Celiac DiseaseNCT06300164
The Effect of Unripe Carob Fruit in Celiac Patients
A study testing Unripre Carob in people with Celiac Disease, run by Toros University.
Trial summary
The aim of this study was to investigate the effects of the consumption of cookies produced by adding the unripe part of carob fruit, which has high insoluble fiber, polyphenol and antioxidant content, on the oxidative parameters (TAS and MDA), intestinal permeability (zonulin, GIP) and microbiota of celiac patients… Read more about this study
- Who is it for?
- Ages 19 to 64 years
- Conditions the study is for
- Celiac Disease
- What is being tested?
- Unripre Carob
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2024to 1 Jul 2024
- 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 19 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Have been diagnosed with celiac disease within a maximum period of 1 year,
- Have not received dietary treatment by a dietitian before
- Body Mass Index value between 18.5-25.0 kg/m2,
- Who have consumed carob fruit and have not had any allergies,
- Signed the Informed Consent Form,
- Between the ages of 19 and 64,
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- Who has not had gastrointestinal tract surgery,
- Without mental disorder,
- Without inflammatory disease,
- No antibiotics or probiotics for the last 1 month,
- Not taking prescription drugs and/or fiber supplements,
- Not taking vitamin, mineral supplements,
- Not during pregnancy and lactation,
- Without excessive alcohol consumption (>2 drinks/day)
Who cannot join
- Diagnosed with celiac disease for more than 1 year,
- Have gastrointestinal diseases other than celiac disease,
- Have previously received dietary treatment by a dietitian, following a diet other than a gluten-free diet,
- Body Mass Index values below 18.5 kg/m2 and above 25.0 kg/m2,
- Who have consumed carob fruit and have had any allergies,
- Not signing the Informed Volunteer Consent Form,
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- Not between the ages of 19-64,
- Gastrointestinal tract surgery,
- With a mental disorder,
- With inflammatory disease,
- Taking antibiotics or probiotics for the last 1 month,
- Taking prescription medication and/or fiber supplements,
- Taking vitamin and mineral supplements,
- During pregnancy and lactation,
- Excessive alcohol consumption (>2 drinks/day)
About this study
Official title: The Effect of Unripe Carob Fruit on Oxidative Markers and Intestinal Permeability and Microbiota in Celiac Patients
The aim of this study was to investigate the effects of the consumption of cookies produced by adding the unripe part of carob fruit, which has high insoluble fiber, polyphenol and antioxidant content, on the oxidative parameters (TAS and MDA), intestinal permeability (zonulin, GIP) and microbiota of celiac patients and to develop new products containing unripe carob fruit for celiac patients in this direction.
Read the detailed description
Between 01.02.2022 and 30.05.2022 by Specialist Dr. Orhan SEZGİN
The study will be conducted with 30 volunteers who present to the Mersin University Faculty of Medicine Hospital Gastroenterology Department in Mersin.
- Conditions
- Celiac Disease
- Being tested
- Unripre Carob
- Keywords
- Celiac, Unripe carob, Antioxidant, Microbiota
- Medical subject headings
- Celiac Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Unripre CarobDietary supplement
The standard cookies and test cookies (with carob addition) to be used in the study will be produced by Dr. Lecturer Özlem ÖZPAK AKKUŞ at Toros University Nutrition Principles Laboratory. Prof. Dr. Özlem ÖZPAK AKKUŞ will produce the cookies. For standard cookies, 1 egg, 325 g gluten-free flour (Söke flour), 75 grams butter, 50 grams sugar, 10 grams baking powder, 10 grams vanilla will be added and the prepared bread mixture will be divided into 50 equal parts. To make cookies with the addition of unripe carob, the same recipe as the standard cookie will be used to make the test cookie with the addition of unripe carob fruit flour, divided into 50 equal parts, and the amount of unripe carob fruit flour will be added by calculating the daily fiber consumption amount of the patients participating in the study to be 25 g.
| Study group | Role | What they receive |
|---|---|---|
| People with celiac disease who eat cookies with unripe carob - Experimental Group | Experimental | Individuals with celiac disease who met the inclusion criteria and participated in the study will divided into two groups by Specialist OrhN SEZGİN, and they will be asked to consume the cookies produced (in the preliminary study) produced as a standard (n=15) and with the addition of unripe carob (n=15) for eight weeks.
The individuals participating in the study will be asked not to change their eating habits, physical activity habits, and drug treatments during the study period. Each individual participating in the study will be provided with the required amount of cookie during the study and will be contacted weekly by Ecem GÜLÜŞEN, a dietitian, to verify whether they consume cookies regularly. Receives: Dietary Supplement: Unripre Carob |
| No intervention - Control Group | No intervention | Individuals with celiac disease will not eat unripe carob cookie |
What is being measured
The primary outcome is the main question the study is designed to answer.
Examination of between group differences regarding serum Total Antioxidant Capacity (TAC)
Examination of intergroup differences of the concentration of the serum total antioxidant capacity for the determination of antioxidant capacity status in celiac diseases
Measured: First day at the beginning of the study
Examination of between group differences regarding serum Malondialdehyde (MDA)
Examination of intergroup differences of the concentration of the serum malondialdehyde for the determination of oxidant capacity status in celiac diseases
Measured: First day at the beginning of the study
Examination of between group differences regarding serum zonulin
Examination of intergroup differences of the concentration of the serum zonulin for the determination of intestinal permeability in celiac diseases
Measured: First day at the beginning of the study
Secondary outcomes (3)
Comparison of between group differences regarding serum Total Antioxidant Capacity (TAC)
Comparison of between group differences of the concentration of the serum total antioxidant for the determination of antioxidant capacity status in celiac diseases
Measured: Eight weeks after the start of the study
Comparison of between group differences regarding serum Malondialdehyde (MDA)
Comparison of between group differences of the concentration of the serum malondialdehyde for the determination of oxidant capacity status in celiac diseases
Measured: Eight weeks after the start of the study
Comparison of between group differences regarding serum zonulin
Comparison of between group differences of the concentration of the serum zonulin for the determination of intestinal permeability in celiac diseases
Measured: Eight weeks after the start of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2024
- Study start1 Apr 2024 (estimated)
- Primary completion1 May 2024 (estimated)
- Study completion1 Jul 2024 (estimated)
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.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study will conduct by using a prospective randomized double-blind clinical trial model.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Toros University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Özlem ÖZPAK AKKUŞ, Toros University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06300164
- Sponsor's protocol ID
- Unripecarobinceliac
- Status last verified
- Mar 2024
- First submitted
- 19 Feb 2024
- Last updated
- 8 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data can be shared in consultation with the principal investigator.
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Unripe Carob Fruit on Oxidative Markers and Intestinal Permeability and Microbiota in Celiac Patients
- ClinicalTrials.gov ID
- NCT06300164
- Acronym / sponsor ID
- Unripecarobinceliac
- Conditions
- Celiac Disease
- Keywords
- Celiac, Unripe carob, Antioxidant, Microbiota
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Toros UniversityUniversity, hospital or other
- Study start
- 1 Apr 2024 (estimated)
- Primary completion
- 1 May 2024 (estimated)
- Study completion
- 1 Jul 2024 (estimated)
- First posted
- 8 Mar 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.
The aim of this study was to investigate the effects of the consumption of cookies produced by adding the unripe part of carob fruit, which has high insoluble fiber, polyphenol and antioxidant content, on the oxidative parameters (TAS and MDA), intestinal permeability (zonulin, GIP) and microbiota of celiac patients and to develop new products containing unripe carob fruit for celiac patients in this direction.
Detailed description
Between 01.02.2022 and 30.05.2022 by Specialist Dr. Orhan SEZGİN
The study will be conducted with 30 volunteers who present to the Mersin University Faculty of Medicine Hospital Gastroenterology Department in Mersin.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- The study will conduct by using a prospective randomized double-blind clinical trial model.
| Arm | Type | Receives |
|---|---|---|
| People with celiac disease who eat cookies with unripe carob - Experimental Group | Experimental | Dietary Supplement: Unripre CarobIndividuals with celiac disease who met the inclusion criteria and participated in the study will divided into two groups by Specialist OrhN SEZGİN, and they will be asked to consume the cookies produced (in the preliminary study) produced as a standard (n=15) and with the addition of unripe carob (n=15) for eight weeks. The individuals participating in the study will be asked not to change their eating habits, physical activity habits, and drug treatments during the study period. Each individual participating in the study will be provided with the required amount of cookie during the study and will be contacted weekly by Ecem GÜLÜŞEN, a dietitian, to verify whether they consume cookies regularly. |
| No intervention - Control Group | No intervention | –Individuals with celiac disease will not eat unripe carob cookie |
Who may qualify
- Ages
- 19 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (14 listed)
- Have been diagnosed with celiac disease within a maximum period of 1 year,
- Have not received dietary treatment by a dietitian before
- Body Mass Index value between 18.5-25.0 kg/m2,
- Who have consumed carob fruit and have not had any allergies,
- Signed the Informed Consent Form,
Key exclusion criteria (15 listed)
- Diagnosed with celiac disease for more than 1 year,
- Have gastrointestinal diseases other than celiac disease,
- Have previously received dietary treatment by a dietitian, following a diet other than a gluten-free diet,
- Body Mass Index values below 18.5 kg/m2 and above 25.0 kg/m2,
- Who have consumed carob fruit and have had any allergies,
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 |
|---|---|---|
| Unripre CarobThe standard cookies and test cookies (with carob addition) to be used in the study will be produced by Dr. Lecturer Özlem ÖZPAK AKKUŞ at Toros University Nutrition Principles Laboratory. Prof. Dr. Özlem ÖZPAK AKKUŞ will produce the cookies. For standard cookies, 1 egg, 325 g gluten-free flour (Söke flour), 75 grams butter, 50 grams sugar, 10 grams baking powder, 10 grams vanilla will be added and the prepared bread mixture will be divided into 50 equal parts. To make cookies with the addition of unripe carob, the same recipe as the standard cookie will be used to make the test cookie with the addition of unripe carob fruit flour, divided into 50 equal parts, and the amount of unripe carob fruit flour will be added by calculating the daily fiber consumption amount of the patients participating in the study to be 25 g. | Dietary supplement | People with celiac disease who eat cookies with unripe carob - Experimental Group |
Primary outcome
Examination of between group differences regarding serum Total Antioxidant Capacity (TAC)
Time frame: First day at the beginning of the study
Examination of intergroup differences of the concentration of the serum total antioxidant capacity for the determination of antioxidant capacity status in celiac diseases
Examination of between group differences regarding serum Malondialdehyde (MDA)
Time frame: First day at the beginning of the study
Examination of intergroup differences of the concentration of the serum malondialdehyde for the determination of oxidant capacity status in celiac diseases
Examination of between group differences regarding serum zonulin
Time frame: First day at the beginning of the study
Examination of intergroup differences of the concentration of the serum zonulin for the determination of intestinal permeability in celiac diseases
3 secondary outcomes
Comparison of between group differences regarding serum Total Antioxidant Capacity (TAC)
Time frame: Eight weeks after the start of the study
Comparison of between group differences regarding serum Malondialdehyde (MDA)
Time frame: Eight weeks after the start of the study
Comparison of between group differences regarding serum zonulin
Time frame: Eight weeks after the start of the study
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2024.
- Individual participant dataSharing planned: Yes. Data can be shared in consultation with the principal investigator.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Unripre Carob in people with Celiac Disease, run by Toros University.
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 14 inclusion and 15 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: status not confirmed, as of the sponsor's last update on 8 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
Examination of between group differences regarding serum Total Antioxidant Capacity (TAC) (time frame: First day at the beginning of the study). The study lists 3 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 8 Mar 2024.