Evidence map›Paper›PMID 42349681›Full record

Trial reportThe American journal of clinical nutrition2026

Effect of icosapent ethyl treatment on colorectal tissue marine ω-3 polyunsaturated fatty acid levels among patients with a history of adenoma: a prospective, single-arm clinical trial.

Yufeng Chen, Sunjeong Bae, Kai Wang, Mengxi Du, Yujia Lu, Qi Sun, Perry A Labelle, Alexander Caraballo, Kylor Lachut, Alina Husain and 30 more

Registry-linked trialAbstract readClinical Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in The American journal of clinical nutrition, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04216251 (PREPARE), which is not on this map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04216251 phase1 / phase2completednot on this map

PREPARE: PRevention Using EPA Against coloREctal Cancer

TypeinterventionalSponsorMassachusetts General HospitalRan2020 to 2022Enrolled81ConditionsColorectal Adenoma, Colorectal Cancer, Endoscopic Surgery, Eicosapentaenoic AcidArmsAMR101
3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

40 authors.

Yufeng ChenClinical and Translational Epidemiology Unit, Massachusetts General Hospital, Boston, MA, United States; Department of Epidemiology, Harvard T.H. Chan School of Public Health, Boston, MA, United States; Department of General Surgery (Colorectal Surgery), Guangdong Provincial Key Laboratory of Colorectal and Pelvic Floor Diseases, Guangzhou (Huangpu) Zhongliu Biomedical Innovation Center, and Guangdong Provincial Clinical Research Center for Digestive Diseases, The Sixth Affiliated Hospital, Sun Yat-sen University, Guangzhou, Guangdong, China.
Sunjeong BaeDepartment of Epidemiology, Harvard T.H. Chan School of Public Health, Boston, MA, United States.
Kai WangClinical and Translational Epidemiology Unit, Massachusetts General Hospital, Boston, MA, United States; Department of Epidemiology, Harvard T.H. Chan School of Public Health, Boston, MA, United States.
Mengxi DuClinical and Translational Epidemiology Unit, Massachusetts General Hospital, Boston, MA, United States; Department of Epidemiology, Harvard T.H. Chan School of Public Health, Boston, MA, United States; Department of Nutrition, Harvard T.H. Chan School of Public Health, Boston, MA, United States.
Yujia LuDepartment of Epidemiology, Harvard T.H. Chan School of Public Health, Boston, MA, United States.
Qi SunDepartment of Epidemiology, Harvard T.H. Chan School of Public Health, Boston, MA, United States; Department of Nutrition, Harvard T.H. Chan School of Public Health, Boston, MA, United States; Channing Division of Network Medicine, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, United States.
Perry A LabelleClinical and Translational Epidemiology Unit, Massachusetts General Hospital, Boston, MA, United States; Division of Gastroenterology, Massachusetts General Hospital, Boston, MA, United States.
Alexander CaraballoClinical and Translational Epidemiology Unit, Massachusetts General Hospital, Boston, MA, United States; Division of Gastroenterology, Massachusetts General Hospital, Boston, MA, United States.
Kylor LachutClinical and Translational Epidemiology Unit, Massachusetts General Hospital, Boston, MA, United States; Division of Gastroenterology, Massachusetts General Hospital, Boston, MA, United States.
Alina HusainClinical and Translational Epidemiology Unit, Massachusetts General Hospital, Boston, MA, United States; Division of Gastroenterology, Massachusetts General Hospital, Boston, MA, United States.
Liza HoteClinical and Translational Epidemiology Unit, Massachusetts General Hospital, Boston, MA, United States; Division of Gastroenterology, Massachusetts General Hospital, Boston, MA, United States.
Madeline KoehnClinical and Translational Epidemiology Unit, Massachusetts General Hospital, Boston, MA, United States; Division of Gastroenterology, Massachusetts General Hospital, Boston, MA, United States.
Elizabeth PreziosoClinical and Translational Epidemiology Unit, Massachusetts General Hospital, Boston, MA, United States; Division of Gastroenterology, Massachusetts General Hospital, Boston, MA, United States.
Trenton ReinickeClinical and Translational Epidemiology Unit, Massachusetts General Hospital, Boston, MA, United States; Division of Gastroenterology, Massachusetts General Hospital, Boston, MA, United States.
Madeline SchuckClinical and Translational Epidemiology Unit, Massachusetts General Hospital, Boston, MA, United States; Division of Gastroenterology, Massachusetts General Hospital, Boston, MA, United States.
Janavi SethurathnamClinical and Translational Epidemiology Unit, Massachusetts General Hospital, Boston, MA, United States; Division of Gastroenterology, Massachusetts General Hospital, Boston, MA, United States.
Julia SoloweyClinical and Translational Epidemiology Unit, Massachusetts General Hospital, Boston, MA, United States; Division of Gastroenterology, Massachusetts General Hospital, Boston, MA, United States.
Jacqueline WooClinical and Translational Epidemiology Unit, Massachusetts General Hospital, Boston, MA, United States; Division of Gastroenterology, Massachusetts General Hospital, Boston, MA, United States.
Peter J CarolanDivision of Gastroenterology, Massachusetts General Hospital, Boston, MA, United States.
Daniel C ChungDivision of Gastroenterology, Massachusetts General Hospital, Boston, MA, United States; Center for Cancer Risk Assessment, Massachusetts General Hospital, Boston, MA, United States.
Francis P ColizzoDivision of Gastroenterology, Massachusetts General Hospital, Boston, MA, United States.
Manish GalaClinical and Translational Epidemiology Unit, Massachusetts General Hospital, Boston, MA, United States; Division of Gastroenterology, Massachusetts General Hospital, Boston, MA, United States.
Hamed KhaliliClinical and Translational Epidemiology Unit, Massachusetts General Hospital, Boston, MA, United States; Division of Gastroenterology, Massachusetts General Hospital, Boston, MA, United States; Broad Institute of MIT and Harvard, Cambridge, MA, United States; Institute of Environmental Medicine, Karolinska Institute, Stockholm, Sweden; Crohn's and Colitis Center, Massachusetts General Hospital, Boston, MA, United States.
Norman S NishiokaDivision of Gastroenterology, Massachusetts General Hospital, Boston, MA, United States.
James M RichterDivision of Gastroenterology, Massachusetts General Hospital, Boston, MA, United States.
Kyle StallerDivision of Gastroenterology, Massachusetts General Hospital, Boston, MA, United States.
Joseph C YarzeDivision of Gastroenterology, Massachusetts General Hospital, Boston, MA, United States.
Wenjie MaClinical and Translational Epidemiology Unit, Massachusetts General Hospital, Boston, MA, United States; Division of Gastroenterology, Massachusetts General Hospital, Boston, MA, United States.
Daniel PrattDivision of Gastroenterology, Massachusetts General Hospital, Boston, MA, United States; Autoimmune and Cholestatic Liver Center, Massachusetts General Hospital, Boston, MA, United States.
Amandeep SinghDivision of Gastroenterology, Massachusetts General Hospital, Boston, MA, United States.
Long H NguyenClinical and Translational Epidemiology Unit, Massachusetts General Hospital, Boston, MA, United States; Division of Gastroenterology, Massachusetts General Hospital, Boston, MA, United States.
Brian C JacobsonDivision of Gastroenterology, Massachusetts General Hospital, Boston, MA, United States.
Jay LutherDivision of Gastroenterology, Massachusetts General Hospital, Boston, MA, United States.
Braden KuoCenter for Digestive and Liver Disease, Vagelos College of Physicians and Surgeons, Columbia University, New York, NY, United States.
Michael DouganDivision of Gastroenterology, Massachusetts General Hospital, Boston, MA, United States.
Bernard RosnerDivision of Gastroenterology, Massachusetts General Hospital, Boston, MA, United States; Department of Biostatistics, Harvard T.H. Chan School of Public Health, Boston, MA, United States.
Marina Magicheva-GuptaClinical and Translational Epidemiology Unit, Massachusetts General Hospital, Boston, MA, United States; Division of Gastroenterology, Massachusetts General Hospital, Boston, MA, United States.
David A DrewClinical and Translational Epidemiology Unit, Massachusetts General Hospital, Boston, MA, United States; Division of Gastroenterology, Massachusetts General Hospital, Boston, MA, United States.
Andrew T ChanClinical and Translational Epidemiology Unit, Massachusetts General Hospital, Boston, MA, United States; Department of Epidemiology, Harvard T.H. Chan School of Public Health, Boston, MA, United States; Channing Division of Network Medicine, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, United States; Division of Gastroenterology, Massachusetts General Hospital, Boston, MA, United States; Broad Institute of MIT and Harvard, Cambridge, MA, United States; Department of Immunology and Infectious Diseases, Harvard T.H. Chan School of Public Health, Boston, MA, United States.
Mingyang SongClinical and Translational Epidemiology Unit, Massachusetts General Hospital, Boston, MA, United States; Department of Epidemiology, Harvard T.H. Chan School of Public Health, Boston, MA, United States; Department of Nutrition, Harvard T.H. Chan School of Public Health, Boston, MA, United States; Division of Gastroenterology, Massachusetts General Hospital, Boston, MA, United States; Broad Institute of MIT and Harvard, Cambridge, MA, United States. Electronic address: msong@hsph.harvard.edu.

Funding

The Gut Microbiome, Lifestyle, and Colorectal NeoplasiaU01CA261961 · NCI · HARVARD UNIVERSITY D/B/A HARVARD SCHOOL OF PUBLIC HEALTH · PI Mingyang Song · 2022 to 2026
$3.0M
Marine Omega-3 Polyunsaturated Fatty Acid, Gut Microbiome, and Colorectal Cancer PreventionR00CA215314 · NCI · HARVARD SCHOOL OF PUBLIC HEALTH · PI SONG, MINGYANG · 2018 to 2020
$679k
NCI NIH HHS R00 CA215314NCI NIH HHS U01 CA261961
6 · The paper itself

Abstract

backgroundIcosapent ethyl (IPE), an ethyl ester of eicosapentaenoic acid (EPA; C20:5n-3), is thought to have immunomodulatory properties and may protect against colorectal cancer.

objectivesThis study aimed to assess the effect of IPE on changing total marine omega-3 (n-3) polyunsaturated fatty acid (PUFA) and individual fatty acid composition in colorectal tissue.

methodsWe conducted a prospective, single-arm clinical trial of 4 g/d IPE (VASCEPA) treatment for 8 to 12 wk among patients with a recent history of adenoma. We collected pretreatment and posttreatment colorectal biopsies through flexible sigmoidoscopy and participants' diet and lifestyle via questionnaires. The primary outcome was the change in total marine ω-3 PUFA in colorectal tissue measured by gas-liquid chromatography. We examined changes in individual fatty acids exploratorily.

resultsAmong a total of 81 patients enrolled, 72 had paired pretreatment and posttreatment tissue fatty acid data. After intervention, the tissue composition [median (interquartile range)] of total marine ω-3 PUFA increased from 2.10% (0.96%) to 5.21% (1.97%), with a fold change of 2.40 (0.82). With a slight decrease in ω-6 PUFA [fold change = 0.96 (0.27)], the ratio of marine ω-3 to ω-6 PUFA increased [fold change = 2.58 (0.81)]. Among individual fatty acids, EPA increased the most [fold change = 5.88 (3.63)]. The cumulative amount of IPE treatment, rather than daily dosage, showed a positive correlation with changes in tissue EPA composition (Spearman's ρ = 0.23, P = 0.051). The treatment effect on tissue EPA changes appeared to be stronger for participants with lower than higher dietary EPA intake at baseline, although the interaction tests did not reach statistical significance (P for interaction = 0.26).

conclusionsIPE treatment substantially increased incorporation of marine ω-3 PUFA, particularly EPA, into the colorectal tissue while reducing tissue ω-6 PUFA composition. This trial was registered at clinicaltrials.gov as NCT04216251.

Indexed as

AdenomaColonColorectal NeoplasmsEicosapentaenoic AcidFatty Acids, Omega-3AgedDietary SupplementsFemaleHumansMaleMiddle AgedProspective StudiesEicosapentaenoic Acideicosapentaenoic acid ethyl esterFatty Acids, Omega-3colorectal adenomacolorectal cancer preventioneicosapentaenoic acidfatty acidsicosapent ethyl

Identifiers

PMID42349681
PMCPMC13444065

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