N/A
Completed N=26
Fatty Acid Oxidation Disorders & Body Weight Regulation Grant
Trifunctional Protein Deficiency
Source: ClinicalTrials.gov NCT00654004 ↗
Enrolled (actual)
26
Serious AEs
0.0%
Results posted
Apr 2013
Primary outcomePrimary: An Outcome of This Study is the Difference in Percent Body Fat (%BF) Between Subjects With a Long-chain Fatty Acid Oxidation Disorder and Normal Controls. — 31.8; 27.2 percentage of body fat
Summary
Several hormones involved in body weight regulation increase the subject's ability to burn fat for energy. The purpose of this study is to investigate how burning fat for energy may affect those hormones and body weight in children. The study will also determine if eating a diet higher in protein alters the amount of fat you burn and how these hormones control body weight.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY An Outcome of This Study is the Difference in Percent Body Fat (%BF) Between Subjects With a Long-chain Fatty Acid Oxidation Disorder and Normal Controls. |
31.8; 27.2 | — |
| PRIMARY An Outcome of This Study is the Difference in Glucose Tolerance Between Subjects With a Long-chain Fatty Acid Oxidation Disorder and Normal Controls. |
2.8; 3.13 | — |
| SECONDARY The Difference in Plasma Adiponectin Levels Between Subjects With a Long-chain Fatty Acid Oxidation Disorder and Matched Controls Was Compared by T-test |
17.3; 24.4 | — |
| SECONDARY The Difference in Plasma Leptin Between Subjects With a Long-chain Fatty Acid Oxidation Disorder and Matched Controls Was Compared by T-test |
0.99; 0.91 | — |
| SECONDARY The Difference in Plasma Insulin Between Subjects With a Long-chain Fatty Acid Oxidation Disorder and Matched Controls Was Compared by T-test |
17; 13 | — |
Eligibility Criteria
Inclusion Criteria
- confirmed diagnosis of TFP, LCHAD, CPT2 or VLCAD deficiency
- at least 7 years of age
- willingness to complete overnight admission
- generally healthy
Exclusion Criteria
- inclusion in another research project that alters macronutrient intake
- diabetes, thyroid disease or other endocrine dysfunction that alters body composition.
- pregnancy
- anemia
Data sourced from ClinicalTrials.gov (NCT00654004). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.