Disease-related Malnutrition, Inflammation
Conditions
Brief summary
Disease-related malnutrition (DRM) is a frequent syndrome in clinical practice, in which the mutual relationship between disease and malnutrition is observed. Inflammation, anorexia, changes in body composition or in energy and protein requirements, contribute to the development of DRM. The Global Leadership Initiative on Malnutrition (GLIM criteria) provides a diagnostic system of malnutrition that has been accepted by the main international scientific societies in the field of clinical nutrition. The GLIM criteria proposes an algorithm that includes phenotypic criteria (weight loss, underweight and low muscle mass), with their corresponding severity thresholds, and aetiological criteria (decreased oral intake, nutrient malabsorption and the presence of an inflammatory component). The diagnosis of malnutrition is established when an aetiological and a phenotypic criterion are met. The aim of the study is to determine the diagnostic and prognostic value of aetiological factors of malnutrition based on GLIM criteria, presence and degree of inflammation and dietary intake, in patients diagnosed with DRM.
Interventions
DIETARY_SUPPLEMENTOral nutritional supplement rich in omega-3 and olive oil polyphenols
Nutritional intervention with an oral nutrition supplement with anti-inflammatory effect and a programme of physical exercise
Sponsors
Adventia Pharma
Endocrinology and Clinical Nutrition Research Center, Spain
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosis of DRM based on GLIM criteria with the presence of the aetiological criterion of inflammatory component and candidate for medical nutritional treatment according to current regulations. * Agreeing to voluntarily participate in the study and sign the informed consent form, after having read the participant information sheet. * Presence of an inflammatory response (CRP\>3 mg/dl) * Having an adequate cultural level and understanding of the clinical study.
Exclusion criteria
* Pregnant or breastfeeding women * Patients with advanced liver cirrhosis or chronic hepatitis (Child=C scale) * Patients with advanced neoplastic disease with life expectancy \<6 months * Patients with renal insufficiency with creatinine clearance less than 45 ml/min * Severe infection in the last 3 weeks * Taking antibiotic therapy at the time of inclusion, with the exception of prophylactic treatments * Taking corticosteroids at the current time or one month prior to inclusion * Treatment with biological therapies (antibodies) at the current time or one month in advance * Taking non-steroidal anti-inflammatory drugs at the time of inclusion * Taking omega 3 supplements for any concomitant pathology at the time of inclusion * Undergoing surgery during the follow-up phase of the study * Initiation of any drug during the study phase that may modify the patient's inflammatory pattern at the investigator's discretion * Any criterion that, in the opinion of the principal investigator, could condition the conduct of the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Blood biochemistry data | Patients will be followed over a period of 3 consecutive months | Albumin (g/dL) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Bioelectrical impedance data (model (50 kHz) | Patients will be followed over a period of 3 consecutive months | TBW (total body water, L) |
| Functional parameters | Patients will be followed over a period of 3 consecutive months | Test up and go (patient sits in a chair and is told to stand up (time starts), walks 3 meters, comes back and sits down (time ends). \<20 seconds: OK; \>20seconds: increased risk of falling |
| Oral intake | Patients will be followed over a period of 3 consecutive months | Energy: obtained from the nutritional analysis of a two-day dietary survey using the programme https://calcdieta.ienva.org (kcal) |
| Malnutrition Diagnosis | Patients will be followed over a period of 3 consecutive months | GLIM criteria (Global Leadership Initiative on Malnutrition): GLIM rank indicates the patient's nutritional status according to 3 categories: well nourished, moderate malnutrition and severe malnutrition |
Countries
Spain
Outcome results
None listed