A Taste and Acceptance Study of FruitiVits, for Use in the Dietary Management of Young Children Requiring Very Restrictive Diets Such as the Ketogenic Diet.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 11
- 试验地点
- 2
- 主要终点
- Acceptability of FruitiVits
研究概览
简要总结
Subjects will be asked to substitute their usual vitamin and mineral supplement/s with FruitiVits for seven consecutive days.
详细描述
The study will involve 12 subjects between 4 and 8 years of age, who routinely use comprehensive micronutrient supplementation as part of their dietary management.
Primary Hypothesis:
FruitiVits is an acceptable source of vitamin, mineral and trace elements for patients on a Ketogenic diet.
Secondary Hypothesis:
FruitiVits will be well accepted and tolerated when given orally to children on a Ketogenic diet.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 4 Years 至 9 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of condition requiring a Ketogenic diet
- •Currently on a Ketogenic diet
- •Aged 4 - 8 years
- •Routinely taking a complete micronutrient supplement
- •Oral feeding
排除标准
- •Children aged less than 4 years or older than 9 years of age
研究组 & 干预措施
FruitiVits
Daily administration of FruitiVits dietary supplement
干预措施: FruitiVits (Dietary Supplement)
结局指标
主要结局
Acceptability of FruitiVits
时间窗: Day 8 of trial
The study product was rated on a scale of 1-5: 1. (liked very much) 2. (liked moderately) 3. (neither liked nor disliked) 4. (disliked moderately) 5. (disliked very much).
次要结局
- Ease of Preparation of FruitiVits(Day 8 of trial)