Trial · NCT01034540
Effects of Prescription Omega-3 Acids on Glucose and Lipoprotein Lipids in Subjects With Hypertriglyceridemia
NCT01034540, Not applicable, Completed, Provident Clinical Research; results first posted 2013-10-22
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Effects of Prescription Omega-3 Acids on Glucose and Lipoprotein Lipids in Subjects With Hypertriglyceridemia. Trials, record NCT01034540. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01034540
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Effects of Prescription Omega-3 Acids on Glucose and Lipoprotein Lipids in Subjects With Hypertriglyceridemia
- NCT number
- NCT01034540
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 23 participants, actual
- Lead sponsor
- Provident Clinical Research
- Conditions
- Hypertriglyceridemia
- Interventions
- POM3, Placebo
- First posted
- 2009-12-17
- Last updated
- 2024-05-30
- Results first posted
- 2013-10-22
- Limitations and caveats
- Potential limitations: 1) relatively small sample size, and 2) relatively short length of wash-out period between treatments.
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Difference Between Treatments in Liquid Meal Tolerance Test (LMTT) Matsuda Insulin Sensitivity Index (MISI). | End of Treatment Intervention Period I (week 6) and End of Treatment Intervention Period II (week 14) | Liquid meal tolerance test (LMTT) = two 8 oz servings of Ensure (Abbott Nutrition) + study product followed by blood sample collection at -5, -1, 30, 60, 90, 120, 180, and 240 min, where t = 0 was start of liquid meal consumption. MISI calculated as 10,000/square root of (pre-meal glucose x pre-meal insulin x mean 120 min post-meal glucose x mean 120 min post-meal insulin) |
| Secondary | Difference Between Treatments in LMTT Insulin Secretion Index and Disposition Index. | End of Treatment Intervention Period I (week 6) and End of Treatment Intervention Period II (week 14) | Insulin secretion index = total area under the curve from 0 to 120 min post-meal for plasma insulin divided by total area under the curve from 0 to 120 min post-meal for plasma glucose. Disposition index = MISI x insulin secretion index |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Difference Between Treatments in Liquid Meal Tolerance Test (LMTT) Matsuda Insulin Sensitivity Index (MISI). | End of Treatment Intervention Period I (week 6) and End of Treatment Intervention Period II (week 14) | Per protocol population in which subjects with poor compliance, protocol violations, and without at least one post-randomization outcome data point during each treatment intervention period were removed. | Index value | MEDIAN |
| SECONDARY | Difference Between Treatments in LMTT Insulin Secretion Index and Disposition Index. | End of Treatment Intervention Period I (week 6) and End of Treatment Intervention Period II (week 14) | Per protocol population excluding subjects with poor compliance and protocol violations. | Index value | 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 |
|---|---|---|---|---|---|
| Difference Between Treatments in Liquid Meal Tolerance Test (LMTT) Matsuda Insulin Sensitivity Index (MISI). | Control | 3.2 | Inter-Quartile Range 1.9 to 7.1 | Index value | |
| Difference Between Treatments in Liquid Meal Tolerance Test (LMTT) Matsuda Insulin Sensitivity Index (MISI). | Prescription Omega-3 Acid Ethyl Esters | 3.3 | Inter-Quartile Range 2.0 to 7.4 | Index value | |
| Difference Between Treatments in LMTT Insulin Secretion Index and Disposition Index. | Control | Disposition index | 2.4 | Standard Error 0.25 | Index value |
| Difference Between Treatments in LMTT Insulin Secretion Index and Disposition Index. | Prescription Omega-3 Acid Ethyl Esters | Disposition index | 2.1 | Standard Error 0.20 | Index value |
| Difference Between Treatments in LMTT Insulin Secretion Index and Disposition Index. | Control | Insulin secretion index | 0.73 | Standard Error 0.09 | Index value |
| Difference Between Treatments in LMTT Insulin Secretion Index and Disposition Index. | Prescription Omega-3 Acid Ethyl Esters | Insulin secretion index | 0.66 | Standard Error 0.09 | Index value |
Source ClinicalTrials.gov
Participant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Prescription Omega-3 Acid Ethyl Esters/Placebo | 11 | |
| Overall Study | STARTED | Placebo/Prescription Omega-3 Acid Ethyl Esters | 12 | |
| Overall Study | Completed 1st Treatment Intervention | Prescription Omega-3 Acid Ethyl Esters/Placebo | 11 | |
| Overall Study | Completed 1st Treatment Intervention | Placebo/Prescription Omega-3 Acid Ethyl Esters | 11 | |
| Overall Study | COMPLETED | Prescription Omega-3 Acid Ethyl Esters/Placebo | 11 | |
| Overall Study | COMPLETED | Placebo/Prescription Omega-3 Acid Ethyl Esters | 11 | |
| Overall Study | NOT COMPLETED | Prescription Omega-3 Acid Ethyl Esters/Placebo | 0 | |
| Overall Study | NOT COMPLETED | Placebo/Prescription Omega-3 Acid Ethyl Esters | 1 |
Source ClinicalTrials.gov
Adverse events30
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 | Allergy aggravated | General disorders | POM3 | 0 | 23 | |
| other | Allergy aggravated | General disorders | Placebo | 1 | 23 | |
| other | Headache | Nervous system disorders | POM3 | 0 | 23 | |
| other | Headache | Nervous system disorders | Placebo | 1 | 23 | |
| other | Diarrhea | Gastrointestinal disorders | POM3 | 1 | 23 | |
| other | Diarrhea | Gastrointestinal disorders | Placebo | 0 | 23 | |
| other | Gastroesophageal reflux | Gastrointestinal disorders | POM3 | 0 | 23 | |
| other | Gastroesophageal reflux | Gastrointestinal disorders | Placebo | 1 | 23 | |
| other | SGOT Increased | Hepatobiliary disorders | POM3 | 0 | 23 | |
| other | SGOT Increased | Hepatobiliary disorders | Placebo | 1 | 23 |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | POM3 | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | POM3 | 2 | 23 |
| Total, other adverse events | Placebo | 7 | 23 |
| Total, serious adverse events | POM3 | 0 | 23 |
| Total, serious adverse events | Placebo | 0 | 23 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 21775113 | RESULT |
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 |
|---|
| POM3 vs Placebo: 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/NCT01034540
GET https://conductscience.org/api/trials/v1/NCT01034540/events?page=2