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

NCT ID: NCT06055543

Last Updated: 2023-09-26

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 140 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-09
• Study Completion Date: 2024-05-31

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.

Detailed Description

Due to the increasingly pressing need to develop an oral nutritional supplement (ONS) that does not contain animal ingredients, Fortimel PlantBased, suitable for patients with Disease-Related Malnutrition or who wish to avoid or reduce the consumption of animal products for dietary or lifestyle reasons, is being promoted. At the same time, it is also a therapeutic option to be considered in the population with allergy or intolerance to cow's milk protein. Therefore, the aim is to offer an adapted therapeutic nutritional solution that guarantees nutritional results that are not inferior than ONS with animal protein (cow's milk protein).

This study was designed as an open-label randomized controlled non-inferiority trial with two arms: a new planted-based ONS (Fortimel PlantBased) as the intervention arm and standard ONS (Fortimel Energy) as the control arm, both high-energy formulas (1.5 kcal/m; 200ml).

The study will be carried out in patients at malnutrition according to Global Leadership Initiative on Malnutrition (GLIM) criteria, who need to supplement their diet by taking a high-energy ONS for at least 12 weeks. These patients will be treated and follow-up by the Endocrinology and Nutrition services of 6 public hospitals in Spain.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Fortimel Energy

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

Group Type: ACTIVE_COMPARATOR

Fortimel

Intervention Type: DIETARY_SUPPLEMENT

2 bottles/day of the high energy ONS

Fortimel PlantBased

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

Group Type: EXPERIMENTAL

Fortimel

Intervention Type: DIETARY_SUPPLEMENT

2 bottles/day of the high energy ONS

Interventions

Fortimel

2 bottles/day of the high energy ONS

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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:

• 1,70 mg/dl - 150,31umol/L Men
• 1,50 mg/dl - 132,63umol/L Women
• Patients with levels of haemoglobin <10 g/dl, transferrin <150 mg /dl

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

Sponsors

Danone Specialized Nutrition

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hospital Universitario de Basurto

Bilbao, , Spain

Site Status: RECRUITING

Hospital Universitario Reina Sofía

Córdoba, , Spain

Site Status: RECRUITING

Hospital Universitario de Gran Canaria Doctor Negrín

Las Palmas de Gran Canaria, , Spain

Site Status: RECRUITING

Hospital Universitario de Móstoles

Madrid, , Spain

Site Status: RECRUITING

Hospital Universitario Virgen del Rocío

Seville, , Spain

Site Status: RECRUITING

Hospital Clínico Valladolid

Valladolid, , Spain

Site Status: RECRUITING

Countries

Spain

Facility Contacts

Natalia Iglesias, MD

Role: primary

Nataliacovadonga.iglesiashernandez@osakidetza.eus

944 00 60 00

Alfonso Calañas, MD

Role: primary

contentine@gmail.com

957 01 00 00

Pedro L Pablos Velasco, MD

Role: primary

pablos.velasco@gmail.com

928 45 00 00

Araceli Ramos, MD

Role: primary

araceli.ramos@salud.madrid.org

916 64 86 00

Pedro Pablo Garcia Luna, MD

Role: primary

garcialunapp@yahoo.es

955 01 20 00

Daniel Antonio De Luis Román, MD

Role: primary

dluisro@saludcastillayleon.es

983420000

Other Identifiers

Fortimel PlantBased Spain 2022

Identifier Type: -

Identifier Source: org_study_id