A Study to Evaluate the Acceptability of ZestiVits; a New Vitamin, Mineral and Trace Element Supplement for Those Aged 11 and Over on a Ketogenic or Restricted Diet With Regard to Product Tolerance, Palatability and Compliance
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 6
- 主要终点
- Palatability via qualitative assessments from a subject questionnaire
研究概览
简要总结
A study to evaluate the acceptability of ZestiVits; a new vitamin, mineral and trace element supplement for children aged 11 years and over and adults on a ketogenic or restricted therapeutic diet with regard to product tolerance, palatability and compliance.
详细描述
To evaluate the gastrointestinal tolerance, palatability and compliance of ZestiVits in a seven-day period for 15 subjects aged 11 years and over following a ketogenic or restricted therapeutic diet.
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Qualitative assessments from subject questionnaires that allow evaluation of the acceptability and ease of use of the study product.
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Collection of daily data about the gastro-intestinal tolerance of the study product.
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Collection of daily data about compliance with the study product i.e. actual versus prescribed intake.
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Improve quality of life by increasing range of products available for use in a ketogenic or restricted therapeutic 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
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 11 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of condition requiring a ketogenic or restrictive therapeutic diet
- •On a ketogenic or restricted therapeutic diet with good compliance
- •Aged 11 years and over
- •Has a requirement for a micronutrient supplement
- •Written informed consent by subject or parent/carer
排除标准
- •Participants aged less than 11 years
- •Use of additional micronutrient supplements during the study period unless clinically indicated and prescribed by the investigator (must be recorded in patient case record file)
结局指标
主要结局
Palatability via qualitative assessments from a subject questionnaire
时间窗: 7 days
Qualitative outcome measures will be described in a narrative summarising the study outcomes
Gastrointestinal tolerance via qualitative assessments from a subject questionnaire
时间窗: 7 days
Qualitative outcome measures will be described in a narrative summarising the study outcomes
Patient compliance via qualitative assessments from a subject questionnaire
时间窗: 7 days
Qualitative outcome measures will be described in a narrative summarising the study outcomes
Ease of use of product via qualitative assessments from a subject questionnaire
时间窗: 7 days
Qualitative outcome measures will be described in a narrative summarising the study outcomes
次要结局
未报告次要终点