New dietary substitute shows promise for rare metabolic disorder
NCT ID NCT04761588
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested a special powdered food called TYR Sphere in 14 people with tyrosinemia or alkaptonuria. The goal was to see if patients would stick with it, tolerate it well, and keep their metabolic levels in check. Participants used the product for 4 weeks, and researchers tracked their intake, any stomach issues, and blood levels of key amino acids.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- TYR Sphere (a special powdered food substitute low in phenylalanine and tyrosine)
- What this could lead to
- If successful, TYR Sphere could offer a more acceptable dietary option for managing tyrosinemia and alkaptonuria, helping patients stick to their diet and maintain metabolic control.
- What could go wrong
- This is a very small study (14 participants) with no control group, so results may not apply to everyone. It only tested short-term use (4 weeks), so long-term benefits or risks are unknown.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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14 people
The number who actually took part.
- Started
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Dec 2021
- Finished
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Oct 2025
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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3 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Diagnosed with tyrosinaemia. * Aged ≥ 3 years. * In the opinion of the Investigator, can comply with the study protocol and take at least one sachet of the study product per day. * Willingly given, written, informed consent from patient or parent/guardian. * Willingly given, written assent (if appropriate). Exclusion Criteria: * Individuals who are allergic to milk, fish and soya (these allergens are inherent in the study product ingredients). * Use of additional macro/micronutrient supplements during the evaluation period, unless clinically indicated and prescribed by the Investigator (must be recorded in patient case report form CRF). * Women who are pregnant / breastfeeding at the start of the study or planning to become pregnant during the study. N.B.: Women who become pregnant during the study will no longer be able to participate and will be withdrawn. * Individuals who, in the opinion of the investigator, are unable to comply with the requirements of the protocol. * Any co-morbidity, which, in the opinion of the Investigator, would preclude participation in the study. * Patients who are currently participating in, plan to participate in, or have participated in an interventional investigational drug, food or medical device trial within 30 days prior to screening visit.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Hopital Necker-Enfants Malades
Paris, France
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Other studies related to the condition(s) this trial covers.