Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 209722 | Other Identifier | IRAS |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ZestiVits | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ZestiVits | Dietary Supplement | 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. |
| 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 |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Gisela Wilcox | Northern Care Alliance NHS Foundation Trust | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bristol Royal Hospital for Children | Bristol | Avon | BS2 8BJ | United Kingdom | ||
| Salford Royal NHS Foundation Trust |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Salford |
| Greater Manchester |
| M6 8HD |
| United Kingdom |
| Leeds Children's Hospital | Leeds | West Yorkshire | LS1 3EX | United Kingdom |