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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief 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 Summary: 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.
Sponsor: Oregon Health and Science University

Current Primary Outcome: energy expenditure [ Time Frame: change from baseline after 4 months of treatment ]

does energy expenditure and substrate oxidation differ between subjects randomized to the high carbohydrate versus the high protein diet?


Original Primary Outcome: Same as current

Current Secondary Outcome: body composition [ Time Frame: change from baseline to 4 months of treatment ]

does body composition change more among subjects randomized to the high protein diet compared to the high carbohydrate diet?


Original Secondary Outcome: Same as current

Information By: Oregon Health and Science University

Dates:
Date Received: December 14, 2011
Date Started: January 2006
Date Completion:
Last Updated: December 15, 2011
Last Verified: December 2011