Analysis of the Aetiological Factors of Malnutrition

NCT ID: NCT05781178

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 271 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-05-02
• Study Completion Date: 2024-09-11

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

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

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

Physical activity

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Adventia Pharma

INDUSTRY

Sponsor Role: collaborator

Endocrinology and Clinical Nutrition Research Center, Spain

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Daniel de Luis Roman, Prof

Role: STUDY_DIRECTOR

Endocrinology and Nutrition Department. Hospital Clínico Universitario de Valladolid (Spain)

Samara Palma Milla, PhD

Role: PRINCIPAL_INVESTIGATOR

Endocrinology and Nutrition Department. Hospital Universitario La Paz (Spain)

Alfonso Vidal Casariego, PhD

Role: PRINCIPAL_INVESTIGATOR

Endocrinology and Nutrition Department. Complejo Hospitalario Universitario de A Coruña (Spain)

José M García Almeida, PhD

Role: PRINCIPAL_INVESTIGATOR

Endocrniology and Nutrition Department. Hospital Universitario Virgen de la Victoria (Spain)

Locations

Complejo Hospitalario Universitario de Ferrol

Ferrol, A Coruña, Spain

Complejo Hospitalario Universitario de Santiago de Compostela

Santiago de Compostela, A Coruña, Spain

Hospital Universitario Son Espases

Palma de Mallorca, Balearic Islands, Spain

Hospital Universitario Marqués de Valdecilla

Santander, Cantabria, Spain

Complejo Hospitalario Universitario de Vigo

Vigo, Pontevedra, Spain

Hospital Universitario Basurto

Bilbao, Vizcaya, Spain

Complejo Hospitalario Universitario de A Coruña

A Coruña, , Spain

Hospital Universitario de Badajoz

Badajoz, , Spain

Hospital Universitario Virgen de las Nieves

Granada, , Spain

Hospital Clínico San Carlos

Madrid, , Spain

Hospital Universitario La Paz

Madrid, , Spain

Hospital Universitario Virgen de la Victoria

Málaga, , Spain

Hospital Universitario Virgen del Rocío

Seville, , Spain

Hospital Universitario y Politécnico La Fe

Valencia, , Spain

Hospital Clínico Universitario de Valladolid

Valladolid, , Spain

Countries

Spain

Other Identifiers

PI23 3024

Identifier Type: -

Identifier Source: org_study_id