Analysis of the Aetiological Factors of Malnutrition

Inflammation Clinical Trial

— AFEDIN  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05781178
• Other study ID #: PI23 3024
• Status: Recruiting
• Start date: May 2, 2023
• Est. completion date: June 2024

Study information

• Verified date: September 2023
• Source: Endocrinology and Clinical Nutrition Research Center, Spain
• Contact: Daniel de Luis Román, Prof
• Phone: +34983420000
• Email: daluisro[@]saludcastillayleon.es
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: June 2024
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Disease-related Malnutrition
• Inflammation
• Malnutrition

Intervention

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

Locations

Country	Name	City	State
Spain	Complejo Hospitalario Universitario de A Coruña	A Coruña
Spain	Hospital Universitario La Paz	Madrid
Spain	Hospital Universitario Virgen de la Victoria	Málaga
Spain	Hospital Universitario Marqués de Valdecilla	Santander	Cantabria
Spain	Complejo Hospitalario Universitario de Santiago de Compostela	Santiago De Compostela	A Coruña
Spain	Hospital Clínico Universitario de Valladolid	Valladolid

Sponsors (2)

Lead Sponsor	Collaborator
Endocrinology and Clinical Nutrition Research Center, Spain	Adventia Pharma

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood biochemistry data	Albumin (g/dL)	Patients will be followed over a period of 3 consecutive months
Primary	Blood biochemistry data	Prealbumin (mg/dL)	Patients will be followed over a period of 3 consecutive months
Primary	Blood biochemistry data	C-reactive protein (mg/L)	Patients will be followed over a period of 3 consecutive months
Primary	Blood biochemistry data	Ferritin (ng/mL)	Patients will be followed over a period of 3 consecutive months
Primary	Blood biochemistry data	Neutrophils (x103/µL)	Patients will be followed over a period of 3 consecutive months
Primary	Blood biochemistry data	Lymphocytes (x103/µL)	Patients will be followed over a period of 3 consecutive months
Primary	Blood biochemistry data	Platelets (x103/µL)	Patients will be followed over a period of 3 consecutive months
Secondary	Bioelectrical impedance data (model (50 kHz)	TBW (total body water, L)	Patients will be followed over a period of 3 consecutive months
Secondary	Bioelectrical impedance data (model (50 kHz)	ECW (extracellular water, L)	Patients will be followed over a period of 3 consecutive months
Secondary	Bioelectrical impedance data (model (50 kHz)	ICW (intracellular water, L)	Patients will be followed over a period of 3 consecutive months
Secondary	Bioelectrical impedance data (model (50 kHz)	FFM (lean mass, kg)	Patients will be followed over a period of 3 consecutive months
Secondary	Bioelectrical impedance data (model (50 kHz)	FM (fat mass, kg)	Patients will be followed over a period of 3 consecutive months
Secondary	Bioelectrical impedance data (model (50 kHz)	BCM (body cell mass, kg)	Patients will be followed over a period of 3 consecutive months
Secondary	Bioelectrical impedance data (model (50 kHz)	ASMM (appendicular skeletal muscle mass, kg)	Patients will be followed over a period of 3 consecutive months
Secondary	Bioelectrical impedance data (model (50 kHz)	SMI (skeletal muscle mass index, kg)	Patients will be followed over a period of 3 consecutive months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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