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
- 3
- 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)
研究组 & 干预措施
ZestiVits
Supplement for use in ketogenic and restricted therapeutic diets, from the age of 11.
Daily use for 7 days. Daily intake level for each subject will be determined and prescribed by a dietitian.
干预措施: ZestiVits (Dietary Supplement)
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