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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-02-17

Study Completion Date

2018-08-31

Brief Summary

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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.

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Detailed Description

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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

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Deficiency of Micronutrients

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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ZestiVits

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.

Group Type EXPERIMENTAL

ZestiVits

Intervention Type 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.

Interventions

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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.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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)

Minimum Eligible Age

11 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No