Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is a market research, observational study to evaluate the tolerability and acceptability of an MCT based formula for infants and young people with long chain fatty acid oxidation disorder from birth to 18 months. Patients with a confirmed diagnosis of a fatty acid oxidation disorder, which requires a specialist diet including MCT will be included in this study
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lipano MCT formula | Experimental | Kanso Lipano will be consumed daily for 3 months each to assess tolerability and compliance |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lipano formula | Dietary Supplement | Subjects will be asked to take an MCT infant formula to assess the tolerability, compliance and overall acceptability of the product for patient with LCHAD |
| Measure | Description | Time Frame |
|---|---|---|
| Gastrointestinal tolerance: questionnaire | Daily questionnaire detailing any GI symptoms, severity and change from usual The collection of daily data about the gastrointestinal tolerance of the product | 90 days |
| Product compliance | Daily questionnaire on amounts offered and amounts actually consumed, compared to recommended amount. | 90 days |
| Product palatability | Questionnaire data captured to evaluate taste | 90 days |
| Product acceptability | Brief tick-box questionnaire on overall liking and acceptability of product | 90 days |
| Measure | Description | Time Frame |
|---|---|---|
| Biochemistry stability - creatine kinase | creatine kinase will be monitored | 90 days |
| Biochemistry stability - liver enzymes | liver enzymes will be monitored |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Russian Children's Hospital Center for Orphan Diseases | Moscow | 117513 | Russia |
This study will be used to demonstrate acceptability for registration and reimbursement of these foods for special medical purposes.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 90 days |
| Anthropometry 1 | weight in g monitored to check growth | 90 days |
| Anthropometry 2 | height in cm monitored to check growth | 90 days |