NCT02156986已完成不适用
Effect of Food Structural Properties on Infants and Toddlers Mastication Abilities
Société des Produits Nestlé (SPN)1 个研究点 分布在 1 个国家目标入组 68 人开始时间: 2013年10月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 68
- 试验地点
- 1
- 主要终点
- Muscle activities involved in the mastication using Electromyography (EMG)
研究概览
简要总结
The main objective of the study is to conduct a pilot study on the characterization of the mastication abilities of infants and toddlers using different commercial cereal based products in order to gain knowledge and be able to plan future studies.
研究设计
- 研究类型
- Observational
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 9 Months 至 36 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Born at term (37+ weeks)
- •Familiar with solid foods
- •No known history of food allergies
- •Child must be within 2 weeks of the targeted age group for 9 months, within 1 month for 12 months, within 2 months for 18 and 24 months, and within 3 months for 36 months for this study.
- •English must be the primary language of the participant and family.
- •Having obtained his/her caregiver's or legal representative's informed consent.
排除标准
- •History of speech/language, cognitive, or physical impairments as indicated on the self-reported medical history questionnaire completed by caregiver or legal guardian
- •Any previously undiagnosed speech/language or cognitive impairment detected by the Investigator. In the case a subject is identified as being at risk for a communication or feeding impairment, the caregiver will be notified and provided with a list of local speech-language pathology providers who could perform a formal assessment
- •History of poor weight gain/ weight loss, food allergies, difficulties with sucking, difficulties with chewing and/ or swallowing, frequent drooling (for age groups 18, 24, and 36 months), frequent choking, gastro-esophageal reflux, frequent spitting up/ vomiting (for age groups 18, 24, and 36 months) or irritability after feedings/ eating
- •Latex allergies
- •Currently participating in or having participated in a similar clinical trial related to food/diet within the last 9 months
- •Caregiver must not be under the age of 18 years old.
结局指标
主要结局
Muscle activities involved in the mastication using Electromyography (EMG)
时间窗: One day during the study visit 2
次要结局
未报告次要终点
研究者
研究点 (1)
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