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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.
Between 01.02.2022 and 30.05.2022 by Specialist Dr. Orhan SEZGÄ°N
The study will be conducted with 30 volunteers who present to the Mersin University Faculty of Medicine Hospital Gastroenterology Department in Mersin.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| No intervention - Control Group | No Intervention | Individuals with celiac disease will not eat unripe carob cookie |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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Data can be shared in consultation with the principal investigator.
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Data can be shared after the research is published in consultation with the principal investigator.
Data can be shared after the research is published in consultation with the principal investigator.
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| ID | Term |
|---|---|
| D002446 | Celiac Disease |
| ID | Term |
|---|---|
| D008286 | Malabsorption Syndromes |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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The study will conduct by using a prospective randomized double-blind clinical trial model.
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Participants will not know which type of cookies to eat.
|
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 |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |