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

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.

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Key information

Conditions

Very Long-chain Acyl-CoA Dehydrogenase Deficiency Carnitine Palmitoyltransferase 2 Deficiency Carnitine palmitoyl transferase 2 deficiency Long-chain 3-hydroxyacyl-CoA Dehydrogenase Deficiency Trifunctional Protein Deficiency Trifunctional Protein Deficiency With Myopathy And Neuropathy VLCAD deficiency

Age range

7 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Diet Counseling

Behavioral

Subjects counseled how to follow either the high carbohydrate diet or the high protein diet for 4 months at home.

Other names: low fat diet, high carbohydrate diet, high protein diet

Primary outcomes

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? We measured resting energy expenditure with indirect calorimetry and estimated substrate oxidation with indirect calorimetry results and urine urea nitrogen excretion. We also measured total energy expenditure with doubly labeled water.

Secondary outcomes

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? We measured body composition at baseline and again at the end of the study by DEXA - dual energy x-ray absorptiometry.

Sponsors and collaborators

Lead sponsor

Oregon Health and Science University

Other

Registry information

Official study title

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

Important dates

Study start: 2006
Primary completion: 2009
Study completion: 2010
First posted: Dec 16, 2011
Registry last updated: Apr 29, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed