Table 4.
Summary of ongoing and recently completed clinical trials.
| Status; ClinicalTrials.gov Identifier | Title | Study design | Indication | Diet and intervention | Primary endpoint |
|---|---|---|---|---|---|
| Recruiting; NCT02534389 | Fish oil supplement combined with neoadjuvant chemoradiation for locally advanced rectal cancer | I, R, OP | Rectal neoplasm | Omega-3 fish oil, 2.4 g of EPA + DHA vs. no intervention | Effects of daily consumption of 2.4 g of EPA + DHA for adults with rectal adenocarcinoma in neoadjuvant chemoradiation treatment on Glasgow Prognostic Score |
| Active, not recruiting; NCT02699047 | Gastrointestinal cancer: effects of the fish oil intake on nutritional status, quality of life and immune and metabolic outcomes | I, R, DB | GI cancer, CRC, stomach cancer | Encapsulated fish oil vs. encapsulated olive oil | Change in quality of life, inflammatory response, body weight, body mass index, serum C-reactive protein, tumor markers (CEA, CA-19), serum albumin, survival and others |
| Active, not recruiting; NCT01661764 | Fatty acid desaturase activity, fish oil and colorectal cancer prevention | I, R, DB | Adenomatous colorectal polyps | EPA and DHA vs. oleic acid | Rectal epithelial cell, proliferation, rectal epithelial cell apoptosis |
| Recruiting; NCT02179372 | Modulation of fecal calprotectin by eicosapentaenoic free fatty acid in inflammatory bowel diseases | I, R, DB | UC, CD | EPA vs. MCFA (placebo) | Changes in FC levels |
| Completed; NCT02069561 | Effects of eicosapentaenoic acid on molecular, metabonomics and intestinal microbiota changes, in subjects with long-standing inflammatory bowel disease | I, non-R, OP | UC | EPA vs. no intervention | Changes in RNA profiles, DNA methylation profiles, in cell proliferation and apoptosis |
| Completed; NCT02349594 | Modulation of immune function by parenteral fish oil in patients with Crohn's disease and high inherent tumor necrosis factor-alpha production: a randomized, single blinded, cross-over study | I, R, SB | CD | Omegaven 10% vs. Intralipid 20% | Change in TNF-α production (pg/ml) |
CA-19, cancer antigen 19; CD, Crohn's disease; CEA, carcinoembryonic antigen; CRC, colorectal cancer; DHA, docosahexaenoic acid; EPA, eicosapentaenoic acid; FC, fecal calprotectin; GI, gastrointestinal; MCFA, medium chain fatty acid; UC, ulcerative colitis.
Study design: DB, double blinded; I, interventional; non-R, non randomized; OP, open label; R, randomized; SB, single blinded.