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

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

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.

Study Overview

• Status: Completed
• Conditions: Deficiency of Micronutrients
• Intervention / Treatment: Dietary supplement: ZestiVits

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.

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Avon
    • Bristol, Avon, United Kingdom, BS2 8BJ
      • Bristol Royal Hospital for Children
  • Greater Manchester
    • Salford, Greater Manchester, United Kingdom, M6 8HD
      • Salford Royal NHS Foundation Trust
  • West Yorkshire
    • Leeds, West Yorkshire, United Kingdom, LS1 3EX
      • Leeds Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Palatability via qualitative assessments from a subject questionnaire	Qualitative outcome measures will be described in a narrative summarising the study outcomes	7 days
Gastrointestinal tolerance via qualitative assessments from a subject questionnaire	Qualitative outcome measures will be described in a narrative summarising the study outcomes	7 days
Patient compliance via qualitative assessments from a subject questionnaire	Qualitative outcome measures will be described in a narrative summarising the study outcomes	7 days
Ease of use of product via qualitative assessments from a subject questionnaire	Qualitative outcome measures will be described in a narrative summarising the study outcomes	7 days

Collaborators and Investigators

• Sponsor: Vitaflo International, Ltd
• Investigators: Principal Investigator: Gisela Wilcox, Northern Care Alliance NHS Foundation Trust

Study record dates

Study Major Dates

• Study Start (Actual): February 17, 2017
• Primary Completion (Actual): August 31, 2018
• Study Completion (Actual): August 31, 2018

Study Registration Dates

• First Submitted: June 24, 2016
• First Submitted That Met QC Criteria: July 1, 2016
• First Posted (Estimated): July 7, 2016

Study Record Updates

• Last Update Posted (Actual): February 16, 2024
• Last Update Submitted That Met QC Criteria: February 15, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Micronutrients; diet; ketogenic; acceptability; restricted
• Other Study ID Numbers: MCT-Zest-14/01/2016-01; 209722 (Other Identifier: IRAS)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No