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CompletedNCT05495360OMENSUpdated Feb 19, 2025

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

An interventional study of Oral Nutritional Supplement in Malnutrition and Oncology, sponsored by Nutricia Research. Completed at 5 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-02-19.

Sponsored by Nutricia Research · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
48
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

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

02

Conditions studied

  • Malnutrition
  • Oncology

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Keywords

  • Oral nutritional supplement
  • Oncology
  • Omega 3
03

In context

Malnutrition

1,587 studies on the registry are indexed under Malnutrition; 237 are open to participants now.

This study's enrollment of 48 is below the median of 90 across 1,134 interventional studies indexed under Malnutrition.

Browse Malnutrition studies →

Lead sponsor

Nutricia Research is the lead sponsor of 48 studies on the registry; 12 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Histologically proven CRC or histologically or cytologically proven NSCLC
  2. 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
  3. At risk of malnutrition or malnourished [PG-SGA-SF > 4]
  4. Performance status ECOG 0 or 1
  5. Weight loss grade 0-3 according to Martin et al1
  6. \<11% weight loss in the past 6 months
  7. Age ≥ 18 years
  8. Written informed consent

Exclusion criteria

Exclusion Criteria:

  1. Presence of ileostoma or ileal pouch
  2. GI-related or major surgery in 30 days prior to baseline
  3. Severe hypercalcemia, i.e. total calcium level, corrected for albumin ≥ 14.0 mg/dL (3.5 mmol/L)
  4. Use of ONS, enteral nutrition or parenteral nutrition within 14 days prior to entry into the study
  5. Use of fish oil containing supplements, within 30 days prior to entry into the study or expected to use this during the study
  6. 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
  7. Life expectancy of \< 3 months
  8. Severe renal dysfunction (\<29 ml/min/1.73m2 eGRF or albumin:creatinine (ACR) > 30) or hepatic encephalopathy
  9. Allergy to cow's milk protein or fish, known protein sensitivity or suffering galactosemia
  10. Known pregnancy or lactation
  11. Current alcohol or drug abuse in opinion of the investigator
  12. Investigator's uncertainty about the willingness or ability of the patient to comply with the protocol requirements
  13. Participation in any other studies involving investigational or marketed products concomitantly or within two weeks prior to entry into the study
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
48 participants (actual)

Study arms

  • Experimental
    Arm 1

    twice daily serving of the study product

    Dietary Supplement: Oral Nutritional Supplement

Interventions

  • Dietary supplementOral Nutritional Supplement

    twice daily serving of the study product

06

What researchers measure

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

07

Study locations

5 sites
  • Universitair Ziekenhuis Brussel
    Brussels, Belgium
  • AZ Delta
    Roeselare, Belgium
  • Faculty Hospital Brno
    Brno, Czechia
  • Fakultní nemocnice Bulovka
    Praha, Czechia
  • Cork University Hospital
    Cork, Ireland
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 19, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05495360
Lead sponsor
Nutricia Research
Responsible party
Sponsor
First posted
Aug 10, 2022
Start date
Jan 17, 2023
Primary completion
Sep 2, 2024
Completion
Sep 2, 2024
Last update
Feb 19, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.

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