Skip to main content
OpenTrials
Completed

NCT Number: 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 children aged 11 years and over and adults on a ketogenic or restricted therapeutic diet with regard to product tolerance, palatability and compliance.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Deficiency of Micronutrients

Age range

11 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bristol Royal Hospital for Children, Bristol, Avon, United Kingdom

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

Primary outcomes

  1. Palatability via qualitative assessments from a subject questionnaire

    Time frame: 7 days

    Qualitative outcome measures will be described in a narrative summarising the study outcomes

  2. Gastrointestinal tolerance via qualitative assessments from a subject questionnaire

    Time frame: 7 days

    Qualitative outcome measures will be described in a narrative summarising the study outcomes

  3. Patient compliance via qualitative assessments from a subject questionnaire

    Time frame: 7 days

    Qualitative outcome measures will be described in a narrative summarising the study outcomes

  4. Ease of use of product via qualitative assessments from a subject questionnaire

    Time frame: 7 days

    Qualitative outcome measures will be described in a narrative summarising the study outcomes

Sponsors and collaborators

Lead sponsor

Vitaflo International, Ltd

Industry

Registry information

Official study title

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

Acronym: ZestiVits

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jul 7, 2016
Registry last updated
Feb 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.