Clinical trial NCT05781178: Analysis of the Aetiological Factors of Malnutrition
Official title: Analysis of the Aetiological Factors of Malnutrition: Inflammation and Oral Intake
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Disease-related Malnutrition
Inflammation
Lead sponsor: Endocrinology and Clinical Nutrition Research Center, Spain
Sponsor class: OTHER
Collaborators: name: Adventia Pharma
First posted: 2023-03-23
Enrollment: 271
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with a diagnosis of DRM with the presence of an inflammatory response (CRP\>3 mg/dl).

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Blood biochemistry data
timeFrame: Patients will be followed over a period of 3 consecutive months
measure: Blood biochemistry data
timeFrame: Patients will be followed over a period of 3 consecutive months
measure: Blood biochemistry data
timeFrame: Patients will be followed over a period of 3 consecutive months
measure: Blood biochemistry data
timeFrame: Patients will be followed over a period of 3 consecutive months
measure: Blood biochemistry data
timeFrame: Patients will be followed over a period of 3 consecutive months
measure: Blood biochemistry data
timeFrame: Patients will be followed over a period of 3 consecutive months
measure: Blood biochemistry data
timeFrame: Patients will be followed over a period of 3 consecutive months
Secondary outcomes:
measure: Bioelectrical impedance data (model (50 kHz)
timeFrame: Patients will be followed over a period of 3 consecutive months
measure: Bioelectrical impedance data (model (50 kHz)
timeFrame: Patients will be followed over a period of 3 consecutive months
measure: Bioelectrical impedance data (model (50 kHz)
timeFrame: Patients will be followed over a period of 3 consecutive months
measure: Bioelectrical impedance data (model (50 kHz)
timeFrame: Patients will be followed over a period of 3 consecutive months
measure: Bioelectrical impedance data (model (50 kHz)
timeFrame: Patients will be followed over a period of 3 consecutive months
measure: Bioelectrical impedance data (model (50 kHz)
timeFrame: Patients will be followed over a period of 3 consecutive months
measure: Bioelectrical impedance data (model (50 kHz)
timeFrame: Patients will be followed over a period of 3 consecutive months
measure: Bioelectrical impedance data (model (50 kHz)
timeFrame: Patients will be followed over a period of 3 consecutive months
measure: Functional parameters
timeFrame: Patients will be followed over a period of 3 consecutive months
measure: Functional parameters
timeFrame: Patients will be followed over a period of 3 consecutive months
measure: Oral intake
timeFrame: Patients will be followed over a period of 3 consecutive months
measure: Oral intake
timeFrame: Patients will be followed over a period of 3 consecutive months
measure: Oral intake
timeFrame: Patients will be followed over a period of 3 consecutive months
measure: Oral intake
timeFrame: Patients will be followed over a period of 3 consecutive months
measure: Oral intake
timeFrame: Patients will be followed over a period of 3 consecutive months
measure: Oral intake
timeFrame: Patients will be followed over a period of 3 consecutive months
measure: Oral intake
timeFrame: Patients will be followed over a period of 3 consecutive months
measure: Oral intake
timeFrame: Patients will be followed over a period of 3 consecutive months
measure: Oral intake
timeFrame: Patients will be followed over a period of 3 consecutive months
measure: Malnutrition Diagnosis
timeFrame: Patients will be followed over a period of 3 consecutive months
Other outcomes:
Locations:
city: Ferrol
country: Spain
facility: Complejo Hospitalario Universitario de Ferrol
state: A Coruña
city: Santiago De Compostela
country: Spain
facility: Complejo Hospitalario Universitario de Santiago de Compostela
state: A Coruña
city: Santander
country: Spain
facility: Hospital Universitario Marqués de Valdecilla
state: Cantabria
city: Palma De Mallorca
country: Spain
facility: Hospital Universitario Son Espases
state: Islas Baleares
city: Vigo
country: Spain
facility: Complejo Hospitalario Universitario de Vigo
state: Pontevedra
city: Bilbao
country: Spain
facility: Hospital Universitario Basurto
state: Vizcaya
city: A Coruña
country: Spain
facility: Complejo Hospitalario Universitario de A Coruña
city: Badajoz
country: Spain
facility: Hospital Universitario de Badajoz
city: Granada
country: Spain
facility: Hospital Universitario Virgen de las Nieves
city: Madrid
country: Spain
facility: Hospital Clínico San Carlos
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
city: Málaga
country: Spain
facility: Hospital Universitario Virgen de la Victoria
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen del Rocío
city: Valencia
country: Spain
facility: Hospital Universitario y Politécnico La Fe
city: Valladolid
country: Spain
facility: Hospital Clínico Universitario de Valladolid
Study officials:
affiliation: Endocrinology and Nutrition Department. Hospital Clínico Universitario de Valladolid (Spain)
name: Daniel de Luis Roman, Prof
role: STUDY_DIRECTOR
affiliation: Endocrinology and Nutrition Department. Hospital Universitario La Paz (Spain)
name: Samara Palma Milla, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Endocrinology and Nutrition Department. Complejo Hospitalario Universitario de A Coruña (Spain)
name: Alfonso Vidal Casariego, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Endocrniology and Nutrition Department. Hospital Universitario Virgen de la Victoria (Spain)
name: José M García Almeida, PhD
role: PRINCIPAL_INVESTIGATOR
References: