MalnutritionOMENSNCT05495360
Effect of Omega 3 Enriched Oral Nutritional Supplement on Nutritional Status of CRC and NSCLC Patients
A study testing Oral Nutritional Supplement in people with Malnutrition and Oncology, run by Nutricia Research at 5 sites in 3 countries.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malnutrition, Oncology
- What is being tested?
- Oral Nutritional Supplement
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 5 sitesin 3 countries
- Study dates
- 17 Jan 2023to 2 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
5 sites in 3 countries.
5 sites in 3 countries
About this study
A single arm intervention study examining the effect of an omega 3 enriched oral nutritional supplement on nutritional status of CRC and NSCLC patients
- Conditions
- Malnutrition, Oncology
- Being tested
- Oral Nutritional Supplement
- Keywords
- Oral nutritional supplement, Oncology, Omega 3
- Medical subject headings
- Malnutrition, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral Nutritional SupplementDietary supplement
twice daily serving of the study product
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | twice daily serving of the study product Receives: Dietary Supplement: Oral Nutritional Supplement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in EPA concentration in the phospholipid fraction of the erythrocyte membrane [% of total fatty acids]
Measured: at end of first in-study treatment cycle compared to baseline
Secondary outcomes (6)
Change in protein intake [g/day] [key secondary outcome)
Measured: at end of first in-study treatment cycle compared to baseline
Change in protein intake [g/kg bw/day] [key secondary outcome)
Measured: at end of first in-study treatment cycle compared to baseline
Change in energy intake [kcal/day]
Measured: at end of first in-study treatment cycle compared to baseline
Change in energy intake [kcal/kg bw/day]
Measured: at end of first in-study treatment cycle compared to baseline
Provided vitamin D supplementation [µg/day] by the test product
Measured: 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]
Measured: at end of first in-study treatment cycle compared to baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2022
- Study start17 Jan 2023
- Primary completion2 Sep 2024
- Study completion2 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MalnutritionStudies of the same condition, open and under way.
- More trials run by Nutricia ResearchThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nutricia Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05495360
- Sponsor's protocol ID
- SBB20R&35115
- Acronym
- OMENS
- Status last verified
- Feb 2025
- First submitted
- 2 Aug 2022
- Last updated
- 19 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Omega 3 Enriched Oral Nutritional Supplement on Nutritional Status of CRC and NSCLC Patients
- ClinicalTrials.gov ID
- NCT05495360
- Acronym / sponsor ID
- OMENS / SBB20R&35115
- Conditions
- Malnutrition, Oncology
- Keywords
- Oral nutritional supplement, Oncology, Omega 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Nutricia ResearchIndustry (pharma, biotech, devices)
- Study start
- 17 Jan 2023 (actual)
- Primary completion
- 2 Sep 2024 (actual)
- Study completion
- 2 Sep 2024 (actual)
- First posted
- 10 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Dietary Supplement: Oral Nutritional Supplementtwice daily serving of the study product |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oral Nutritional Supplementtwice daily serving of the study product | Dietary supplement | Arm 1 |
Primary outcome
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
6 secondary outcomes
Change in protein intake [g/day] [key secondary outcome)
Time frame: at end of first in-study treatment cycle compared to baseline
Change in protein intake [g/kg bw/day] [key secondary outcome)
Time frame: at end of first in-study treatment cycle compared to baseline
Change in energy intake [kcal/day]
Time frame: at end of first in-study treatment cycle compared to baseline
Change in energy intake [kcal/kg bw/day]
Time frame: at end of first in-study treatment cycle compared to baseline
Provided vitamin D supplementation [µg/day] by the test product
Time frame: 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]
Time frame: at end of first in-study treatment cycle compared to baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2025.
- Individual participant dataSharing planned: No
Related trials for Malnutrition
RecruitingPhase 1/2
A First-in-human Study of KK8123 in Adults With X-linked Hypophosphatemia
X-linked Hypophosphatemia
Recruiting
Linking Education, Produce Provision, and Community Referrals to Improve Diabetes Care (LINK)
Diabetes Mellitus, Type 2, Nutrition Poor
Active, not recruiting
Evaluation of Personalized Nutritional Intervention on Wound Healing of Cutaneous Ulcers in Diabetics
Foot, Diabetic
Active, not recruitingPhase 2
Maternal Probiotic Intervention to Improve Gut Health-Trial II-Pakistan
Environmental Enteric Dysfunction (EED), Stunting
Not yet recruitingObservational study
Biomarkers in EV Associated With Marrow Adiposity in Anorexia
Anorexia Nervosa Restricting Type, Anorexia Nervosa (DSM-IV Revised Criteria)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oral Nutritional Supplement in people with Malnutrition and Oncology, run by Nutricia Research at 5 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Belgium, Czechia, Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2025.