Optimizing Patient Treatment With EPA-enriched Nutrition, a Randomised Control Trial

Sponsor
University of Edinburgh
Study ID
NCT07255066
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Fortimel Forticare Sensations — DIETARY_SUPPLEMENT
    An EPA-enriched experimental Oral Nutritional Supplement

Study Details

Malnutrition is a common and serious issue for people living with cancer. Many cancer patients experience weight loss, muscle weakness, and poor quality of life due to malnutrition. This can also reduce the success of cancer treatments, increase hospital visits, and add emotional distress for both patients and their loved ones. 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.

Key Dates

First listed
Nov 28, 2025
Start date
Jun 30, 2026
Status verified
May 2026
Primary completion
Jan 31, 2027
Completion
Jun 30, 2027

Study Design

Enrollment
118 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Dietary Counselling and EPA-enriched FFS (experimental ONS) and standard care
  • No Intervention: Dietary Counselling and standard care

Primary Outcome Measure

Body Weight - light clothes, no shoes [ Time Frame: From baseline to day 56 ]

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