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

Long-chain 3-hydroxyacyl-CoA Dehydrogenase Deficiency Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01494051
• Other study ID #: DK71869-2
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: January 2006
• Est. completion date: January 2010

Study information

• Verified date: April 2020
• Source: Oregon Health and Science University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: January 2010
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Behavioral:
• Diet counseling
Subjects counseled how to follow either the high carbohydrate diet or the high protein diet for 4 months at home.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Oregon Health and Science University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Energy Expenditure	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.	change from baseline after 4 months of treatment
Secondary	Body Composition	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.	change from baseline to 4 months of treatment