Skip to main content
OpenTrials
Completed

NCT Number: NCT05495360

Effect of Omega 3 Enriched Oral Nutritional Supplement on Nutritional Status of CRC and NSCLC Patients

A single arm intervention study examining the effect of an omega 3 enriched oral nutritional supplement on nutritional status of CRC and NSCLC patients

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universitair Ziekenhuis Brussel, Brussels, Belgium

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Histologically proven CRC or histologically or cytologically proven NSCLC
  • Eligible and scheduled for at least 2 cycles of 4-week cycles of systemic treatment, 3 cycles of 3-week cycles of systemic treatment or 4 cycles of 2-week cycles of systemic treatment
  • At risk of malnutrition or malnourished [PG-SGA-SF > 4]
  • Performance status ECOG 0 or 1
  • Weight loss grade 0-3 according to Martin et al1
  • <11% weight loss in the past 6 months
  • Age ≥ 18 years
  • Written informed consent

Exclusion criteria

  • Presence of ileostoma or ileal pouch
  • GI-related or major surgery in 30 days prior to baseline
  • Severe hypercalcemia, i.e. total calcium level, corrected for albumin ≥ 14.0 mg/dL (3.5 mmol/L)
  • Use of ONS, enteral nutrition or parenteral nutrition within 14 days prior to entry into the study
  • Use of fish oil containing supplements, within 30 days prior to entry into the study or expected to use this during the study
  • Use of more than 200 iU/day of vitamin D containing supplements within 30 days prior to entry into the study or expected to use this during the study
  • Life expectancy of < 3 months
  • Severe renal dysfunction (<29 ml/min/1.73m2 eGRF or albumin:creatinine (ACR) > 30) or hepatic encephalopathy
  • Allergy to cow's milk protein or fish, known protein sensitivity or suffering galactosemia
  • Known pregnancy or lactation
  • Current alcohol or drug abuse in opinion of the investigator
  • Investigator's uncertainty about the willingness or ability of the patient to comply with the protocol requirements
  • Participation in any other studies involving investigational or marketed products concomitantly or within two weeks prior to entry into the study

Treatment and study plan

Oral Nutritional Supplement

Dietary Supplement

twice daily serving of the study product

Primary outcomes

  1. Change in EPA concentration in the phospholipid fraction of the erythrocyte membrane [% of total fatty acids]

    Time frame: at end of first in-study treatment cycle compared to baseline

Secondary outcomes

  1. Change in protein intake [g/day] [key secondary outcome)

    Time frame: at end of first in-study treatment cycle compared to baseline

  2. Change in protein intake [g/kg bw/day] [key secondary outcome)

    Time frame: at end of first in-study treatment cycle compared to baseline

  3. Change in energy intake [kcal/day]

    Time frame: at end of first in-study treatment cycle compared to baseline

  4. Change in energy intake [kcal/kg bw/day]

    Time frame: at end of first in-study treatment cycle compared to baseline

  5. Provided vitamin D supplementation [µg/day] by the test product

    Time frame: Throughout total intervention period - about 2 months

  6. Change in fatty acid profile in the phospholipid fraction of the cell membrane of erythrocytes [% of total fatty acids]

    Time frame: at end of first in-study treatment cycle compared to baseline

Sponsors and collaborators

Lead sponsor

Nutricia Research

Industry

Registry information

Acronym: OMENS

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Aug 10, 2022
Registry last updated
Feb 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.