Phase 2 N=13 Randomized Treatment

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

Bottom Line

View on ClinicalTrials.gov: NCT01494051 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Apr 2020

Primary outcome: Primary: Energy Expenditure — 2045; 2343 kcal

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Diet counseling (Behavioral)
Age: Pediatric, Adult · 7+ yrs
Sex: All
Sponsor: Oregon Health and Science University
Primary completion: Sep 2009

Outcome Measures

Outcome	Result	p-value
PRIMARY Energy Expenditure	2045; 2343	—
SECONDARY Body Composition	-0.75; 0.78; 0.51; 0.43	—

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.

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

View full record on ClinicalTrials.gov →

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.