Trial · NCT01379625
Study of Triheptanoin for Treatment of Long-Chain Fatty Acid Oxidation Disorder
NCT01379625, Phase 2, Completed, Oregon Health and Science University; results first posted 2017-03-23
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Study of Triheptanoin for Treatment of Long-Chain Fatty Acid Oxidation Disorder. Trials, record NCT01379625. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01379625
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Triheptanoin for Treatment of Long-Chain Fatty Acid Oxidation Disorder
- NCT number
- NCT01379625
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 32 participants, actual
- Lead sponsor
- Oregon Health and Science University
- Conditions
Very Long-chain acylCoA Dehydrogenase (VLCAD) Deficiency, Carnitine Palmitoyltransferase 2 (CPT2) Deficiency, Mitochondrial Trifunctional Protein (TFP) Deficiency, Long-chain 3 hydroxyacylCoA Dehydrogenase (LCHAD) Deficiency
- Interventions
- Triheptanoin
- First posted
- 2011-06-23
- Last updated
- 2017-03-23
- Results first posted
- 2017-03-23
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Energy Expenditure | change from baseline after 4 months of treatment | Total energy expenditure will be measured by doubly labeled water and resting energy expenditure will be measured by indirect calorimetry at baseline and again after 4 months of either MCT or trihpetanoin treatment. |
| Primary | Ejection Fraction | 4 months | Change in resting ejection fraction over 4 month treatment period |
| Secondary | Exercise Heart Rate | change from baseline to 4 months of treatment | Subjects will complete a submaximal treadmill exercise study at baseline. Exercise heart heart, ventilation and perceived exertion will be measured. Subjects will be randomized to MCT or triheptanoin supplementation for 4 months. At the end of treatment, the exercise test will be repeated keeping work performed constant. Change in exercise heart rate, ventilation and exertion will be compared between groups. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Energy Expenditure | change from baseline after 4 months of treatment | One subject in each group did not complete the doubly labeled water measures. A total of 15 in each group measured total energy expenditure at baseline and at the end of the study. This value compares the change over treatment. | kcal/day | MEAN |
| PRIMARY | Ejection Fraction | 4 months | Change in resting ejection fraction over 4 month treatment period calculated as: 4 month ejection fraction-baseline ejection fraction. Only participants with available data are included in this analysis. | percent | MEAN |
| SECONDARY | Exercise Heart Rate | change from baseline to 4 months of treatment | beats per minute | MEAN |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Energy Expenditure | Medium Chain Triglyceride (MCT) | -73 | Standard Deviation 335 | kcal/day | |
| Energy Expenditure | Triheptanoin | 107 | Standard Deviation 387 | kcal/day | |
| Ejection Fraction | Medium Chain Triglyceride (MCT) | -1.91 | Standard Deviation 4.16 | percent | |
| Ejection Fraction | Triheptanoin | 2.14 | Standard Deviation 4.43 | percent | |
| Exercise Heart Rate | Medium Chain Triglyceride (MCT) | -0.1 | Standard Deviation 9.6 | beats per minute | |
| Exercise Heart Rate | Triheptanoin | -12.6 | Standard Deviation 34 | beats per minute |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Medium Chain Triglyceride (MCT) | 16 | |
| Overall Study | STARTED | Triheptanoin | 16 | |
| Overall Study | COMPLETED | Medium Chain Triglyceride (MCT) | 16 | |
| Overall Study | COMPLETED | Triheptanoin | 16 | |
| Overall Study | NOT COMPLETED | Medium Chain Triglyceride (MCT) | 0 | |
| Overall Study | NOT COMPLETED | Triheptanoin | 0 |
Source ClinicalTrials.gov
Adverse events8
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Gastrointestinal Upset | Gastrointestinal disorders | Medium Chain Triglyceride (MCT) | 12 | 16 | 38 |
| other | Gastrointestinal Upset | Gastrointestinal disorders | Triheptanoin | 11 | 16 | 24 |
| other | Rhabdomyolysis | Musculoskeletal and connective tissue disorders | Medium Chain Triglyceride (MCT) | 4 | 16 | 7 |
| other | Rhabdomyolysis | Musculoskeletal and connective tissue disorders | Triheptanoin | 5 | 16 | 7 |
| other | Diarrhea/Loose stools | Gastrointestinal disorders | Medium Chain Triglyceride (MCT) | 6 | 16 | 12 |
| other | Diarrhea/Loose stools | Gastrointestinal disorders | Triheptanoin | 5 | 16 | 9 |
| other | muscle pain/ elevated CPK | Musculoskeletal and connective tissue disorders | Medium Chain Triglyceride (MCT) | 10 | 16 | 18 |
| other | muscle pain/ elevated CPK | Musculoskeletal and connective tissue disorders | Triheptanoin | 11 | 16 | 16 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Medium Chain Triglyceride (MCT) | ||
| Total, all-cause mortality | Triheptanoin | ||
| Total, other adverse events | Medium Chain Triglyceride (MCT) | 12 | 16 |
| Total, other adverse events | Triheptanoin | 11 | 16 |
| Total, serious adverse events | Medium Chain Triglyceride (MCT) | 0 | 16 |
| Total, serious adverse events | Triheptanoin | 0 | 16 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 28871440 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Medium Chain Triglyceride (MCT) vs Triheptanoin: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01379625
GET https://conductscience.org/api/trials/v1/NCT01379625/registered