The Effect of Unripe Carob Fruit in Celiac Patients

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Celiac Disease
• Intervention / Treatment: Dietary supplement: Unripre Carob

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 Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	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.
No Intervention: No intervention - Control Group; Individuals with celiac disease will not eat unripe carob cookie

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: Toros University

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2024
• Primary Completion (Estimated): May 1, 2024
• Study Completion (Estimated): July 1, 2024

Study Registration Dates

• First Submitted: February 19, 2024
• First Submitted That Met QC Criteria: March 7, 2024
• First Posted (Actual): March 8, 2024

Study Record Updates

• Last Update Posted (Actual): March 8, 2024
• Last Update Submitted That Met QC Criteria: March 7, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Microbiota; Antioxidant; Celiac; Unripe carob
• Additional Relevant MeSH Terms: Digestive System Diseases; Metabolic Diseases; Gastrointestinal Diseases; Intestinal Diseases; Malabsorption Syndromes; Celiac Disease
• Other Study ID Numbers: Unripecarobinceliac

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data can be shared in consultation with the principal investigator.
• IPD Sharing Time Frame: Data can be shared after the research is published in consultation with the principal investigator.
• IPD Sharing Access Criteria: Data can be shared after the research is published in consultation with the principal investigator.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No