NCT01494051

High Protein Diet in Patients With Long-chain Fatty Acid Oxidation Disorders

Fatty Acid Oxidation and Body Weight Regulation in Long-chain Fatty Acid Oxidation Disorders.

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: Oregon Health and Science University · Academic / Other
• Sex: All
• Age: 7 Years – 45 Years
• Healthy volunteers: Not accepted

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.

Detailed description

At baseline, the amount of muscle and fat in the whole body and inside the liver and muscle will be measured. All subjects will complete a moderate treadmill exercise test and a test to determine how they use sugar (oral glucose tolerance test). The amount and type of energy burned by each subject will be measured. Subjects will be randomly assigned to follow either a high carbohydrate diet or a reduced carbohydrate, high protein diet for 4 months. At the end of 4 months, the tests will be repeated.

Conditions

• Very Long-chain Acyl-CoA Dehydrogenase Deficiency
• Trifunctional Protein Deficiency
• Carnitine Palmitoyltransferase 2 Deficiency
• Long-chain 3-hydroxyacyl-CoA Dehydrogenase Deficiency

Interventions

Type	Name	Description
BEHAVIORAL	Diet counseling	Subjects counseled how to follow either the high carbohydrate diet or the high protein diet for 4 months at home.

Timeline

• Start date: 2006-01-01
• Primary completion: 2009-09-01
• Completion: 2010-01-01
• First posted: 2011-12-16
• Last updated: 2020-04-29
• Results posted: 2020-04-21