Impact of a New Plant-based High-energy Oral Nutritional Supplement on Nutritional Outcomes in Malnourished Patients

NCT06055543 | Unknown Phase 4

• 1 other identifier: Fortimel PlantBased Spain 2022
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 6

Brief Summary

This study aims to compare nutritional outcomes in terms of percentage of weight gain between a new planted-based high-energy ONS and a standard high-energy ONS with animal protein (cow's mil protein) in patients at malnutrition according to Global Leadership Initiative on Malnutrition (GLIM) criteria.

Conditions

Malnutrition; Cancer; Inflammatory Bowel Diseases; Chronic Obstructive Pulmonary Disease (COPD); Hiv

Outcome Measures

Primary Outcomes (2)

• Change in weight

  Change in weight percentage

  Changes between baseline and final visit (12 weeks).

• Improvement in nutritional status

  Improvement in nutritional status according to the GLIM criteria. A change in classification category from grade 2 of malnutrition to grade 1 or not meet GLIM criteria, as well as a change from grade 1 to not meet GLIM criteria are considered an improvement.

  From the baseline to the final visit (12 weeks)

Secondary Outcomes (5)

• Change in muscle strength

  From the baseline to final visit (12 weeks)

• Change in calf circumference

  From baseline to final visit (12 week)

• Percentage of compliance

  During the study follow up

• Changes in the gastrointestinal symptom scale (GSRS)

  From the baseline to final visit (12 week)

• ONS Satisfaction

  Final visit (12 week)

Study Arms (2)

Fortimel Energy

ACTIVE COMPARATOR

Control: high-energy ONS 1.5 Kcal/m 200ml for 90 days

Dietary Supplement: Fortimel

Fortimel PlantBased

EXPERIMENTAL

Intervention: high-energy ONS 1.5 Kcal/m 200ml for 90 days

Dietary Supplement: Fortimel

Interventions

Fortimel DIETARY_SUPPLEMENT

2 bottles/day of the high energy ONS

Fortimel Energy; Fortimel PlantBased

Eligibility Criteria

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

You may qualify if:

• Patients ≥ 18 years old
• Malnourished patients according to GLIM criteria
• Patients with a high energy requirement (1.5kcal/ml) requiring the intake of 2 bottles of ONS per day for at least 12 weeks
• Patients presenting any of the following clinical situations:
• Elderly patients requiring oral nutritional support
• Patients with digestive pathology including but not restricted to inflammatory bowel disease, short bowel syndrome, pancreatitis, without active malabsorption and maldigestion.
• Chronic diseases such as COPD, mild to moderate renal disease, HIV
• Oncologic patients with Eastern Cooperative Oncology Group (ECOG) 0-1
• Patients who have given their consent to participate
• Patients who, in the opinion of the physician, have the capacity to answer the study questionnaires themselves or their caregivers

You may not qualify if:

• Patients who need ONS due to surgical or acute illness\*
• Patients with known intolerance or allergy to cow's milk, soya or peas
• Patients with hyperthyroidism. Patients with uncontrolled hypothyroidism
• Uncontrolled diabetic patients (HbA1c \>8%)
• Patients requiring enteral nutrition by tube or ostomy
• Patients with moderate and serious renal insufficiency \< 30ml/min/1,73 m2
• Patients who have value creatinine:
• ,70 mg/dl - 150,31umol/L Men
• ,50 mg/dl - 132,63umol/L Women
• Patients with levels of haemoglobin \<10 g/dl, transferrin \<150 mg /dl

Sponsors & Collaborators

• Danone Specialized Nutrition: lead

Study Sites (6)

Hospital Universitario de Basurto

Bilbao, 48013, Spain

RECRUITING

Hospital Universitario Reina Sofía

Córdoba, 14004, Spain

RECRUITING

Hospital Universitario de Gran Canaria Doctor Negrín

Las Palmas de Gran Canaria, 35010, Spain

RECRUITING

Hospital Universitario de Móstoles

Madrid, 28935, Spain

RECRUITING

Hospital Universitario Virgen del Rocío

Seville, 41013, Spain

RECRUITING

Hospital Clínico Valladolid

Valladolid, 47003, Spain

RECRUITING

Related Publications (1)

• Iglesias Hernandez NC, Ramos Carrasco A, De Luis Roman DA, de Pablos-Velasco PL, Calanas Continente A, Rodriguez Soto MJ, Lopez-Gomez JJ, Comi-Diaz C, Garcia-Rey S, Perez-Rambla C, Garcia-Luna PP. Effect of a new plant-based high-energy oral nutritional supplement in adult malnourished patients: an open-label, randomized clinical trial. Front Nutr. 2025 Nov 20;12:1667954. doi: 10.3389/fnut.2025.1667954. eCollection 2025.

  PMID: 41356829 DERIVED

MeSH Terms

Conditions

Malnutrition; Neoplasms; Inflammatory Bowel Diseases; Pulmonary Disease, Chronic Obstructive; Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

Nutrition Disorders; Nutritional and Metabolic Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2023
• First Posted: September 26, 2023
• Study Start: August 9, 2023
• Primary Completion: May 31, 2024
• Study Completion: May 31, 2024
• Last Updated: September 26, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

ES (6)