The Effect of Unripe Carob Fruit in Celiac Patients

Celiac Disease Clinical Trial

Official title:

The Effect of Unripe Carob Fruit on Oxidative Markers and Intestinal Permeability and Microbiota in Celiac Patients

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06300164
• Other study ID #: Unripecarobinceliac
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 1, 2024
• Est. completion date: July 1, 2024

Study information

• Verified date: March 2024
• Source: Toros University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 and to develop new products containing unripe carob fruit for celiac patients in this direction.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: July 1, 2024
• Est. primary completion date: May 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 64 Years

Eligibility

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)

Related Conditions & MeSH terms

• Celiac Disease

Intervention

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 AKKUS at Toros University Nutrition Principles Laboratory. Prof. Dr. Özlem ÖZPAK AKKUS 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Toros University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	First day at the beginning of the study
Primary	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	First day at the beginning of the study
Primary	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	First day at the beginning of the study
Secondary	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	Eight weeks after the start of the study
Secondary	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	Eight weeks after the start of the study
Secondary	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	Eight weeks after the start of the study