Analysis of the Aetiological Factors of Malnutrition

Study Overview
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Brief Summary
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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.

Official Title
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Analysis of the Aetiological Factors of Malnutrition: Inflammation and Oral Intake

Conditions
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Disease-related Malnutrition, Inflammation

Intervention / Treatment
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* Dietary Supplement: Oral nutritional supplement rich in omega-3 and olive oil polyphenols


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Dietary Supplement: Oral 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|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood biochemistry data | Albumin (g/dL) | Patients will be followed over a period of 3 consecutive months | 
| Blood biochemistry data | Prealbumin (mg/dL) | Patients will be followed over a period of 3 consecutive months | 
| Blood biochemistry data | C-reactive protein (mg/L) | Patients will be followed over a period of 3 consecutive months | 
| Blood biochemistry data | Ferritin (ng/mL) | Patients will be followed over a period of 3 consecutive months | 
| Blood biochemistry data | Neutrophils (x103/μL) | Patients will be followed over a period of 3 consecutive months | 
| Blood biochemistry data | Lymphocytes (x103/μL) | Patients will be followed over a period of 3 consecutive months | 
| Blood biochemistry data | Platelets (x103/μL) | Patients will be followed over a period of 3 consecutive months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bioelectrical impedance data (model (50 kHz) | TBW (total body water, L) | Patients will be followed over a period of 3 consecutive months | 
| Bioelectrical impedance data (model (50 kHz) | ECW (extracellular water, L) | Patients will be followed over a period of 3 consecutive months | 
| Bioelectrical impedance data (model (50 kHz) | ICW (intracellular water, L) | Patients will be followed over a period of 3 consecutive months | 
| Bioelectrical impedance data (model (50 kHz) | FFM (lean mass, kg) | Patients will be followed over a period of 3 consecutive months | 
| Bioelectrical impedance data (model (50 kHz) | FM (fat mass, kg) | Patients will be followed over a period of 3 consecutive months | 
| Bioelectrical impedance data (model (50 kHz) | BCM (body cell mass, kg) | Patients will be followed over a period of 3 consecutive months | 
| Bioelectrical impedance data (model (50 kHz) | ASMM (appendicular skeletal muscle mass, kg) | Patients will be followed over a period of 3 consecutive months | 
| Bioelectrical impedance data (model (50 kHz) | SMI (skeletal muscle mass index, kg) | Patients will be followed over a period of 3 consecutive months | 
| Functional parameters | 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 | Patients will be followed over a period of 3 consecutive months | 
| Functional parameters | Dynamometry: hree measurements of the dominant hand will be made recording the mean and maximum, measured in kilograms. Jamar® dynamometers are most used in international studies and have several grip positions | Patients will be followed over a period of 3 consecutive months | 
| Oral intake | Energy: obtained from the nutritional analysis of a two-day dietary survey using the programme https://calcdieta.ienva.org (kcal) | Patients will be followed over a period of 3 consecutive months | 
| Oral intake | Protein: obtained from the nutritional analysis of a two-day dietary survey using the programme https://calcdieta.ienva.org (g) | Patients will be followed over a period of 3 consecutive months | 
| Oral intake | Carbohydrate: obtained from the nutritional analysis of a two-day dietary survey using the programme https://calcdieta.ienva.org (g) | Patients will be followed over a period of 3 consecutive months | 
| Oral intake | Fat: obtained from the nutritional analysis of a two-day dietary survey using the programme https://calcdieta.ienva.org (g) | Patients will be followed over a period of 3 consecutive months | 
| Oral intake | MUFA (monounsaturated fat acids): obtained from the nutritional analysis of a two-day dietary survey using the programme https://calcdieta.ienva.org (g) | Patients will be followed over a period of 3 consecutive months | 
| Oral intake | PUFA (polyunsaturated fat acids): obtained from the nutritional analysis of a two-day dietary survey using the programme https://calcdieta.ienva.org (g) | Patients will be followed over a period of 3 consecutive months | 
| Oral intake | EPA: obtained from the nutritional analysis of a two-day dietary survey using the programme https://calcdieta.ienva.org (mg) | Patients will be followed over a period of 3 consecutive months | 
| Oral intake | DHA: obtained from the nutritional analysis of a two-day dietary survey using the programme https://calcdieta.ienva.org (mg) | Patients will be followed over a period of 3 consecutive months | 
| Oral intake | Fibre: obtained from the nutritional analysis of a two-day dietary survey using the programme https://calcdieta.ienva.org (g) | Patients will be followed over a period of 3 consecutive months | 
| Malnutrition Diagnosis | 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 | Patients will be followed over a period of 3 consecutive months |