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NCT Number: NCT05781178

Analysis of the Aetiological Factors of Malnutrition

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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Key information

Conditions

Disease-related Malnutrition Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Complejo Hospitalario Universitario de Ferrol, Ferrol, A Coruña, Spain

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Other names: Physical activity

Primary outcomes

  1. Blood biochemistry data

    Time frame: Patients will be followed over a period of 3 consecutive months

    Albumin (g/dL)

  2. Blood biochemistry data

    Time frame: Patients will be followed over a period of 3 consecutive months

    Prealbumin (mg/dL)

  3. Blood biochemistry data

    Time frame: Patients will be followed over a period of 3 consecutive months

    C-reactive protein (mg/L)

  4. Blood biochemistry data

    Time frame: Patients will be followed over a period of 3 consecutive months

    Ferritin (ng/mL)

  5. Blood biochemistry data

    Time frame: Patients will be followed over a period of 3 consecutive months

    Neutrophils (x103/μL)

  6. Blood biochemistry data

    Time frame: Patients will be followed over a period of 3 consecutive months

    Lymphocytes (x103/μL)

  7. Blood biochemistry data

    Time frame: Patients will be followed over a period of 3 consecutive months

    Platelets (x103/μL)

Secondary outcomes

  1. Bioelectrical impedance data (model (50 kHz)

    Time frame: Patients will be followed over a period of 3 consecutive months

    TBW (total body water, L)

  2. Bioelectrical impedance data (model (50 kHz)

    Time frame: Patients will be followed over a period of 3 consecutive months

    ECW (extracellular water, L)

  3. Bioelectrical impedance data (model (50 kHz)

    Time frame: Patients will be followed over a period of 3 consecutive months

    ICW (intracellular water, L)

  4. Bioelectrical impedance data (model (50 kHz)

    Time frame: Patients will be followed over a period of 3 consecutive months

    FFM (lean mass, kg)

  5. Bioelectrical impedance data (model (50 kHz)

    Time frame: Patients will be followed over a period of 3 consecutive months

    FM (fat mass, kg)

  6. Bioelectrical impedance data (model (50 kHz)

    Time frame: Patients will be followed over a period of 3 consecutive months

    BCM (body cell mass, kg)

  7. Bioelectrical impedance data (model (50 kHz)

    Time frame: Patients will be followed over a period of 3 consecutive months

    ASMM (appendicular skeletal muscle mass, kg)

  8. Bioelectrical impedance data (model (50 kHz)

    Time frame: Patients will be followed over a period of 3 consecutive months

    SMI (skeletal muscle mass index, kg)

  9. Functional parameters

    Time frame: Patients will be followed over a period of 3 consecutive months

    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

  10. Functional parameters

    Time frame: Patients will be followed over a period of 3 consecutive months

    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

  11. Oral intake

    Time frame: Patients will be followed over a period of 3 consecutive months

    Energy: obtained from the nutritional analysis of a two-day dietary survey using the programme https://calcdieta.ienva.org (kcal)

  12. Oral intake

    Time frame: Patients will be followed over a period of 3 consecutive months

    Protein: obtained from the nutritional analysis of a two-day dietary survey using the programme https://calcdieta.ienva.org (g)

  13. Oral intake

    Time frame: Patients will be followed over a period of 3 consecutive months

    Carbohydrate: obtained from the nutritional analysis of a two-day dietary survey using the programme https://calcdieta.ienva.org (g)

  14. Oral intake

    Time frame: Patients will be followed over a period of 3 consecutive months

    Fat: obtained from the nutritional analysis of a two-day dietary survey using the programme https://calcdieta.ienva.org (g)

  15. Oral intake

    Time frame: Patients will be followed over a period of 3 consecutive months

    MUFA (monounsaturated fat acids): obtained from the nutritional analysis of a two-day dietary survey using the programme https://calcdieta.ienva.org (g)

  16. Oral intake

    Time frame: Patients will be followed over a period of 3 consecutive months

    PUFA (polyunsaturated fat acids): obtained from the nutritional analysis of a two-day dietary survey using the programme https://calcdieta.ienva.org (g)

  17. Oral intake

    Time frame: Patients will be followed over a period of 3 consecutive months

    EPA: obtained from the nutritional analysis of a two-day dietary survey using the programme https://calcdieta.ienva.org (mg)

  18. Oral intake

    Time frame: Patients will be followed over a period of 3 consecutive months

    DHA: obtained from the nutritional analysis of a two-day dietary survey using the programme https://calcdieta.ienva.org (mg)

  19. Oral intake

    Time frame: Patients will be followed over a period of 3 consecutive months

    Fibre: obtained from the nutritional analysis of a two-day dietary survey using the programme https://calcdieta.ienva.org (g)

  20. Malnutrition Diagnosis

    Time frame: Patients will be followed over a period of 3 consecutive months

    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

Sponsors and collaborators

Lead sponsor

Endocrinology and Clinical Nutrition Research Center, Spain

Other

Collaborators

  • Adventia Pharma

Registry information

Official study title

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

Acronym: AFEDIN

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Mar 23, 2023
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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