Optimizing Patient Treatment With EPA-enriched Nutrition, a Randomised Control Trial
NCT ID: NCT07255066
Last Updated: 2025-12-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
NOT_YET_RECRUITING
NA
118 participants
INTERVENTIONAL
2025-12-31
2027-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Treating malnutrition through good nutritional care is increasingly recognised as an important part of cancer treatment. Leading experts recommend that all cancer patients be checked for signs of malnutrition and given personalised nutrition plans when necessary. While dietary counselling and oral nutritional supplements (ONS) are often used to help patients, there is still a need for better evidence to show how well these interventions work.
A key factor contributing to malnutrition in cancer patients is inflammation. Omega-3 fatty acids, (like those found in oily fish) are known for their anti-inflammatory properties. Some studies suggest that omega-3s may help cancer patients by reducing inflammation, keeping muscles strong, improving appetite, and enhancing overall well-being.
The OPT-EPA study will investigate whether a nutritional drink, called Fortimel Forticare Sensations (FFS), can improve nutritional status in patients with lung or colorectal cancer who are at risk of malnutrition. This drink is enriched with omega-3 fatty acids (Eicosapentanoic acid (EPA) and Docosahexaenoic acid (DHA)) and provides a high amount of protein and calories in a small volume, making it easier to consume, especially for patients with taste changes.
In this study, participants will be divided into two groups. The experimental group will receive dietary counselling and standard care along with FFS, the omega-3-enriched nutritional drink, while the other (control) group will receive dietary counselling and standard care, with supplements provided only if clinically necessary. Researchers will evaluate the impact on patients' nutritional status, body weight, muscle, inflammation levels, and quality of life.
Through the OPT-EPA study, researchers hope to gain clearer insights into whether omega-3-containing supplements can provide meaningful benefits for cancer patients. Ultimately, this could help improve the quality of care and outcomes for people facing cancer-related malnutrition.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Dietary Counselling and EPA-enriched FFS (experimental ONS) and standard care
Fortimel Forticare Sensations
An EPA-enriched experimental Oral Nutritional Supplement
Dietary Counselling and standard care
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Fortimel Forticare Sensations
An EPA-enriched experimental Oral Nutritional Supplement
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Participants aged 18 or older
* Participants at nutritional risk defined as a BMI \<20 kg/m2 and/or weight loss between 5-10% in the previous 6 months\*\*
* Participants with systemic inflammation within 28 days of screening (e.g. CRP \>10 mg/dL)
* Participants with an ECOG-PS\*\*\* score of 0, 1 or 2
* Participants willing and able to give written informed consent
Exclusion Criteria
* Participants who have lost \>10% body weight in the previous 6 months before baseline - observed or participant reported.
* Participants with severe renal or hepatic failure or an intolerance to any of the ingredients of the study product
* Participants who are using dietary counselling, ONS or any form of artificial feeding at the time of recruitment
* Unable to adhere to either arm of the trial and appropriate requirements
* Contraindication to ONS including a lactose intolerance
* Females who are pregnant or of childbearing potential and not using adequate contraception
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of Southampton
OTHER
Danone Global Research & Innovation Center
INDUSTRY
University of Edinburgh
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2024-07601
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
AC25085
Identifier Type: -
Identifier Source: org_study_id