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The Effect of Unripe Carob Fruit in Celiac Patients

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 19 Years - 64 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - 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, - 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)

Exclusion Criteria:

- 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, - 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)

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT06300164
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Toros University
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other
Overall Status Not yet recruiting
Countries
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Celiac Disease
Additional Details

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.

Arms & Interventions

Arms

Experimental: People with celiac disease who eat cookies with unripe carob - Experimental Group

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.

No Intervention: No intervention - Control Group

Individuals with celiac disease will not eat unripe carob cookie

Interventions

Dietary Supplement: - Unripre Carob

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.

Contact Information

This trial has no sites locations listed at this time. If you are interested in learning more, you can contact the trial's primary contact:

For additional contact information, you can also visit the trial on clinicaltrials.gov.

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