Analysis of the Aetiological Factors of Malnutrition

NCT05781178 | Completed

• 1 other identifier: PI23 3024
• Study Type: observational
• Target: 271
• Locations: 1 country
• Sites: 15

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.

Conditions

Disease-related Malnutrition; Inflammation

Outcome Measures

Primary Outcomes (7)

• 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 Outcomes (20)

• Bioelectrical impedance data (model (50 kHz)

  Patients will be followed over a period of 3 consecutive months

• Bioelectrical impedance data (model (50 kHz)

  Patients will be followed over a period of 3 consecutive months

• Bioelectrical impedance data (model (50 kHz)

  Patients will be followed over a period of 3 consecutive months

• Bioelectrical impedance data (model (50 kHz)

  Patients will be followed over a period of 3 consecutive months

• Bioelectrical impedance data (model (50 kHz)

  Patients will be followed over a period of 3 consecutive months

Interventions

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

Also known as: Physical activity

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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
• Treatment with biological therapies (antibodies) at the current time or one month in advance
• 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.

Sponsors & Collaborators

• Endocrinology and Clinical Nutrition Research Center, Spain: lead
• Adventia Pharma: collaborator

Study Sites (15)

Complejo Hospitalario Universitario de Ferrol

Ferrol, A Coruña, 15405, Spain

Location

Complejo Hospitalario Universitario de Santiago de Compostela

Santiago de Compostela, A Coruña, 15706, Spain

Location

Hospital Universitario Son Espases

Palma de Mallorca, Balearic Islands, 07120, Spain

Location

Hospital Universitario Marqués de Valdecilla

Santander, Cantabria, 39008, Spain

Location

Complejo Hospitalario Universitario de Vigo

Vigo, Pontevedra, 36312, Spain

Location

Hospital Universitario Basurto

Bilbao, Vizcaya, 48013, Spain

Location

Complejo Hospitalario Universitario de A Coruña

A Coruña, 15008, Spain

Location

Hospital Universitario de Badajoz

Badajoz, 06080, Spain

Location

Hospital Universitario Virgen de las Nieves

Granada, 18014, Spain

Location

Hospital Clínico San Carlos

Madrid, 28040, Spain

Location

Hospital Universitario La Paz

Madrid, 28046, Spain

Location

Hospital Universitario Virgen de la Victoria

Málaga, Spain

Location

Hospital Universitario Virgen del Rocío

Seville, 41013, Spain

Location

Hospital Universitario y Politécnico La Fe

Valencia, 46026, Spain

Location

Hospital Clínico Universitario de Valladolid

Valladolid, 47005, Spain

Location

MeSH Terms

Conditions

Inflammation

Interventions

Docosahexaenoic Acids; Exercise

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Fatty Acids, Omega-3; Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fatty Acids, Unsaturated; Fatty Acids; Fish Oils; Oils; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• 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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 28, 2023
• First Posted: March 23, 2023
• Study Start: May 2, 2023
• Primary Completion: May 17, 2024
• Study Completion: September 11, 2024
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

ES (15)