ZestiVits
Research type
Research Study
Full title
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.
IRAS ID
209722
Contact name
Gisela Wilcox
Contact email
Sponsor organisation
Vitaflo International Ltd
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 2 months, 2 days
Research summary
The ketogenic diet, although very effective in the dietary management of childhood epilepsy and similar or related syndromes and deficiencies, is extremely limited in terms of normal food choices. It mostly consists of fat (70-90%) which does not contain adequate amounts of the majority of all essential micronutrients: vitamins, minerals, trace elements and electrolytes. Routine, thorough supplementation is therefore required to prevent nutritional deficiencies occurring.\n\nThere are several other conditions that have a restricted diet as a mainstay of their management, such as inborn errors in metabolism, certain kidney and liver diseases and some food allergies. Supplements may be necessary due to the restrictions of the condition itself, loss of appetite while ill, difficulties in feeding or malabsorption.\n\nCurrently available supplements (prescription and over-the-counter) are typically either too low in the vitamin and mineral content or too high in carbohydrate content for patients on a ketogenic or other restricted diet.\nAnother consideration is the size of the tablets and capsules, which are typically too big for many people (children and adults alike) to swallow safely.\nThe quantity of the supplement that would be required to meet daily nutritional needs is typically quite high, in the currently available range, and so inconvenient to patients. Many also have a strong or offensive taste, which can be difficult to disguise.\n\nThe challenges described above have led to the development of ZestiVits, which has been designed to meet the specific needs of patients on the ketogenic or other restricted diets, optimising their nutrition. It is in a powdered form for mixing and also aims to be palatable.
REC name
North West - Preston Research Ethics Committee
REC reference
16/NW/0750
Date of REC Opinion
18 Oct 2016
REC opinion
Favourable Opinion