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Acceptability/Tolerance of Protein Substitutes in Tablet Form for the Dietary Management of Rare Aminoacidopathies

NCT06298292 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 15

Last updated 2024-03-07

No results posted yet for this study

Summary

The purpose of this prospective, observational study is to evaluate the tolerability and acceptability of Zero minis, a range of protein substitute tablets for use in the dietary management of children with either TYROSINAEMIA Type I, II, III or ALKAPTONURIA, HOMOCYSTINURIA, or MAPLE SYRUP URINE DISEASE (MSUD) over the age of 7 years.

Conditions

  • Tyrosinemia, Type I
  • Tyrosinemia, Type II
  • Tyrosinemia, Type III
  • Alkaptonuria
  • Homocystine; Metabolic Disorder
  • MSUD (Maple Syrup Urine Disease)

Interventions

DIETARY_SUPPLEMENT

Zero minis (range of protein substitutes in tablet form)

Intervention: range of protein substitute tablets. Subjects who currently take a protein substitute for the dietary management of either tyrosinaemias or alkaptonuria, homocystinuria, or MSUD will be recruited. Subjects will take the study product for 7 days. Daily questionnaires will be completed (ease of preparation,administration; any problems or gastrointestinal effects). Subjects will replace some or their entire usual protein substitute with the new product suitable for their diagnosed rare metabolic disease. The amount of tablets prescribed will be calculated to provide the same amount of protein as their usual protein substitute. Additional questions at the beginning and end of the study will record information on organoleptic properties, presentation and packaging of the product. Routine weekly blood samples will be collected and analysed for amino acids typically for the metabolic control of the individual specified metabolic disorders as is usual clinical practice.

Sponsors & Collaborators

  • Birmingham Women's and Children's NHS Foundation Trust

    collaborator OTHER

  • Great Ormond Street Hospital for Children NHS Foundation Trust

    collaborator OTHER

  • metaX Institut fuer Diatetik GmbH

    lead INDUSTRY

Principal Investigators

  • Anita MacDonald, Professor · Birmingham Children´s Hospital

Eligibility

Min Age
7 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-04-01
Primary Completion
2026-03-31
Completion
2026-06-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06298292 on ClinicalTrials.gov