Analysis of the Aetiological Factors of Malnutrition (AFEDIN)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Inflammation; Disease-related Malnutrition
• Intervention / Treatment: Dietary supplement: Oral nutritional supplement rich in omega-3 and olive oil polyphenols

• Study Type: Observational
• Enrollment (Estimated): 500

Contacts and Locations

• Study Contact: Name: Daniel de Luis Román, Prof; Phone Number: +34983420000; Email: daluisro@saludcastillayleon.es

Study Locations

• Spain
  • A Coruña, Spain, 15008
    • Recruiting
    • Complejo Hospitalario Universitario de A Coruña
    • Contact: Alfonso Vidal Casariego, PhD; Email: alfonso.vidal.casariego@sergas.es
  • Madrid, Spain, 28046
    • Not yet recruiting
    • Hospital Universitario La Paz
    • Contact: Samara Palma Milla, PhD; Email: palmamillasamara@gmail.com
  • Málaga, Spain
    • Not yet recruiting
    • Hospital Universitario Virgen de la Victoria
    • Contact: José M García Almeida, PhD; Email: jgarciaalmeida@gmail.com
    • Sub-Investigator: Isabel Vegas Aguilar
  • Valladolid, Spain, 47005
    • Recruiting
    • Hospital Clínico Universitario de Valladolid
    • Contact: Daniel A de Luis Román, Prof; Email: daluisro@saludcastillayleon.es
    • Sub-Investigator: Juan J López Gómez, PhD
    • Sub-Investigator: Rebeca Jiménez
    • Sub-Investigator: Olatz Izaola Jáuregui
    • Sub-Investigator: David Primo Martín
  • A Coruña
    • Santiago De Compostela, A Coruña, Spain, 15706
      • Not yet recruiting
      • Complejo Hospitalario Universitario de Santiago de Compostela
      • Contact: Miguel A Martínez-Olmos, PhD
  • Cantabria
    • Santander, Cantabria, Spain, 39008
      • Not yet recruiting
      • Hospital Universitario Marqués de Valdecilla
      • Contact: Coral Montalbán Carrasco, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with a diagnosis of DRM with the presence of an inflammatory response (CRP>3 mg/dl).

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Endocrinology and Clinical Nutrition Research Center, Spain
• Collaborators: Adventia Pharma
• Investigators: Study Director: Daniel de Luis Roman, Prof, Endocrinology and Nutrition Department. Hospital Clínico Universitario de Valladolid (Spain); Principal Investigator: 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)

Study record dates

Study Major Dates

• Study Start (Actual): May 2, 2023
• Primary Completion (Estimated): December 1, 2023
• Study Completion (Estimated): June 1, 2024

Study Registration Dates

• First Submitted: February 28, 2023
• First Submitted That Met QC Criteria: March 10, 2023
• First Posted (Actual): March 23, 2023

Study Record Updates

• Last Update Posted (Actual): September 11, 2023
• Last Update Submitted That Met QC Criteria: September 7, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nutrition Disorders; Inflammation; Malnutrition
• Other Study ID Numbers: PI23 3024

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No