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

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

Study Overview

• Status: Completed
• Conditions: Malnutrition; Oncology
• Intervention / Treatment: Dietary supplement: Oral Nutritional Supplement

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm 1; twice daily serving of the study product	Dietary supplement: Oral Nutritional Supplement; twice daily serving of the study product

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in EPA concentration in the phospholipid fraction of the erythrocyte membrane [% of total fatty acids]	at end of first in-study treatment cycle compared to baseline

Secondary Outcome Measures

Outcome Measure	Time Frame
Change in protein intake [g/day] [key secondary outcome)	at end of first in-study treatment cycle compared to baseline
Change in protein intake [g/kg bw/day] [key secondary outcome)	at end of first in-study treatment cycle compared to baseline
Change in energy intake [kcal/day]	at end of first in-study treatment cycle compared to baseline
Change in energy intake [kcal/kg bw/day]	at end of first in-study treatment cycle compared to baseline
Provided vitamin D supplementation [µg/day] by the test product	Throughout total intervention period - about 2 months
Change in fatty acid profile in the phospholipid fraction of the cell membrane of erythrocytes [% of total fatty acids]	at end of first in-study treatment cycle compared to baseline

Collaborators and Investigators

• Sponsor: Nutricia Research

Study record dates

Study Major Dates

• Study Start (Actual): January 17, 2023
• Primary Completion (Actual): September 2, 2024
• Study Completion (Actual): September 2, 2024

Study Registration Dates

• First Submitted: August 2, 2022
• First Submitted That Met QC Criteria: August 8, 2022
• First Posted (Actual): August 10, 2022

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 14, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: Oncology; Omega 3; Oral nutritional supplement
• Additional Relevant MeSH Terms: Nutrition Disorders; Malnutrition
• Other Study ID Numbers: SBB20R&35115

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No