The Effect of Unripe Carob Fruit on Oxidative Markers and Intestinal Permeability and Microbiota in Celiac Patients
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Toros University
- Enrollment
- 30
- Primary Endpoint
- Examination of between group differences regarding serum Malondialdehyde (MDA)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Double (Participant, Care Provider)
Masking Description
Participants will not know which type of cookies to eat.
Eligibility Criteria
- Ages
- 19 Years to 64 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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)
Arms & Interventions
No intervention - Control Group
Individuals with celiac disease will not eat unripe carob cookie
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.
Intervention: Unripre Carob (Dietary Supplement)
Outcomes
Primary Outcomes
Examination of between group differences regarding serum Malondialdehyde (MDA)
Time Frame: First day at the beginning of the study
Examination of intergroup differences of the concentration of the serum malondialdehyde for the determination of oxidant capacity status in celiac diseases
Examination of between group differences regarding serum Total Antioxidant Capacity (TAC)
Time Frame: First day at the beginning of the study
Examination of intergroup differences of the concentration of the serum total antioxidant capacity for the determination of antioxidant capacity status in celiac diseases
Examination of between group differences regarding serum zonulin
Time Frame: First day at the beginning of the study
Examination of intergroup differences of the concentration of the serum zonulin for the determination of intestinal permeability in celiac diseases
Secondary Outcomes
- Comparison of between group differences regarding serum zonulin(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 Total Antioxidant Capacity (TAC)(Eight weeks after the start of the study)
Investigators
Özlem ÖZPAK AKKUŞ
Asst.Prof.
Toros University