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

NCT ID: NCT01494051

Last Updated: 2020-04-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 13 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-01-31
• Study Completion Date: 2010-01-31

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 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Diet counseling

Intervention Type: BEHAVIORAL

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

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.

Group Type: EXPERIMENTAL

Diet counseling

Intervention Type: BEHAVIORAL

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

Interventions

Diet counseling

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

Intervention Type: BEHAVIORAL

Other Intervention Names

low fat diet; high carbohydrate diet; high protein diet

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

• Minimum Eligible Age: 7 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Oregon Health and Science University

OTHER

Sponsor Role: lead

Responsible Party

Melanie B Gillingham

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

DK71869-2

Identifier Type: -

Identifier Source: org_study_id