Evaluation of ZestiVits in Children and Adults on a Ketogenic or Restricted Therapeutic Diet

Study Overview
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Brief Summary
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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.

Detailed Description
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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. Qualitative assessments from subject questionnaires that allow evaluation of the acceptability and ease of use of the study product. Collection of daily data about the gastro-intestinal tolerance of the study product. Collection of daily data about compliance with the study product i.e. actual versus prescribed intake. Improve quality of life by increasing range of products available for use in a ketogenic or restricted therapeutic diet.

Official Title
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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

Conditions
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Deficiency of Micronutrients

Intervention / Treatment
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* Dietary Supplement: ZestiVits


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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)

Ages Eligible for Study
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Minimum Age: 11 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ZestiVits<br>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. | Dietary Supplement: ZestiVits<br>* The study product is a low-carbohydrate, orange flavour, vitamin, mineral and trace element (micronutrient) supplement for use in ketogenic and restricted therapeutic diets, for children aged from 11 years of age and adults. The recommended dosage of the study product for each subject will be determined and prescribed by a dietitian. This will be based on individual requirements for micronutrient supplementation.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Palatability via qualitative assessments from a subject questionnaire | Qualitative outcome measures will be described in a narrative summarising the study outcomes | 7 days | 
| Gastrointestinal tolerance via qualitative assessments from a subject questionnaire | Qualitative outcome measures will be described in a narrative summarising the study outcomes | 7 days | 
| Patient compliance via qualitative assessments from a subject questionnaire | Qualitative outcome measures will be described in a narrative summarising the study outcomes | 7 days | 
| Ease of use of product via qualitative assessments from a subject questionnaire | Qualitative outcome measures will be described in a narrative summarising the study outcomes | 7 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Micronutrients, restricted, ketogenic, diet, acceptability