A2 β-casein-containing Milk and Dairy Products, Celiac Disease, Celiac Disease in Children
Conditions
Brief summary
The goal of this clinical trial is to evaluate the effect of A2 β-casein-containing milk and dairy product consumption on nutritional status, gastrointestinal symptoms, quality of life, sleep quality, and selected biochemical parameters in adolescents aged 10-18 years with celiac disease. The main questions it aims to answer are: * Does consumption of A2 β-casein-containing milk and dairy products improve gastrointestinal symptoms and quality of life in adolescents with celiac disease? * Does consumption of A2 β-casein-containing milk and dairy products affect nutritional status, body composition, and biochemical parameters compared with standard milk and dairy products? Researchers will compare adolescents consuming A2 β-casein-containing milk and dairy products with adolescents consuming standard milk and dairy products to see if A2 β-casein provides additional benefits. Participants will: * Consume the assigned milk and dairy products during the intervention period. * Attend baseline and follow-up assessments. * Complete dietary records and questionnaires related to gastrointestinal symptoms, sleep quality, and quality of life. * Undergo anthropometric, body composition, hand grip strength, and biochemical assessments.
Interventions
DIETARY_SUPPLEMENTA2 β-casein milk and dairy products
Participants consumed milk and dairy products containing A2 β-casein during the 8-week intervention period.
DIETARY_SUPPLEMENTStandard milk and dairy products
Participants consumed standard milk and dairy products during the 8-week intervention period.
Sponsors
Halic University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
10 Years to 18 Years
Healthy volunteers
Yes
Inclusion criteria
* Adolescents aged 10-18 years * Diagnosis of celiac disease according to ESPGHAN criteria * Being diagnosed with celiac disease within the last 3 months * Volunteering to participate in the study
Exclusion criteria
* Presence of any chronic disease other than celiac disease * Presence of lactose intolerance * Presence of cow's milk protein allergy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Celiac Disease-Specific Quality of Life Total Score at Week 8 | Baseline and Week 8 | Celiac disease-specific quality of life will be assessed using the Celiac Disease Dutch Questionnaire (CDDUX). The total score ranges from 0 to 100, with higher scores indicating better quality of life. |
| Change From Baseline in Celiac Symptom Index Total Score at Week 8 | Baseline and 8 weeks | Gastrointestinal symptoms will be assessed using the Celiac Symptom Index (CSI). The CSI total score ranges from 16 to 80, with higher scores indicating more severe celiac disease-related symptoms. |
| Change From Baseline in Anti-tTG IgA Level at Week 8 | Baseline and Week 8 | Serum anti-tissue transglutaminase immunoglobulin A (anti-tTG IgA) level will be measured and reported as RU/mL to assess the change from baseline to Week 8. |
| Change From Baseline in Anti-tTG IgG Level at Week 8 | Baseline and Week 8 | Serum anti-tissue transglutaminase immunoglobulin G (anti-tTG IgG) level will be measured and reported as RU/mL to assess the change from baseline to Week 8. |
| Change From Baseline in Leukocyte Count at Week 8 | Baseline and Week 8 | Leukocyte count will be measured in blood samples and reported as 10⁹/L to assess the change from baseline to Week 8. |
| Change From Baseline in Neutrophil Count at Week 8 | Baseline and Week 8 | Absolute neutrophil count will be measured in blood samples and reported as 10⁹/L to assess the change from baseline to Week 8. |
| Change From Baseline in Neutrophil-to-Lymphocyte Ratio at Week 8 | Baseline and Week 8 | The neutrophil-to-lymphocyte ratio (NLR) will be calculated by dividing the absolute neutrophil count by the absolute lymphocyte count. NLR will be reported as a unitless ratio to assess the change from baseline to Week 8. |
| Change From Baseline in Serum Albumin Level at Week 8 | Baseline and Week 8 | Serum albumin level will be measured and reported as g/L to assess the change from baseline to Week 8. |
| Change From Baseline in Serum Total Protein Level at Week 8 | Baseline and Week 8 | Serum total protein level will be measured and reported as g/L to assess the change from baseline to Week 8. |
| Change From Baseline in Serum Alanine Aminotransferase Level at Week 8 | Baseline and Week 8 | Serum alanine aminotransferase (ALT) level will be measured and reported as U/L to assess the change from baseline to Week 8. |
| Change From Baseline in Serum Aspartate Aminotransferase Level at Week 8 | Baseline and Week 8 | Serum aspartate aminotransferase (AST) level will be measured and reported as U/L to assess the change from baseline to Week 8. |
| Change From Baseline in Serum Ferritin Level at Week 8 | Baseline and Week 8 | Serum ferritin level will be measured and reported as µg/L to assess the change from baseline to Week 8. |
| Change From Baseline in Serum Folate Level at Week 8 | Baseline and Week 8 | Serum folate level will be measured and reported as µg/L to assess the change from baseline to Week 8. |
| Change From Baseline in Serum Vitamin B12 Level at Week 8 | Baseline and Week 8 | Serum vitamin B12 level will be measured and reported as ng/L to assess the change from baseline to Week 8. |
| Change From Baseline in Serum Calcium Level at Week 8 | Baseline and Week 8 | Serum calcium level will be measured and reported as mg/dL to assess the change from baseline to Week 8. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Body Weight at Week 8 | Baseline and Week 8 | Body weight will be measured and reported in kilograms (kg) to assess the change from baseline to Week 8. |
| Change From Baseline in Height at Week 8 | Baseline and Week 8 | Height will be measured and reported in centimeters (cm) to assess the change from baseline to Week 8. |
| Change From Baseline in Body Mass Index at Week 8 | Baseline and Week 8 | Body mass index (BMI) will be calculated by dividing body weight in kilograms by height in meters squared and reported as kg/m² to assess the change from baseline to Week 8. |
| Change From Baseline in BMI-for-Age Z Score at Week 8 | Baseline and Week 8 | BMI-for-age Z score will be calculated using the World Health Organization 2007 growth reference for children and adolescents aged 5-19 years to assess the change from baseline to Week 8. A score of 0 represents the median of the reference population. |
| Change From Baseline in Height-for-Age Z Score at Week 8 | Baseline and Week 8 | Height-for-age Z score will be calculated using the World Health Organization 2007 growth reference for children and adolescents aged 5-19 years to assess the change from baseline to Week 8. A score of 0 represents the median of the reference population. |
| Change From Baseline in Mid-Upper Arm Circumference at Week 8 | Baseline and Week 8 | Mid-upper arm circumference (MUAC) will be measured and reported in centimeters (cm) to assess the change from baseline to Week 8. |
| Change in Sleep Quality Assessed by the Pittsburgh Sleep Quality Index (PSQI) | Baseline and Week 8 | Sleep quality will be assessed using the Pittsburgh Sleep Quality Index (PSQI). The PSQI total score ranges from 0 to 21, with higher scores indicating poorer sleep quality. |
| Change in Hand Grip Strength Measured Using a TAKEI TKK-5401 Hand Dynamometer | Baseline and Week 8 | Hand grip strength (kg) will be measured using a TAKEI TKK-5401 hand dynamometer. |
| Change in Stool Form Assessed by the Bristol Stool Form Scale (BSFS) | Baseline and Week 8 | Stool form will be assessed using the Bristol Stool Form Scale (BSFS). The scale classifies stool form into seven types (Types 1-7), with Types 1-2 indicating constipation, Types 3-4 indicating normal stool form, and Types 5-7 indicating loose stools or diarrhea. |
| Change From Baseline in Trunk Fat Percentage at Week 8 | Baseline and Week 8 | Trunk fat percentage will be assessed using bioelectrical impedance analysis (Tanita BC-601) and reported as a percentage (%) to assess the change from baseline to Week 8. |
| Change From Baseline in Total Body Fat Percentage at Week 8 | Baseline and Week 8 | Total body fat percentage will be assessed using bioelectrical impedance analysis (Tanita BC-601) and reported as a percentage (%) to assess the change from baseline to Week 8. |
| Change From Baseline in Right Arm Fat Percentage at Week 8 | Baseline and Week 8 | Right arm fat percentage will be assessed using bioelectrical impedance analysis (Tanita BC-601) and reported as a percentage (%) to assess the change from baseline to Week 8. |
| Change From Baseline in Left Arm Fat Percentage at Week 8 | Baseline and Week 8 | Left arm fat percentage will be assessed using bioelectrical impedance analysis (Tanita BC-601) and reported as a percentage (%) to assess the change from baseline to Week 8. |
| Change From Baseline in Right Leg Fat Percentage at Week 8 | Baseline and Week 8 | Right leg fat percentage will be assessed using bioelectrical impedance analysis (Tanita BC-601) and reported as a percentage (%) to assess the change from baseline to Week 8. |
| Change From Baseline in Left Leg Fat Percentage at Week 8 | Baseline and Week 8 | Left leg fat percentage will be assessed using bioelectrical impedance analysis (Tanita BC-601) and reported as a percentage (%) to assess the change from baseline to Week 8. |
| Change From Baseline in Body Fat Mass at Week 8 | Baseline and Week 8 | Body fat mass will be assessed using bioelectrical impedance analysis (Tanita BC-601) and reported in grams (g) to assess the change from baseline to Week 8. |
| Change From Baseline in Fat-Free Mass at Week 8 | Baseline and Week 8 | Fat-free mass will be assessed using bioelectrical impedance analysis (Tanita BC-601) and reported in grams (g) to assess the change from baseline to Week 8. |
Countries
Turkey (Türkiye)
Outcome results
None listed