Trial · NCT03301532
Compatibility of C7 With Ketogenic Diet in Patients Diagnosed With G1D
NCT03301532, Phase 2, Completed, University of Texas Southwestern Medical Center; results first posted 2024-01-17
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Compatibility of C7 With Ketogenic Diet in Patients Diagnosed With G1D. Trials, record NCT03301532. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03301532
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Compatibility of C7 With Ketogenic Diet in Patients Diagnosed With G1D
- NCT number
- NCT03301532
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 10 participants, actual
- Lead sponsor
- University of Texas Southwestern Medical Center
- Conditions
- GLUT1DS1
- Interventions
- Triheptanoin
- First posted
- 2017-10-04
- Last updated
- 2024-01-17
- Results first posted
- 2024-01-17
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Ketosis (Beta-hydroxybutyrate Levels) | Day 1, Day 4 | Change in Ketosis as measured by changes in blood beta-hydroxybutyric acid levels. |
| Secondary | Fraction of Subjects (of a Total of 10 Studied) Who Exhibit a Change in Observable Seizure Rate | Baseline (Day 1) - Day 4 | The percent change in observable seizure rate is measured as the change in observable seizure numbers from baseline to Day 4. Seizure rate is defined as count of seizures per patient per day. |
| Secondary | Change in Glycemia | Day 1 - Day 4 | Change in Glycemia is measured as changes in blood glucose levels. |
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 | Change in Ketosis (Beta-hydroxybutyrate Levels) | Day 1, Day 4 | Subjects with Glut1 deficency | mM | MEAN |
| SECONDARY | Fraction of Subjects (of a Total of 10 Studied) Who Exhibit a Change in Observable Seizure Rate | Baseline (Day 1) - Day 4 | All subjects with Glut1 deficiency studied. Triheptanoin (C7 oil, liquid). Subjects consumed triheptanoin 4 times over the course of one day. The approach included substituting a fraction of ketogenic diet fat with C7, weight by weight, at the maximum tolerable dose (45% of their their daily calories) in individuals receiving a ketogenic diet prior to enrolment prescribed independently of this study. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change in Glycemia | Day 1 - Day 4 | mg/dl | MEAN |
Source ClinicalTrials.gov
Results by group3
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in Ketosis (Beta-hydroxybutyrate Levels) | Ketosis | 3.82 | Standard Deviation 1.9 | mM | |
| Fraction of Subjects (of a Total of 10 Studied) Who Exhibit a Change in Observable Seizure Rate | Fraction of Subjects With a Change in Seizure Rate | 3 | Participants | ||
| Change in Glycemia | Glycemia | 81.2 | Standard Deviation 13.6 | mg/dl |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Experimental: Triheptanoin (C7) | 10 | |
| Overall Study | COMPLETED | Experimental: Triheptanoin (C7) | 10 | |
| Overall Study | NOT COMPLETED | Experimental: Triheptanoin (C7) | 0 |
Source ClinicalTrials.gov
Adverse events1
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 | Seizures | Nervous system disorders | Ketosis | 2 | 10 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Ketosis | 0 | 10 |
| Total, other adverse events | Ketosis | 2 | 10 |
| Total, serious adverse events | Ketosis | 0 | 10 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 37268656 | RESULT |
Source PubMed
Grants1
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| R01NS094257 | Dietary treatment of Glut1 deficiency (G1D) - Revision - 1 | PASCUAL, JUAN M. | UT SOUTHWESTERN MEDICAL CENTER | NATIONAL INSTITUTE OF NEUROLOGICAL DISORDERS AND STROKE | 2016 to 2021 |
Source NIH RePORTER
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT03301532
GET https://conductscience.org/api/trials/v1/NCT03301532/registered