IMIBIC
Córdoba, Cordoba, 14004, Spain
Location status: Recruiting
NCT Number: NCT06015971
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
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Córdoba, Cordoba, 14004, Spain
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Take 2 omega-3 enriched oral supplements per day plus physical activity and Mediterranean Diet
Take 2 hypercaloric hyperproteic oral supplements per day plus physical activity and Mediterranean Diet
Time frame: 12 weeks
Muscle mass change (in Kg)
Time frame: 12 weeks
Changes in functionality measured with the Up and Go Test
Time frame: 12 weeks
Changes in serum albumin levels (g/dl)
Time frame: 12 weeks
Changes in serum C-RP(g/dl)
Maimónides Biomedical Research Institute of Córdoba
Other
Omega-3 Enriched Supplements in the Nutritional Support of Patients With Gastrointestinal Cancer
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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.
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