Hepatocellular CarcinomaNCT07664007

Effects of EPA Supplementation on Patients With Unresectable Hepatocellular Carcinoma.

A study testing Eicosapentaenoic acid oral lipidic emulsion and Pacebo oral lipidic emulsion in people with Hepatocellular Carcinoma, run by Instituto de Investigación Sanitaria Aragón at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Dietary intervention with eicosapentaenoic acid combined with chemotherapy may shift inflammatory mediators toward resolution in non-resectable hepatocarcinoma and help to preserve muscle mass. Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Hepatocellular Carcinoma
What is being tested?: Eicosapentaenoic acid oral lipidic emulsion and Pacebo oral lipidic emulsion
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 18 participants
Where: 1 siteSpain
Study dates: 4 Mar 2019to 20 Jun 2025
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Participants diagnosed with unresectable HCC, candidates for systemic treatment with Sorafenib or similar agents.
Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
Life expectancy > 8 weeks.
Not eligible for curative treatment (surgical resection/ablative therapy/liver transplantation).
Not having a history of previous or concomitant malignancy except when a disease-free interval > 5 years had been documented.
Not receiving any other systemic antitumor agents (docetaxel, doxorubicin, irinotecan).

Who cannot join

Allergy to omega-3 acid or fish-derived products.
Psychological or medical conditions that can interfere with study participation or the ability to provide informed consent.
Drug abuse (except for alcohol).
Any experimental therapy within 30 days prior to study entry.
Recurrent epistaxis

Trial locations and contacts

1 site in 1 country.

Spain1 site

Hospital Clínico Universitario Lozano Blesa. IIS Aragón
Zaragoza, Zaragoza, 50009

Other trials in Spain

About this study

Official title: Effects of Nutritional Supplementation With Eicosapentaenoic Acid (EPA) on Body Composition and Systemic Pro-inflammatory and Pro-resolving Mediators in Patients Diagnosed With Unresectable Hepatocellular Carcinoma.

Dietary intervention with eicosapentaenoic acid combined with chemotherapy may shift inflammatory mediators toward resolution in non-resectable hepatocarcinoma and help to preserve muscle mass.

Read the detailed description

Cancer-associated cachexia is a debilitating and potentially life-threatening syndrome characterized by progressive loss of body weight, skeletal muscle, and adipose tissue, leading to functional impairment and reduced response to oncologic therapy. It is driven in part by systemic inflammation and increased pro-inflammatory cytokines, and it cannot always be reversed with conventional support.

Eicosapentaenoic acid (EPA), an omega-3 polyunsaturated fatty acid (PUFA), has anti-inflammatory properties and is rapidly incorporated into cell membranes, modulating lipid mediator pathways. EPA supplementation may help to attenuate systemic inflammation, alleviate cachexia symptoms, and promote the production of specialized pro-resolving mediators. A daily dose of 3 grams appears sufficient to achieve maximal incorporation into cell membranes without significant adverse events.

Hepatocellular carcinoma (HCC) is one of the leading causes of cancer-related mortality worldwide, with most patients diagnosed at advanced stages. Cachexia is common in advanced HCC and contributes to functional decline, increased treatment toxicity, and poorer outcomes. Preclinical studies suggest that omega-3 PUFAs may also exert anti-tumor effects through modulation of COX-2 and Wnt/beta-catenin signaling pathways.

For these reasons, in this proposal, the investigators aim to determine wheter supplementation with EPA in combination with chemotherapy will modify the blood profile of pro-inflammatory and pro-resolving mediators, promoting the resolution of inflammation associated with HCC, and, in turn, mitigate muscle mass loss during oncologic treatment.

Conditions: Hepatocellular Carcinoma
Being tested: Eicosapentaenoic acid oral lipidic emulsion, Pacebo oral lipidic emulsion
Keywords: inflammation, cachexia, eicosapentaenoic acid, lipid mediator
Medical subject headings: Carcinoma, Hepatocellular, Inflammation, Cachexia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Eicosapentaenoic acid oral lipidic emulsionDietary supplement
1 sachet/day of 20 ml containing 3g EPA during 12 weeks
Pacebo oral lipidic emulsionDietary supplement
1 sachet/day of 20 ml of placebo during 12 weeks

Study groups in NCT07664007
Study group	Role	What they receive
Intervention group	Experimental	Patients with unresectable hepatocellular carcinoma (HCC) were given 3 grams/day of an oral lipidic emulsion of eicosapentaenoic acid in addition to their oncologic care during 12 weeks. Receives: Dietary Supplement: Eicosapentaenoic acid oral lipidic emulsion
Control group	Placebo comparator	Patients with unresectable hepatocellular carcinoma (HCC) were given a placebo oral lipidic emulsion in addition to their oncologic care during 12 weeks. Receives: Dietary Supplement: Pacebo oral lipidic emulsion

What is being measured

The primary outcome is the main question the study is designed to answer.

Effect of EPA supplementation on muscle mass
Muscle mass is assessed by calculating the skeletal muscle index using computed tomography, based on a single axial slice at the L3 level. The SliceOmatic software (TomoVision) is used for the calculations. Sarcopenia is evaluated using two criteria: Carey reference values for end-stage liver disease patients awaiting transplantation, and Martin reference values for oncology patients.
Measured: At baseline, and at 12 weeks (study completion)

Secondary outcomes (9)

Evolution of nutritional status.
Nutritional status is assessed using the validated Patient-Generated Subjective Global Assessment tool (PG-SGA, Bauer 2002) that classify patients as well nourished (A), moderately malnourished or at risk of malnutrition (B), or severely malnourished (C).
Measured: At baseline, at 6 weeks, and at 12 weeks (study completion)
Effect of EPA supplementation on quality of life assessed using the EORTC-QLQ-30.
Quality of life is assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-30)
Measured: At baseline, at 6 weeks, and at 12 weeks (study completion)
Change in the quality of life assessed using the EORTC-QLQ-HCC18.
Quality of life is assessed using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Hepatocellular Carcinoma 18-question module (QLQ-HCC18).
Measured: At baseline, at 6 weeks, and at 12 weeks (study completion)
Effect of EPA supplementation on plasma and serum profiles of pro-inflammatory and pro-resolving lipid mediators.
Plasma and serum concentrations of pro-inflammatory and pro-resolving lipid mediators derived from polyunsaturated fatty acids are determined using targeted LC-MS/MS.
Measured: At baseline, and at 12 weeks (study completion)
Change in C-reactive protein (CRP) concentration upon supplementation.
The C-reactive protein is measured using an immunoturbidimetric assay following the standard laboratory methods in the Hospital Clínico Universitario Lozano Blesa.
Measured: At baseline, and at 12 weeks (study completion)
Change in interleukin 6 upon supplementation.
Plasma IL-6 levels are determined by enzyme-linked immunosorbent assay.
Measured: At baseline, and at 12 weeks (study completion)
Change in interleukin 8 upon supplementation.
Plasma Il-8 is quantified using the Human XL Cytokine Luminex® Kit Performance Assay (R\&D Systems).
Measured: At baseline, and at 12 weeks (study completion)
Change in interferon gamma (IFNγ) upon supplementation.
Plasma IFNγ is quantified using the Human XL Cytokine Luminex® Kit Performance Assay (R\&D Systems).
Measured: At baseline, and at 12 weeks (study completion)
Change in the neutrophil-to-lymphocyte ratio (NLR) upon supplementation.
NLR is calculated by dividing the absolute neutrophil count by the absolute lymphocyte count obtained from peripheral blood samples. Both values were derived from the complete blood count (CBC) analysis.
Measured: At baseline, and at 12 weeks (study completion)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

4 Mar 201920 Jun 2025

First posted23 Jun 2026
Study start4 Mar 2019
Primary completion17 Sep 2023
Study completion20 Jun 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (12)Papers the sponsor has linked to this study.
Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 18 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07664007
Sponsor's protocol ID: LMP225_18
Status last verified: Jun 2026
First submitted: 8 May 2026
Last updated: 23 Jun 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Blazeby JM, Currie E, Zee BC, Chie WC, Poon RT, Garden OJ; EORTC Quality of Life Group. Development of a questionnaire module to supplement the EORTC QLQ-C30 to assess quality of life in patients with hepatocellular carcinoma, the EORTC QLQ-HCC18. Eur J Cancer. 2004 Nov;40(16):2439-44. doi: 10.1016/j.ejca.2004.06.033.
PubMed 15519517
Bauer J, Capra S, Ferguson M. Use of the scored Patient-Generated Subjective Global Assessment (PG-SGA) as a nutrition assessment tool in patients with cancer. Eur J Clin Nutr. 2002 Aug;56(8):779-85. doi: 10.1038/sj.ejcn.1601412.
PubMed 12122555
Martin L, Birdsell L, Macdonald N, Reiman T, Clandinin MT, McCargar LJ, Murphy R, Ghosh S, Sawyer MB, Baracos VE. Cancer cachexia in the age of obesity: skeletal muscle depletion is a powerful prognostic factor, independent of body mass index. J Clin Oncol. 2013 Apr 20;31(12):1539-47. doi: 10.1200/JCO.2012.45.2722. Epub 2013 Mar 25.
PubMed 23530101
Carey EJ, Lai JC, Wang CW, Dasarathy S, Lobach I, Montano-Loza AJ, Dunn MA; Fitness, Life Enhancement, and Exercise in Liver Transplantation Consortium. A multicenter study to define sarcopenia in patients with end-stage liver disease. Liver Transpl. 2017 May;23(5):625-633. doi: 10.1002/lt.24750.
PubMed 28240805
Lim K, Han C, Dai Y, Shen M, Wu T. Omega-3 polyunsaturated fatty acids inhibit hepatocellular carcinoma cell growth through blocking beta-catenin and cyclooxygenase-2. Mol Cancer Ther. 2009 Nov;8(11):3046-55. doi: 10.1158/1535-7163.MCT-09-0551. Epub 2009 Nov 3.
PubMed 19887546
Ikeda T, Tozuka S, Hasumura Y, Takeuchi J. Prostaglandin-E-producing hepatocellular carcinoma with hypercalcemia. Cancer. 1988 May 1;61(9):1813-4. doi: 10.1002/1097-0142(19880501)61:93.0.co;2-u.
PubMed 2833340
Onesti JK, Guttridge DC. Inflammation based regulation of cancer cachexia. Biomed Res Int. 2014;2014:168407. doi: 10.1155/2014/168407. Epub 2014 May 4.
PubMed 24877061
Ozola Zalite I, Zykus R, Francisco Gonzalez M, Saygili F, Pukitis A, Gaujoux S, Charnley RM, Lyadov V. Influence of cachexia and sarcopenia on survival in pancreatic ductal adenocarcinoma: a systematic review. Pancreatology. 2015 Jan-Feb;15(1):19-24. doi: 10.1016/j.pan.2014.11.006. Epub 2014 Dec 4.
PubMed 25524484
Dewys WD, Begg C, Lavin PT, Band PR, Bennett JM, Bertino JR, Cohen MH, Douglass HO Jr, Engstrom PF, Ezdinli EZ, Horton J, Johnson GJ, Moertel CG, Oken MM, Perlia C, Rosenbaum C, Silverstein MN, Skeel RT, Sponzo RW, Tormey DC. Prognostic effect of weight loss prior to chemotherapy in cancer patients. Eastern Cooperative Oncology Group. Am J Med. 1980 Oct;69(4):491-7. doi: 10.1016/s0149-2918(05)80001-3.
PubMed 7424938
Aoyagi T, Terracina KP, Raza A, Matsubara H, Takabe K. Cancer cachexia, mechanism and treatment. World J Gastrointest Oncol. 2015 Apr 15;7(4):17-29. doi: 10.4251/wjgo.v7.i4.17.
PubMed 25897346
Tazi E, Errihani H. Treatment of cachexia in oncology. Indian J Palliat Care. 2010 Sep;16(3):129-37. doi: 10.4103/0973-1075.73644.
PubMed 21218002
Fearon KC, Voss AC, Hustead DS; Cancer Cachexia Study Group. Definition of cancer cachexia: effect of weight loss, reduced food intake, and systemic inflammation on functional status and prognosis. Am J Clin Nutr. 2006 Jun;83(6):1345-50. doi: 10.1093/ajcn/83.6.1345.
PubMed 16762946

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Hepatocellular Carcinoma trials

Study at a glance

From the registry record, last updated by the sponsor on 23 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effects of Nutritional Supplementation With Eicosapentaenoic Acid (EPA) on Body Composition and Systemic Pro-inflammatory and Pro-resolving Mediators in Patients Diagnosed With Unresectable Hepatocellular Carcinoma.
ClinicalTrials.gov ID: NCT07664007
Acronym / sponsor ID: LMP225_18
Conditions: Hepatocellular Carcinoma
Keywords: inflammation, cachexia, eicosapentaenoic acid, lipid mediator
Study type: Interventional
Recruitment status: Completed
Enrolment: 18 participants (actual)
Lead sponsor: Instituto de Investigación Sanitaria AragónUniversity, hospital or other
Collaborators: Hospital Clínico Universitario Lozano Blesa, Solutex GC S.L.
Study start: 4 Mar 2019 (actual)
Primary completion: 17 Sep 2023 (actual)
Study completion: 20 Jun 2025 (actual)
First posted: 23 Jun 2026 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Dietary intervention with eicosapentaenoic acid combined with chemotherapy may shift inflammatory mediators toward resolution in non-resectable hepatocarcinoma and help to preserve muscle mass.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 2

Arm	Type	Receives
Intervention group	Experimental	Dietary Supplement: Eicosapentaenoic acid oral lipidic emulsionPatients with unresectable hepatocellular carcinoma (HCC) were given 3 grams/day of an oral lipidic emulsion of eicosapentaenoic acid in addition to their oncologic care during 12 weeks.
Control group	Placebo comparator	Dietary Supplement: Pacebo oral lipidic emulsionPatients with unresectable hepatocellular carcinoma (HCC) were given a placebo oral lipidic emulsion in addition to their oncologic care during 12 weeks.

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Participants diagnosed with unresectable HCC, candidates for systemic treatment with Sorafenib or similar agents.
Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
Life expectancy > 8 weeks.
Not eligible for curative treatment (surgical resection/ablative therapy/liver transplantation).
Not having a history of previous or concomitant malignancy except when a disease-free interval > 5 years had been documented.

Key exclusion criteria (5 listed)

Allergy to omega-3 acid or fish-derived products.
Psychological or medical conditions that can interfere with study participation or the ability to provide informed consent.
Drug abuse (except for alcohol).
Any experimental therapy within 30 days prior to study entry.
Recurrent epistaxis

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Eicosapentaenoic acid oral lipidic emulsion1 sachet/day of 20 ml containing 3g EPA during 12 weeks	Dietary supplement	Intervention group
Pacebo oral lipidic emulsion1 sachet/day of 20 ml of placebo during 12 weeks	Dietary supplement	Control group

Primary outcome

Effect of EPA supplementation on muscle mass
Time frame: At baseline, and at 12 weeks (study completion)
Muscle mass is assessed by calculating the skeletal muscle index using computed tomography, based on a single axial slice at the L3 level. The SliceOmatic software (TomoVision) is used for the calculations. Sarcopenia is evaluated using two criteria: Carey reference values for end-stage liver disease patients awaiting transplantation, and Martin reference values for oncology patients.

9 secondary outcomes

Evolution of nutritional status.
Time frame: At baseline, at 6 weeks, and at 12 weeks (study completion)
Effect of EPA supplementation on quality of life assessed using the EORTC-QLQ-30.
Time frame: At baseline, at 6 weeks, and at 12 weeks (study completion)
Change in the quality of life assessed using the EORTC-QLQ-HCC18.
Time frame: At baseline, at 6 weeks, and at 12 weeks (study completion)
Effect of EPA supplementation on plasma and serum profiles of pro-inflammatory and pro-resolving lipid mediators.
Time frame: At baseline, and at 12 weeks (study completion)
Change in C-reactive protein (CRP) concentration upon supplementation.
Time frame: At baseline, and at 12 weeks (study completion)
Change in interleukin 6 upon supplementation.
Time frame: At baseline, and at 12 weeks (study completion)
Change in interleukin 8 upon supplementation.
Time frame: At baseline, and at 12 weeks (study completion)
Change in interferon gamma (IFNγ) upon supplementation.
Time frame: At baseline, and at 12 weeks (study completion)
Change in the neutrophil-to-lymphocyte ratio (NLR) upon supplementation.
Time frame: At baseline, and at 12 weeks (study completion)

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2026.
Background: PubMed 15519517Blazeby JM, Currie E, Zee BC, Chie WC, Poon RT, Garden OJ; EORTC Quality of Life Group. Development of a questionnaire module to supplement the EORTC QLQ-C30 to assess quality of life in patients with hepatocellular carcinoma, the EORTC QLQ-HCC18. Eur J Cancer. 2004 Nov;40(16):2439-44. doi: 10.1016/j.ejca.2004.06.033.
Background: PubMed 12122555Bauer J, Capra S, Ferguson M. Use of the scored Patient-Generated Subjective Global Assessment (PG-SGA) as a nutrition assessment tool in patients with cancer. Eur J Clin Nutr. 2002 Aug;56(8):779-85. doi: 10.1038/sj.ejcn.1601412.
Background: PubMed 23530101Martin L, Birdsell L, Macdonald N, Reiman T, Clandinin MT, McCargar LJ, Murphy R, Ghosh S, Sawyer MB, Baracos VE. Cancer cachexia in the age of obesity: skeletal muscle depletion is a powerful prognostic factor, independent of body mass index. J Clin Oncol. 2013 Apr 20;31(12):1539-47. doi: 10.1200/JCO.2012.45.2722. Epub 2013 Mar 25.
Background: PubMed 28240805Carey EJ, Lai JC, Wang CW, Dasarathy S, Lobach I, Montano-Loza AJ, Dunn MA; Fitness, Life Enhancement, and Exercise in Liver Transplantation Consortium. A multicenter study to define sarcopenia in patients with end-stage liver disease. Liver Transpl. 2017 May;23(5):625-633. doi: 10.1002/lt.24750.
Background: PubMed 19887546Lim K, Han C, Dai Y, Shen M, Wu T. Omega-3 polyunsaturated fatty acids inhibit hepatocellular carcinoma cell growth through blocking beta-catenin and cyclooxygenase-2. Mol Cancer Ther. 2009 Nov;8(11):3046-55. doi: 10.1158/1535-7163.MCT-09-0551. Epub 2009 Nov 3.
Background: PubMed 2833340Ikeda T, Tozuka S, Hasumura Y, Takeuchi J. Prostaglandin-E-producing hepatocellular carcinoma with hypercalcemia. Cancer. 1988 May 1;61(9):1813-4. doi: 10.1002/1097-0142(19880501)61:93.0.co;2-u.
Background: PubMed 24877061Onesti JK, Guttridge DC. Inflammation based regulation of cancer cachexia. Biomed Res Int. 2014;2014:168407. doi: 10.1155/2014/168407. Epub 2014 May 4.
Background: PubMed 25524484Ozola Zalite I, Zykus R, Francisco Gonzalez M, Saygili F, Pukitis A, Gaujoux S, Charnley RM, Lyadov V. Influence of cachexia and sarcopenia on survival in pancreatic ductal adenocarcinoma: a systematic review. Pancreatology. 2015 Jan-Feb;15(1):19-24. doi: 10.1016/j.pan.2014.11.006. Epub 2014 Dec 4.
Background: PubMed 7424938Dewys WD, Begg C, Lavin PT, Band PR, Bennett JM, Bertino JR, Cohen MH, Douglass HO Jr, Engstrom PF, Ezdinli EZ, Horton J, Johnson GJ, Moertel CG, Oken MM, Perlia C, Rosenbaum C, Silverstein MN, Skeel RT, Sponzo RW, Tormey DC. Prognostic effect of weight loss prior to chemotherapy in cancer patients. Eastern Cooperative Oncology Group. Am J Med. 1980 Oct;69(4):491-7. doi: 10.1016/s0149-2918(05)80001-3.
Background: PubMed 25897346Aoyagi T, Terracina KP, Raza A, Matsubara H, Takabe K. Cancer cachexia, mechanism and treatment. World J Gastrointest Oncol. 2015 Apr 15;7(4):17-29. doi: 10.4251/wjgo.v7.i4.17.
Background: PubMed 21218002Tazi E, Errihani H. Treatment of cachexia in oncology. Indian J Palliat Care. 2010 Sep;16(3):129-37. doi: 10.4103/0973-1075.73644.
Background: PubMed 16762946Fearon KC, Voss AC, Hustead DS; Cancer Cachexia Study Group. Definition of cancer cachexia: effect of weight loss, reduced food intake, and systemic inflammation on functional status and prognosis. Am J Clin Nutr. 2006 Jun;83(6):1345-50. doi: 10.1093/ajcn/83.6.1345.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Angel Lanas Arbeloa, MD, PhD principal investigator

University Hospital Lozano Blesa. IIS Aragón. CIBER de Enfermedades Hepáticas y Digestivas

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Effect of EPA supplementation on muscle mass (time frame: At baseline, and at 12 weeks (study completion)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07664007, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2026.