Trial · NCT01661764
Fish Oil Supplementation, Nutrigenomics and Colorectal Cancer Prevention
NCT01661764, Phase 2, Completed, Vanderbilt University; results first posted 2018-05-08
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Fish Oil Supplementation, Nutrigenomics and Colorectal Cancer Prevention. Trials, record NCT01661764. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01661764
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Fish Oil Supplementation, Nutrigenomics and Colorectal Cancer Prevention
- NCT number
- NCT01661764
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 141 participants, actual
- Lead sponsor
- Vanderbilt University
- Conditions
- Colorectal Adenomatous Polyps
- Interventions
- Eicosapentanoic acid and docosahexanoic acid, Oleic Acid
- First posted
- 2012-08-09
- Last updated
- 2018-06-08
- Results first posted
- 2018-05-08
- Limitations and caveats
- Did not reach target accrual rate in T/T arm
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Rectal Epithelial Cell Proliferation | 6 month | The primary outcome of interest is rectal epithelial cell proliferation, as measured by Ki67 (mib-1) labeling. Expression of Ki-67 in colon epithelial cells will be detected following the standard IHC protocol of EnVision™+ System, HRP (DAKO). |
| Primary | Rectal Epithelial Cell Apoptosis | 6 months | The primary outcome of interest is rectal epithelial cell apoptosis as measured by TUNEL (TdT-mediated dUTP Nick-End Labeling). The TUNEL assay is conducted to measure apoptosis of colon epithelium using DeadEnd Colorimetric TUNEL System (Promega). After all fields of each sample are measured, the final immunoreaction indices are generated automatically by setting algorithms as ''total positive area / total nuclear area. Apoptotic activity is also scored using standard morphologic criteria applied to H\&E stained sections. |
| Secondary | Rectal Epithelial Cell COX-2 Expression | 6 months | Expression of COX-2 in rectal epithelial cells will be detected following the standard IHC protocol of EnVision™+ System, HRP (DAKO). |
| Secondary | Rectal Epithelial Cell 15-PGDH Expression | 6 months | Expression of 15-PGDH in rectal epithelial cells will be detected following the standard IHC protocol of EnVision™+ System, HRP (DAKO). |
| Secondary | Rectal Epithelial Cell Phospholipid Fatty Acid Content | 6 months | Lipids will be extracted using the method of Folch-Lees |
| Secondary | Rectal Epithelial Cell Production of PGE2 and PGE3 | 6 months | liquid chromatography/tandem mass spectrometric on rectal biopsy samples |
| Other | C-reactive Protein | 6 months | |
| Other | Adipokines | 6 months | leptin and adiponectin |
| Other | Insulin Sensitivity | 6 months | homeostasis model assessment-insulin resistance (HOMA-IR) HOMA-IR. Fasting insulin and glucose were be used to determine HOMA-IR: \[fasting glucose (mmol/l) x fasting insulin (µU/ml)\]/22.5\]", Optimal insulin sensitivity: \< 1, Early insulin resistance: \> 1.9, Significant insulin resistance: \> 2.9 |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Rectal Epithelial Cell Proliferation | 6 month | Patients with before and after rectal biopsies | percentage of cells positive | MEAN |
| PRIMARY | Rectal Epithelial Cell Apoptosis | 6 months | percentage of cells positive | MEAN | |
| SECONDARY | Rectal Epithelial Cell COX-2 Expression | 6 months | percentage of cells positive | MEAN | |
| SECONDARY | Rectal Epithelial Cell 15-PGDH Expression | 6 months | percentage of cells positive | MEAN | |
| SECONDARY | Rectal Epithelial Cell Phospholipid Fatty Acid Content | 6 months | Due to inadequate rectal tissue specimens we were unable to measure rectal tissue phospholipids | ||
| SECONDARY | Rectal Epithelial Cell Production of PGE2 and PGE3 | 6 months | For some participants the volume of frozen tissue was not enough to measure rectal eicosanoids and are not included in the analysis (2 from GG, fish oil, 2 from GG, placebo, 3 from GT fish oil, 4 GT placebo, 1 TT fish oil and 3 TT placebo) | ng/g | MEAN |
| OTHER_PRE_SPECIFIED | C-reactive Protein | 6 months | mg/L | MEAN | |
| OTHER_PRE_SPECIFIED | Adipokines | 6 months | Adipokines were not measured on all trial participants due to assay expense. Samples measurements were not completed on 3 GG, fish oil, 0 GG, placebo, 3 GT fish oil, 4 GT placebo, 7 TT fish oil, 9 TT placebo | ng/mL | MEAN |
| OTHER_PRE_SPECIFIED | Insulin Sensitivity | 6 months | HOMA-IR Index | MEAN |
Source ClinicalTrials.gov
Results by group60
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Rectal Epithelial Cell Proliferation | rs174535 (GG), Fish Oil Supplements | 19.3 | Standard Deviation 6.8 | percentage of cells positive | |
| Rectal Epithelial Cell Proliferation | rs174535 (GG), Placebo | 20.3 | Standard Deviation 7.6 | percentage of cells positive | |
| Rectal Epithelial Cell Proliferation | rs174535 (GT), Fish Oil Supplements | 18.9 | Standard Deviation 8.5 | percentage of cells positive | |
| Rectal Epithelial Cell Proliferation | rs174535 (GT), Placebo | 16.8 | Standard Deviation 6.2 | percentage of cells positive | |
| Rectal Epithelial Cell Proliferation | rs174535 (TT), Fish Oil Supplement | 15.7 | Standard Deviation 5.4 | percentage of cells positive | |
| Rectal Epithelial Cell Proliferation | rs174535 (TT), Placebo | 20.8 | Standard Deviation 6.7 | percentage of cells positive | |
| Rectal Epithelial Cell Apoptosis | rs174535 (GG), Fish Oil Supplements | 1.17 | Standard Deviation 1.79 | percentage of cells positive | |
| Rectal Epithelial Cell Apoptosis | rs174535 (GG), Placebo | 1.30 | Standard Deviation 1.30 | percentage of cells positive | |
| Rectal Epithelial Cell Apoptosis | rs174535 (GT), Fish Oil Supplements | 1.00 | Standard Deviation 1.27 | percentage of cells positive | |
| Rectal Epithelial Cell Apoptosis | rs174535 (GT), Placebo | 2.61 | Standard Deviation 4.55 | percentage of cells positive |
1 to 10 of 60Source ClinicalTrials.gov
See all 60 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | rs174535 (GG), Fish Oil Supplements | 26 | |
| Overall Study | STARTED | rs174535 (GG), Placebo | 25 | |
| Overall Study | STARTED | rs174535 (GT), Fish Oil Supplements | 25 | |
| Overall Study | STARTED | rs174535 (GT), Placebo | 26 | |
| Overall Study | STARTED | rs174535 (TT), Fish Oil Supplement | 19 | |
| Overall Study | STARTED | rs174535 (TT), Placebo | 20 | |
| Overall Study | COMPLETED | rs174535 (GG), Fish Oil Supplements | 24 | |
| Overall Study | COMPLETED | rs174535 (GG), Placebo | 20 | |
| Overall Study | COMPLETED | rs174535 (GT), Fish Oil Supplements | 22 | |
| Overall Study | COMPLETED | rs174535 (GT), Placebo | 24 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events12
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 | Bloating and eructations | Gastrointestinal disorders | rs174535 (GG), Fish Oil Supplements | 1 | 26 | 1 |
| other | Bloating and eructations | Gastrointestinal disorders | rs174535 (GG), Placebo | 0 | 25 | 0 |
| other | Bloating and eructations | Gastrointestinal disorders | rs174535 (GT), Fish Oil Supplements | 0 | 25 | 0 |
| other | Bloating and eructations | Gastrointestinal disorders | rs174535 (GT), Placebo | 0 | 26 | 0 |
| other | Bloating and eructations | Gastrointestinal disorders | rs174535 (TT), Fish Oil Supplement | 2 | 19 | 2 |
| other | Bloating and eructations | Gastrointestinal disorders | rs174535 (TT), Placebo | 1 | 20 | 1 |
| serious | Myocardial Infarction | Cardiac disorders | rs174535 (GG), Fish Oil Supplements | 0 | 26 | |
| serious | Myocardial Infarction | Cardiac disorders | rs174535 (GG), Placebo | 1 | 25 | |
| serious | Myocardial Infarction | Cardiac disorders | rs174535 (GT), Fish Oil Supplements | 0 | 25 | |
| serious | Myocardial Infarction | Cardiac disorders | rs174535 (GT), Placebo | 0 | 26 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse eventsAdverse event totals18
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | rs174535 (GG), Fish Oil Supplements | 0 | 26 |
| Total, all-cause mortality | rs174535 (GG), Placebo | 0 | 25 |
| Total, all-cause mortality | rs174535 (GT), Fish Oil Supplements | 0 | 25 |
| Total, all-cause mortality | rs174535 (GT), Placebo | 0 | 26 |
| Total, all-cause mortality | rs174535 (TT), Fish Oil Supplement | 0 | 19 |
| Total, all-cause mortality | rs174535 (TT), Placebo | 0 | 20 |
| Total, other adverse events | rs174535 (GG), Fish Oil Supplements | 1 | 26 |
| Total, other adverse events | rs174535 (GG), Placebo | 0 | 25 |
| Total, other adverse events | rs174535 (GT), Fish Oil Supplements | 0 | 25 |
| Total, other adverse events | rs174535 (GT), Placebo | 0 | 26 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 34291724 | DERIVED |
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 |
|---|---|---|---|---|---|
| R01CA160938 | Fatty acid desaturase activity, fish oil and colorectal cancer chemoprevention | MURFF, HARVEY J. | VANDERBILT UNIVERSITY MEDICAL CENTER | NATIONAL CANCER INSTITUTE | 2011 to 2014 |
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/NCT01661764
GET https://conductscience.org/api/trials/v1/NCT01661764/results?page=2