Clinical trial NCT06300164: The Effect of Unripe Carob Fruit in Celiac Patients
Official title: The Effect of Unripe Carob Fruit on Oxidative Markers and Intestinal Permeability and Microbiota in Celiac Patients
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Celiac Disease
Keywords: Celiac
Unripe carob
Antioxidant
Microbiota
Lead sponsor: Toros University
Sponsor class: OTHER
First posted: 2024-03-08
Enrollment: 30
Sex: ALL
Minimum age (years): 19
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study will conduct by using a prospective randomized double-blind clinical trial model.
Primary purpose: SUPPORTIVE_CARE

Brief 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 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.

Eligibility 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)

Primary outcomes:
measure: Examination of between group differences regarding serum Total Antioxidant Capacity (TAC)
timeFrame: First day at the beginning of the study
measure: Examination of between group differences regarding serum Malondialdehyde (MDA)
timeFrame: First day at the beginning of the study
measure: Examination of between group differences regarding serum zonulin
timeFrame: First day at the beginning of the study
Secondary outcomes:
measure: Comparison of between group differences regarding serum Total Antioxidant Capacity (TAC)
timeFrame: Eight weeks after the start of the study
measure: Comparison of between group differences regarding serum Malondialdehyde (MDA)
timeFrame: Eight weeks after the start of the study
measure: Comparison of between group differences regarding serum zonulin
timeFrame: Eight weeks after the start of the study
Other outcomes:
Locations:
Study officials:
References: