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

NCT01494051 | Completed Phase 1 Results

• 1 other identifier: DK71869-2
• Study Type: interventional
• Target: 13
• Locations: 0 countries
• Sites: N/A

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.

Conditions

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

Keywords

fatty acid oxidation disorders

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Body Composition

  change from baseline to 4 months of treatment

Study Arms (2)

High carbohydrate diet

ACTIVE COMPARATOR

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

High protein diet

EXPERIMENTAL

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

Interventions

Diet counseling BEHAVIORAL

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

Also known as: low fat diet, high carbohydrate diet, high protein diet

High carbohydrate diet; High protein diet

Eligibility Criteria

• Age: 7 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• diagnosis of a long-chain fatty acid oxidation disorder including VLCAD, CPT2, LCHAD or TFP deficiency
• years old or greater
• able to comply with diet guidelines

You may not qualify if:

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

Sponsors & Collaborators

• Oregon Health and Science University: lead

MeSH Terms

Conditions

VLCAD deficiency; Trifunctional Protein Deficiency With Myopathy And Neuropathy; Carnitine palmitoyl transferase 2 deficiency

Interventions

Diet, Fat-Restricted; Diet, High-Protein Low-Carbohydrate; Diet, High-Protein

Intervention Hierarchy (Ancestors)

Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Diet, Carbohydrate-Restricted

Results Point of Contact

• Title: Dr. Melanie Gillingham
• Organization: Oregon Health & Science University

gillingm@ohsu.edu

503-494-1682

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: December 14, 2011
• First Posted: December 16, 2011
• Study Start: January 1, 2006
• Primary Completion: September 1, 2009
• Study Completion: January 1, 2010
• Last Updated: April 29, 2020
• Results First Posted: April 21, 2020

Record last verified: 2020-04