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Clinical Trials/NCT01494051
NCT01494051CompletedPhase 1

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

Oregon Health and Science University0 sites13 target enrollmentStarted: January 2006Last updated:
Conditions

Trial Snapshot

Phase
Phase 1
Status
Completed
Enrollment
13
Primary Endpoint
Energy Expenditure

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
7 Years to 45 Years (Child, Adult)
Sex
All
Accepts Healthy Volunteers
No

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

  • enrolled in another study that alters diet composition
  • cannot complete treadmill exercise study

Outcomes

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(change from baseline to 4 months of treatment)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Melanie B Gillingham

Assistant Professor

Oregon Health and Science University

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