SarcopeniaNCT06015971
Omega-3 Fatty Acids and Nutritional Support in Gastrointestinal Cancer
A study testing omega-3 and Standard in people with Sarcopenia, run by Maimónides Biomedical Research Institute of Córdoba at 1 site in Spain.
Trial summary
Sarcopenia is a frequent complication in patients with cancer and chronic diseases, it is characterized by decreased muscle strength and fatigue due to reduced skeletal muscle mass, which is accompanied by atrophy and decreased quality of muscle tissue. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sarcopenia
- What is being tested?
- omega-3 and Standard
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jul 2023to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- - Patients with Gastrointestinal tumor undergoing systemic treatment (chemo-radio-immuno therapy or their combination)
- Body weight loss >5% in the previous three months or >10% in the previous six months
- Both sexes
- Age between 18-85 y-old.
Who cannot join
- Life expectancy < 2 weeks
- MDRD < 15 mL/min
- End-stage liver disease
- Any musculoskeletal, cardiovascular and/or neurological disorders that could affect exercising.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
IMIBIC
Córdoba, Cordoba, 14004
Jose Carlos Garrido, PhD, 957 213831, josecarlos.garrido@imibic.org
About this study
Official title: Omega-3 Enriched Supplements in the Nutritional Support of Patients With Gastrointestinal Cancer
Sarcopenia is a frequent complication in patients with cancer and chronic diseases, it is characterized by decreased muscle strength and fatigue due to reduced skeletal muscle mass, which is accompanied by atrophy and decreased quality of muscle tissue. In all cases, it negatively impacts treatment tolerance, clinical outcomes and survival, in consequence, quality of life of these patients decreases while morbidity, mortality and costs increase. In this context, appropriate nutritional screening and early nutrition support are extremely recommended, to this aim, in some cases, oral nutritional supplements (ONS) are necessary; ONS could have a standard formula or be enriched with specific nutrients (arginine, glutamine, branched chain amino acids, n-3 fatty acids, and nucleotides), which can modulate the activity of the immune system and provide an additional benefit beyond the nutritional support, this intervention type is called immunonutrition. Despite these possible benefits, their utility has been proven in few clinical scenarios, for example in with patients with upper gastrointestinal cancer undergoing surgical resection; based on this, current guidelines recommend that patients should receive oral/enteral nutritional support with an specific formula enriched in immunonutrients (with arginine, n-3 fatty acids or nucleotides) , but there is a lack of evidence for supporting its use in other clinical conditions including patients with cancer that receive systemic treatment
- Conditions
- Sarcopenia
- Being tested
- omega-3, Standard
- Keywords
- cancer, nutritional support, omega-3 enriched nutritional supplements
- Medical subject headings
- Sarcopenia, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
omega-3Dietary supplement
Take 2 omega-3 enriched oral supplements per day plus physical activity and Mediterranean Diet
StandardDietary supplement
Take 2 hypercaloric hyperproteic oral supplements per day plus physical activity and Mediterranean Diet
| Study group | Role | What they receive |
|---|---|---|
| standard hypercaloric, hyperproteic oral supplement | Active comparator | Not described Receives: Dietary Supplement: Standard |
| omega-3 enriched oral supplement | Experimental | Not described Receives: Dietary Supplement: omega-3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle mass
Muscle mass change (in Kg)
Measured: 12 weeks
Functionality
Changes in functionality measured with the Up and Go Test
Measured: 12 weeks
Secondary outcomes (2)
Albumin
Changes in serum albumin levels (g/dl)
Measured: 12 weeks
C-RP
Changes in serum C-RP(g/dl)
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2023
- Study start1 Jul 2023
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SarcopeniaStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maimónides Biomedical Research Institute of Córdoba
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06015971
- Sponsor's protocol ID
- Sarcopenia omega3
- Status last verified
- May 2025
- First submitted
- 23 Aug 2023
- Last updated
- 6 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Omega-3 Enriched Supplements in the Nutritional Support of Patients With Gastrointestinal Cancer
- ClinicalTrials.gov ID
- NCT06015971
- Acronym / sponsor ID
- Sarcopenia omega3
- Conditions
- Sarcopenia
- Keywords
- cancer, nutritional support, omega-3 enriched nutritional supplements
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Maimónides Biomedical Research Institute of CórdobaUniversity, hospital or other
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 29 Aug 2023 (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.
Sarcopenia is a frequent complication in patients with cancer and chronic diseases, it is characterized by decreased muscle strength and fatigue due to reduced skeletal muscle mass, which is accompanied by atrophy and decreased quality of muscle tissue. In all cases, it negatively impacts treatment tolerance, clinical outcomes and survival, in consequence, quality of life of these patients decreases while morbidity, mortality and costs increase. In this context, appropriate nutritional screening and early nutrition support are extremely recommended, to this aim, in some cases, oral nutritional supplements (ONS) are necessary; ONS could have a standard formula or be enriched with specific nutrients (arginine, glutamine, branched chain amino acids, n-3 fatty acids, and nucleotides), which can modulate the activity of the immune system and provide an additional benefit beyond the nutritional support, this intervention type is called immunonutrition. Despite these possible benefits, their utility has been proven in few clinical scenarios, for example in with patients with upper gastrointestinal cancer undergoing surgical resection; based on this, current guidelines recommend that patients should receive oral/enteral nutritional support with an specific formula enriched in immunonutrients (with arginine, n-3 fatty acids or nucleotides) , but there is a lack of evidence for supporting its use in other clinical conditions including patients with cancer that receive systemic treatment
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| standard hypercaloric, hyperproteic oral supplement | Active comparator | Dietary Supplement: Standard |
| omega-3 enriched oral supplement | Experimental | Dietary Supplement: omega-3 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- - Patients with Gastrointestinal tumor undergoing systemic treatment (chemo-radio-immuno therapy or their combination)
- Body weight loss >5% in the previous three months or >10% in the previous six months
- Both sexes
- Age between 18-85 y-old.
Key exclusion criteria (4 listed)
- Life expectancy < 2 weeks
- MDRD < 15 mL/min
- End-stage liver disease
- Any musculoskeletal, cardiovascular and/or neurological disorders that could affect exercising.
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 |
|---|---|---|
| omega-3Take 2 omega-3 enriched oral supplements per day plus physical activity and Mediterranean Diet | Dietary supplement | omega-3 enriched oral supplement |
| StandardTake 2 hypercaloric hyperproteic oral supplements per day plus physical activity and Mediterranean Diet | Dietary supplement | standard hypercaloric, hyperproteic oral supplement |
Primary outcome
Muscle mass
Time frame: 12 weeks
Muscle mass change (in Kg)
Functionality
Time frame: 12 weeks
Changes in functionality measured with the Up and Go Test
2 secondary outcomes
Albumin
Time frame: 12 weeks
C-RP
Time frame: 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2025.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing omega-3 and Standard in people with Sarcopenia, run by Maimónides Biomedical Research Institute of Córdoba at 1 site in Spain.
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 4 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 6 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Muscle mass (time frame: 12 weeks). The study lists 2 primary outcomes in all. 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 6 May 2025.