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| Name | Class |
|---|---|
| Adventia Pharma | INDUSTRY |
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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oral nutritional supplement rich in omega-3 and olive oil polyphenols | Dietary Supplement | Nutritional intervention with an oral nutrition supplement with anti-inflammatory effect and a programme of physical exercise |
|
| 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 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with a diagnosis of DRM with the presence of an inflammatory response (CRP>3 mg/dl).
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| Name | Affiliation | Role |
|---|---|---|
| Daniel de Luis Roman, Prof | Endocrinology and Nutrition Department. Hospital Clínico Universitario de Valladolid (Spain) | Study Director |
| Samara Palma Milla, PhD | Endocrinology and Nutrition Department. Hospital Universitario La Paz (Spain) | Principal Investigator |
| Alfonso Vidal Casariego, PhD | Endocrinology and Nutrition Department. Complejo Hospitalario Universitario de A Coruña (Spain) | Principal Investigator |
| José M García Almeida, PhD | Endocrniology and Nutrition Department. Hospital Universitario Virgen de la Victoria (Spain) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Complejo Hospitalario Universitario de Ferrol | Ferrol | A Coruña | 15405 | Spain | ||
| Complejo Hospitalario Universitario de Santiago de Compostela |
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| 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 |
| Santiago de Compostela |
| A Coruña |
| 15706 |
| Spain |
| Hospital Universitario Son Espases | Palma de Mallorca | Balearic Islands | 07120 | Spain |
| Hospital Universitario Marqués de Valdecilla | Santander | Cantabria | 39008 | Spain |
| Complejo Hospitalario Universitario de Vigo | Vigo | Pontevedra | 36312 | Spain |
| Hospital Universitario Basurto | Bilbao | Vizcaya | 48013 | Spain |
| Complejo Hospitalario Universitario de A Coruña | A Coruña | 15008 | Spain |
| Hospital Universitario de Badajoz | Badajoz | 06080 | Spain |
| Hospital Universitario Virgen de las Nieves | Granada | 18014 | Spain |
| Hospital Clínico San Carlos | Madrid | 28040 | Spain |
| Hospital Universitario La Paz | Madrid | 28046 | Spain |
| Hospital Universitario Virgen de la Victoria | Málaga | Spain |
| Hospital Universitario Virgen del Rocío | Seville | 41013 | Spain |
| Hospital Universitario y Politécnico La Fe | Valencia | 46026 | Spain |
| Hospital Clínico Universitario de Valladolid | Valladolid | 47005 | Spain |
| ID | Term |
|---|---|
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D004281 | Docosahexaenoic Acids |
| D015444 | Exercise |
| ID | Term |
|---|---|
| D015525 | Fatty Acids, Omega-3 |
| D004042 | Dietary Fats, Unsaturated |
| D004041 | Dietary Fats |
| D005223 | Fats |
| D008055 | Lipids |
| D005231 | Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D005395 | Fish Oils |
| D009821 | Oils |
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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