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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Change From Baseline in Celiac Disease-Specific Quality of Life Total Score at Week 8
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 10 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •Presence of any chronic disease other than celiac disease
- •Presence of lactose intolerance
- •Presence of cow's milk protein allergy
研究组 & 干预措施
A2 β-casein-containing milk and dairy products
Participants assigned to this group consumed milk and dairy products containing A2 β-casein during the intervention period.
干预措施: A2 β-casein milk and dairy products (Dietary Supplement)
Standard milk and dairy products group
Participants assigned to this group consumed standard milk and dairy products containing conventional β-casein during the intervention period.
干预措施: Standard milk and dairy products (Dietary Supplement)
结局指标
主要结局
Change From Baseline in Celiac Disease-Specific Quality of Life Total Score at Week 8
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: Baseline and Week 8
Serum calcium level will be measured and reported as mg/dL to assess the change from baseline to Week 8.
次要结局
- Change From Baseline in Body Weight at Week 8(Baseline and Week 8)
- Change From Baseline in Height at Week 8(Baseline and Week 8)
- Change From Baseline in Body Mass Index at Week 8(Baseline and Week 8)
- Change From Baseline in BMI-for-Age Z Score at Week 8(Baseline and Week 8)
- Change From Baseline in Height-for-Age Z Score at Week 8(Baseline and Week 8)
- Change From Baseline in Mid-Upper Arm Circumference at Week 8(Baseline and Week 8)
- Change in Sleep Quality Assessed by the Pittsburgh Sleep Quality Index (PSQI)(Baseline and Week 8)
- Change in Hand Grip Strength Measured Using a TAKEI TKK-5401 Hand Dynamometer(Baseline and Week 8)
- Change in Stool Form Assessed by the Bristol Stool Form Scale (BSFS)(Baseline and Week 8)
- Change From Baseline in Trunk Fat Percentage at Week 8(Baseline and Week 8)
- Change From Baseline in Total Body Fat Percentage at Week 8(Baseline and Week 8)
- Change From Baseline in Right Arm Fat Percentage at Week 8(Baseline and Week 8)
- Change From Baseline in Left Arm Fat Percentage at Week 8(Baseline and Week 8)
- Change From Baseline in Right Leg Fat Percentage at Week 8(Baseline and Week 8)
- Change From Baseline in Left Leg Fat Percentage at Week 8(Baseline and Week 8)
- Change From Baseline in Body Fat Mass at Week 8(Baseline and Week 8)
- Change From Baseline in Fat-Free Mass at Week 8(Baseline and Week 8)