NCT02825758

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Vitaflo International, Ltd · Industry
• Sex: All
• Age: 11 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Deficiency of Micronutrients

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	ZestiVits	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.

Timeline

• Start date: 2017-02-17
• Primary completion: 2018-08-31
• Completion: 2018-08-31
• First posted: 2016-07-07
• Last updated: 2024-02-16

Locations

3 sites across 1 country: United Kingdom