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

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ClinicalTrials.gov Identifier: NCT01494051
Recruitment Status : Completed
First Posted : December 16, 2011
Last Update Posted : December 16, 2011
Sponsor:
Information provided by (Responsible Party):
Melanie B Gillingham, Oregon Health and Science University

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.

Condition or disease Intervention/treatment Phase
Very Long-chain Acyl-CoA Dehydrogenase Deficiency Trifunctional Protein Deficiency Carnitine Palmitoyltransferase 2 Deficiency Long-chain 3-hydroxyacyl-CoA Dehydrogenase Deficiency Behavioral: Diet counseling Phase 1 Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 13 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Fatty Acid Oxidation and Body Weight Regulation in Long-chain Fatty Acid Oxidation Disorders.
Study Start Date : January 2006
Actual Primary Completion Date : September 2009
Actual Study Completion Date : January 2010


Arm Intervention/treatment
Active Comparator: High carbohydrate diet
Diet composition of 10% long-chain fatty acids, 20% medium-chain triglycerides, 12% protein and 68% carbohydrate is the current standard of care in long-chain fatty acid oxidation disorders.
Behavioral: Diet counseling
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

Experimental: High protein diet
Diet composition of 10% long-chain fatty acids, 20% medium chain triglycerides, 25% protein and 45% carbohydrate is the comparison diet. Fat content is the same between treatments; only the carbohydrate to protein ratio varies.
Behavioral: Diet counseling
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 Outcome Measures :
  1. 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?


Secondary Outcome Measures :
  1. 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?



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Ages Eligible for Study:   7 Years to 45 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Responsible Party: Melanie B Gillingham, Assistant Professor, Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT01494051     History of Changes
Other Study ID Numbers: DK71869-2
First Posted: December 16, 2011    Key Record Dates
Last Update Posted: December 16, 2011
Last Verified: December 2011

Keywords provided by Melanie B Gillingham, Oregon Health and Science University:
fatty acid oxidation disorders

Additional relevant MeSH terms:
Protein Deficiency
Lipid Metabolism, Inborn Errors
Cardiomyopathies
Rhabdomyolysis
Mitochondrial Myopathies
Metabolism, Inborn Errors
Muscular Diseases
Mitochondrial Diseases
Deficiency Diseases
Malnutrition
Nutrition Disorders
Genetic Diseases, Inborn
Lipid Metabolism Disorders
Metabolic Diseases
Heart Diseases
Cardiovascular Diseases
Musculoskeletal Diseases
Neuromuscular Diseases
Nervous System Diseases