The Effect of Unripe Carob Fruit in Celiac Patients

NCT ID: NCT06300164

Last Updated: 2024-03-08

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-01
• Study Completion Date: 2024-07-01

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.

Conditions

Celiac Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Unripre Carob

Intervention Type: DIETARY_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.

No intervention - Control Group

Individuals with celiac disease will not eat unripe carob cookie

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: DIETARY_SUPPLEMENT

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)

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Toros University

OTHER

Sponsor Role: lead

Responsible Party

Özlem ÖZPAK AKKUŞ

Asst.Prof.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

Unripecarobinceliac

Identifier Type: -

Identifier Source: org_study_id