The Effect of Unripe Carob Fruit in Celiac Patients

NCT06300164 | Not Yet Recruiting DMC

• 1 other identifier: Unripecarobinceliac
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Celiac Disease

Keywords

Celiac; Unripe carob; Antioxidant; Microbiota

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• Comparison of between group differences regarding serum Total Antioxidant Capacity (TAC)

  Eight weeks after the start of the study

• Comparison of between group differences regarding serum Malondialdehyde (MDA)

  Eight weeks after the start of the study

• Comparison of between group differences regarding serum zonulin

  Eight weeks after the start of the study

Study Arms (2)

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

EXPERIMENTAL

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

No intervention - Control Group

NO INTERVENTION

Individuals with celiac disease will not eat unripe carob cookie

Interventions

Unripre Carob 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.

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

Eligibility Criteria

• Age: 19 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Toros University: lead

MeSH Terms

Conditions

Celiac Disease

Condition Hierarchy (Ancestors)

Malabsorption Syndromes; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: Participants will not know which type of cookies to eat.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Asst.Prof.

Model Details: The study will conduct by using a prospective randomized double-blind clinical trial model.

Study Record Dates

• First Submitted: February 19, 2024
• First Posted: March 8, 2024
• Study Start: April 1, 2024
• Primary Completion: May 1, 2024
• Study Completion: July 1, 2024
• Last Updated: March 8, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will share
• Time Frame: Data can be shared after the research is published in consultation with the principal investigator.
• Access Criteria: Data can be shared after the research is published in consultation with the principal investigator.