NCT02781298已完成不适用
Acceptability, Tolerance, Satiety and Prebiotic Effect of a New Infant Cereal in Infant Between 5 and 8 Months of Age, at the Beginning of Complementary Feeding
Hero Institute for Infant Nutrition8 个研究点 分布在 1 个国家目标入组 46 人开始时间: 2014年12月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 46
- 试验地点
- 8
- 主要终点
- Hedonic scale- Sensorial Evaluation
研究概览
简要总结
This study evaluates a new infant cereals on acceptability, tolerance, satiety and prebiotic effect in infants.
详细描述
This is a controlled, randomized, prospective, crossover, triple-blind study to evaluate of a new infant cereal with a portion of whole grain flour on sensorial acceptability, gastrointestinal tolerance, satiety and prebiotic effect in healthy infants fron 5 to 8 months of age at the beginning of complementary feeding.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 5 Months 至 6 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy term infant
- •Birth weight 2500-4200 g
- •Tolerance to cow's milk
- •Tolerance to lactose
- •No Breastfeeding at least 4 months of age
- •No use antibiotic at least 2 weeks before recruitments
排除标准
- •Intolerance to gluten (celiac disease)
- •Congenital abnormalities
- •Acute diseases
- •Chronic situation that affect to food intake or metabolism
- •Breastfeeding infant
- •Any food allergy
- •Participation in other study
结局指标
主要结局
Hedonic scale- Sensorial Evaluation
时间窗: Day 24, day 73
Sensorial acceptability -Differences between groups measured by Hedonic scales (4-points for children and 7-points for adults)
次要结局
- Head Circumference(Day 1 (Baseline), Day 45, day 93.)
- Gastrointestinal tolerance(Day 7, day 24, day 45, day 52, day 73, day 93)
- Intestinal habits(Day 7, day 24, day 45, day 52, day 73, day 93)
- Satiety(Day 7, day 24, day 45, day 52, day 73, day 93)
- Weight(Day 1 (Baseline), Day 45, day 93.)
- Length(Day 1 (Baseline), Day 45, day 93.)
- Prebiotic effects(Day 1 (baseline), day 45)
研究者
Luis Manuel Sanchez Siles
Director Innovation Infant Nutrition
Hero Institute for Infant Nutrition
研究点 (8)
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