Development and Efficacy Assessment of Aglutenic Product to Improve the Nutritional Status of Celiac Children
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 75
- 试验地点
- 2
- 主要终点
- Total Protein
研究概览
简要总结
Randomized controlled trial will be conducted after getting informed consent form from each study participant meeting inclusion criteria (n=70, 35 control group +35 intervention group, 3-8years of age). After consumer acceptance against various attributes of aglutenic cupcake, the product will be provided in polyethylene bags containing 28 cupcakes (35gm by weight/cupcake, 2 cupcakes for each day) providing approximately 20% daily value (DV) of energy. Cupcakes of equal weight and size made with rice flour (mostly used recipe) will be provided to the control group. Further product will be provided on follow-up visits. The compliance to a gluten free diet GFD and supplemented product will be confirmed by a Food Frequency Questionnaire (FFQ).
详细描述
Raw Material/ Preparation of flour blends for aglutenic (gluten free) cupcakes:
Sorghum, chickpea, Flaxseed and Almond rich in healthy nutrients will be purchased from the local market. All these ingredients was ground into fine powder using uncontaminated grinder. Different flour blends was prepared by substituting whole wheat flour with Sorghum, Chickpea, Flaxseed and Almond flour at different replacement levels.
The efficacy study protocol was approved by the Bioethics Committee for randomized controlled trial (RCT). Written informed consent was obtained by the parents of children or their legal guardian.
Target population: Celiac Disease/gluten sensitive patients (n= 70, 35 control + 35 intervention) was recruited according to European Society for Pediatric Gastroenterology Hepatology and Nutrition (ESPGHAN) criteria.
Inclusion criteria:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 3 Years 至 8 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Positive tissue trans-glutaminase antibody (tTG)
- •Clinical response to gluten free diet
排除标准
- •Vitamins and mineral supplements
- •Intestinal inflammatory diseases
- •Malignant diseases of intestines
- •Chronic infections,
- •Thyroid, renal or hepatic alterations
- •Celiac patients with diabetes
- •Taking drugs known to effect lipid and /or carbohydrate metabolism
结局指标
主要结局
Total Protein
时间窗: 12 weeks
Serum Total Protein g/dL
Mid upper Arm Circumference (MUAC)
时间窗: 12 weeks
Mid-upper arm circumference (MUAC) in centimeters will be measured midpoint between the acromion process of the scapula and the tip of the elbow.
Serum Electrolytes
时间窗: 12 weeks
Sodium mmol/L Calcium mg/dL Potassium mmol/L
Body Weight
时间窗: 12 weeks
Body weight (in kilograms) will be measured using a weight machine with standardization done after every 20 readings.
Height of the patients
时间窗: 12 weeks
Height (in centimeters) will be measured (without shoes) in the position, back and hips touching the wall by using wall mounted stedio-meter
Body Mass Index (BMI)
时间窗: 12 weeks
BMI will be calculated by using standard formula as weight in kilograms divided by height in meter square kg/m2. World Health Organization (WHO) standard growth charts, designed separately for boys and girls will be used as a research tool to assess the nutritional status.
Complete Blood Count (CBC)
时间窗: 12 weeks
White Blood Cells 10\^9/L Red Blood Cells million/mm3 Mean Corpuscular Volume 10\^6/µL Hemoglobin g/dL Hematocrit % Platelets 10\^9/L
Lipid Profile
时间窗: 12 weeks
High Density Lipoproteins mg/dL Low Density Lipoproteins mg/dL Very Low-Density Lipoproteins mg/dL Serum Total Cholesterol mg/dL
Liver Enzymes
时间窗: 12 weeks
serum glutamic-pyruvic transaminase SGPT- U/L, serum glutamic-oxaloacetic transaminase SGOT-U/L
次要结局
- Gastrointestinal Symptoms(12 weeks)
研究者
Shaista Jabeen
Principal Investigator
University of Veterinary and Animal Sciences, Lahore - Pakistan