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

Vitaflo

Status: Completed

Conditions: Deficiency of Micronutrients

Treatments: Dietary Supplement: ZestiVits

Study type: Interventional

Funder types: Industry

Identifiers

NCT02825758

MCT-Zest-14/01/2016-01

209722 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 15 patients

Sex: All

Ages: 11+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

ZestiVits

Experimental group

Description:

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.

Treatment:

Dietary Supplement: ZestiVits