten Free DietParticipants with a diagnosed celiac disease were following a gluten-free diet. Study observed the adherence to the gluten-free diet for 6 weeks. | Behavioural | Celiac Disease |
Primary outcome
Serum interferon-gamma level
Time frame: 6 weeks
Serum interferon-gamma level was measured.
Serum interleukin-15 levels
Time frame: 6 weeks
Serum interleukin-15 level was measured.
Body weight
Time frame: 6 weeks
Body weight was measured using body composition analyzer device.
Lean body mass
Time frame: 6 weeks
Lean body mass was measured using body composition analyzer device.
1 secondary outcome
Total energy intake
Time frame: 6 weeks
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 7 May 2024.
- Individual participant dataSharing planned: No. Due to the ethical reasons participant data will not be shared.
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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.
Zeynep Goktas, PhD principal investigator
Hacettepe University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Celiac Disease, run by Hacettepe 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 5 inclusion and 9 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 7 May 2024. 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?
Serum interferon-gamma level (time frame: 6 weeks). The study lists 4 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 7 May 2024.