Phase 2
Completed N=13
High Protein Diet in Patients With Long-chain Fatty Acid Oxidation Disorders
Very Long-chain Acyl-CoA Dehydrogenase Deficiency · Trifunctional Protein Deficiency · Carnitine Palmitoyltransferase 2 Deficiency · Long-chain 3-hydroxyacyl-CoA Dehydrogenase Deficiency
Source: ClinicalTrials.gov NCT01494051 ↗
Enrolled (actual)
13
Serious AEs
0.0%
Results posted
Apr 2020
Primary outcomePrimary: Energy Expenditure — 2045; 2343 kcal
Summary
The study also determines if eating a diet higher in protein alters body composition, energy balance and metabolic control among patients with a long-chain fatty acid oxidation disorder.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Energy Expenditure |
2045; 2343 | — |
| SECONDARY Body Composition |
-0.75; 0.78; 0.51; 0.43 | — |
Eligibility Criteria
Inclusion Criteria
- diagnosis of a long-chain fatty acid oxidation disorder including VLCAD, CPT2, LCHAD or TFP deficiency
- 7 years old or greater
- able to comply with diet guidelines
Exclusion Criteria
- pregnant
- enrolled in another study that alters diet composition
- cannot complete treadmill exercise study
Data sourced from ClinicalTrials.gov (NCT01494051). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.