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Completed

NCT Number: NCT07815821

Effects of A2 Dairy Consumption in Celiac Adolescents

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.

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Key information

Conditions

Celiac Disease A2 β-casein-containing Milk and Dairy Products Celiac Disease in Children Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases Malabsorption Syndromes Metabolic Diseases Nutritional and Metabolic Diseases

Age range

10 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sariyer Hamidiye Etfal Training and Research Hospital

Istanbul, 34421, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

A2 β-casein milk and dairy products

Dietary Supplement

Participants consumed milk and dairy products containing A2 β-casein during the 8-week intervention period.

Standard milk and dairy products

Dietary Supplement

Participants consumed standard milk and dairy products during the 8-week intervention period.

Primary outcomes

  1. Change From Baseline in Celiac Disease-Specific Quality of Life Total Score at Week 8

    Time frame: 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.

  2. Change From Baseline in Celiac Symptom Index Total Score at Week 8

    Time frame: 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.

  3. Change From Baseline in Anti-tTG IgA Level at Week 8

    Time frame: 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.

  4. Change From Baseline in Anti-tTG IgG Level at Week 8

    Time frame: 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.

  5. Change From Baseline in Leukocyte Count at Week 8

    Time frame: 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.

  6. Change From Baseline in Neutrophil Count at Week 8

    Time frame: 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.

  7. Change From Baseline in Neutrophil-to-Lymphocyte Ratio at Week 8

    Time frame: 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.

  8. Change From Baseline in Serum Albumin Level at Week 8

    Time frame: Baseline and Week 8

    Serum albumin level will be measured and reported as g/L to assess the change from baseline to Week 8.

  9. Change From Baseline in Serum Total Protein Level at Week 8

    Time frame: 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.

  10. Change From Baseline in Serum Alanine Aminotransferase Level at Week 8

    Time frame: 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.

  11. Change From Baseline in Serum Aspartate Aminotransferase Level at Week 8

    Time frame: 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.

  12. Change From Baseline in Serum Ferritin Level at Week 8

    Time frame: Baseline and Week 8

    Serum ferritin level will be measured and reported as µg/L to assess the change from baseline to Week 8.

  13. Change From Baseline in Serum Folate Level at Week 8

    Time frame: Baseline and Week 8

    Serum folate level will be measured and reported as µg/L to assess the change from baseline to Week 8.

  14. Change From Baseline in Serum Vitamin B12 Level at Week 8

    Time frame: 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.

  15. Change From Baseline in Serum Calcium Level at Week 8

    Time frame: 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 outcomes

  1. Change From Baseline in Body Weight at Week 8

    Time frame: Baseline and Week 8

    Body weight will be measured and reported in kilograms (kg) to assess the change from baseline to Week 8.

  2. Change From Baseline in Height at Week 8

    Time frame: Baseline and Week 8

    Height will be measured and reported in centimeters (cm) to assess the change from baseline to Week 8.

  3. Change From Baseline in Body Mass Index at Week 8

    Time frame: 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.

  4. Change From Baseline in BMI-for-Age Z Score at Week 8

    Time frame: 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.

  5. Change From Baseline in Height-for-Age Z Score at Week 8

    Time frame: 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.

  6. Change From Baseline in Mid-Upper Arm Circumference at Week 8

    Time frame: 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.

  7. Change in Sleep Quality Assessed by the Pittsburgh Sleep Quality Index (PSQI)

    Time frame: 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.

  8. Change in Hand Grip Strength Measured Using a TAKEI TKK-5401 Hand Dynamometer

    Time frame: Baseline and Week 8

    Hand grip strength (kg) will be measured using a TAKEI TKK-5401 hand dynamometer.

  9. Change in Stool Form Assessed by the Bristol Stool Form Scale (BSFS)

    Time frame: 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.

  10. Change From Baseline in Trunk Fat Percentage at Week 8

    Time frame: 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.

  11. Change From Baseline in Total Body Fat Percentage at Week 8

    Time frame: 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.

  12. Change From Baseline in Right Arm Fat Percentage at Week 8

    Time frame: 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.

  13. Change From Baseline in Left Arm Fat Percentage at Week 8

    Time frame: 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.

  14. Change From Baseline in Right Leg Fat Percentage at Week 8

    Time frame: 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.

  15. Change From Baseline in Left Leg Fat Percentage at Week 8

    Time frame: 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.

  16. Change From Baseline in Body Fat Mass at Week 8

    Time frame: 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.

  17. Change From Baseline in Fat-Free Mass at Week 8

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Halic University

Other

Registry information

Official study title

Evaluation of the Effects of Consumption of Milk and Dairy Products Containing A2 β-Casein on Nutritional Status, Quality of Life, and Certain Blood Parameters in Adolescents With Celiac Disease

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Sep 11, 2026
Registry last updated
Sep 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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