NCT01782456已完成不适用
Tolerance of an Oral Nutritional Supplement(ONS)With a New Protein Blend in Healthy Children
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Gastro-Intestinal Tolerance
研究概览
简要总结
The objective of this study is to capture information on gastrointestinal tolerance (GI) of an oral nutritional supplement containing a new protein blend in healthy children aged ≥ 3 to ≤ 10 years.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 盲法
- None
入排标准
- 年龄范围
- 3 Years 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age ≥ 3 and ≤ 10 years of age
- •Healthy and not suffering from any physical disability.
- •Height-for-age and BMI-for-age between the 5th and the 95th percentile as well as a weight-for-age between the 5th and the 85th percentile
- •Consumption of 2 servings/day of the investigational product for 7 consecutive days
- •Willingness to follow the study procedures and record the data in the diary and complete any forms or assessment as needed throughout the study
- •Agreement to not consume a nutritional product that is not study product during the study period
排除标准
- •History of an acute or chronic condition that may affect feeding habits or nutritional status
- •Medications or nutritional supplements, taken on a daily basis for more than 2 weeks during the past month prior to screening visit that may profoundly affect feeding habits or nutritional status
- •Clinically significant nutritional deficiency requiring specific treatment
- •Acute/chronic condition requiring medical treatment which may include hospitalization such as diabetes or stress induced hyperglycemia, dialysis treatment, inflammatory bowel disease, pancreatitis, autoimmune disease or immunodeficiency, celiac disease, cystic fibrosis, active tuberculosis, malformation of the gastrointestinal tract or gastroesophageal reflux disease
- •History of constipation
- •Allergy or intolerance to any ingredient in the study product
- •Gastrointestinal infection or acute diarrhea at the time of study start
- •Hepatitis B or C, or HIV, or malignancy
- •Congenital cardiac defects
- •Antibiotic therapy within last 2 weeks of start of study
- •Dysphagia, aspiration risk, difficulty in swallowing due to acquired/congenital abnormalities
结局指标
主要结局
Gastro-Intestinal Tolerance
时间窗: Study Day 1-7
Self-reported Questionnaire
次要结局
- Study Supplement Compliance(Study Day 1-7)
- Weight(Study Day 1 and 8)
- Height(Study Day 1 and 8)
研究者
研究点 (2)
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