Deficiency of Micronutrients
Conditions
Keywords
Micronutrients, restricted, ketogenic, diet, acceptability
Brief summary
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
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.
Interventions
DIETARY_SUPPLEMENTZestiVits
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.
Sponsors
Vitaflo International, Ltd
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
11 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Diagnosis of condition requiring a ketogenic or restrictive therapeutic diet 2. On a ketogenic or restricted therapeutic diet with good compliance 3. Aged 11 years and over 4. Has a requirement for a micronutrient supplement 5. Written informed consent by subject or parent/carer
Exclusion criteria
1. Participants aged less than 11 years 2. 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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Palatability via qualitative assessments from a subject questionnaire | 7 days | Qualitative outcome measures will be described in a narrative summarising the study outcomes |
| Gastrointestinal tolerance via qualitative assessments from a subject questionnaire | 7 days | Qualitative outcome measures will be described in a narrative summarising the study outcomes |
| Patient compliance via qualitative assessments from a subject questionnaire | 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 | 7 days | Qualitative outcome measures will be described in a narrative summarising the study outcomes |
Countries
United Kingdom
Outcome results
None listed