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

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.

Study Overview

• Status: Recruiting
• Conditions: Cancer; Inflammatory Bowel Diseases; Malnutrition; Hiv; Chronic Obstructive Pulmonary Disease (COPD)
• Intervention / Treatment: Dietary supplement: Fortimel

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.

• Study Type: Interventional
• Enrollment (Estimated): 140
• Phase: Phase 4

Contacts and Locations

Study Locations

• Spain
  • Bilbao, Spain, 48013
    • Recruiting
    • Hospital Universitario de Basurto
    • Contact: Natalia Iglesias, MD; Phone Number: 944 00 60 00; Email: Nataliacovadonga.iglesiashernandez@osakidetza.eus
  • Córdoba, Spain, 14004
    • Recruiting
    • Hospital Universitario Reina Sofia
    • Contact: Alfonso Calañas, MD; Phone Number: 957 01 00 00; Email: contentine@gmail.com
  • Las Palmas de Gran Canaria, Spain, 35010
    • Recruiting
    • Hospital Universitario de Gran Canaria Doctor Negrin
    • Contact: Pedro L Pablos Velasco, MD; Phone Number: 928 45 00 00; Email: pablos.velasco@gmail.com
  • Madrid, Spain, 28935
    • Recruiting
    • Hospital Universitario de Móstoles
    • Contact: Araceli Ramos, MD; Phone Number: 916 64 86 00; Email: araceli.ramos@salud.madrid.org
  • Sevilla, Spain, 41013
    • Recruiting
    • Hospital Universitario Virgen Del Rocio
    • Contact: Pedro Pablo Garcia Luna, MD; Phone Number: 955 01 20 00; Email: garcialunapp@yahoo.es
  • Valladolid, Spain, 47003
    • Recruiting
    • Hospital Clínico Valladolid
    • Contact: Daniel Antonio De Luis Román, MD; Phone Number: 983420000; Email: dluisro@saludcastillayleon.es

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Fortimel Energy; Control: high-energy ONS 1.5 Kcal/m 200ml for 90 days	Dietary supplement: Fortimel; 2 bottles/day of the high energy ONS
Experimental: Fortimel PlantBased; Intervention: high-energy ONS 1.5 Kcal/m 200ml for 90 days	Dietary supplement: Fortimel; 2 bottles/day of the high energy ONS

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in muscle strength	Measured by dynamometry	From the baseline to final visit (12 weeks)
Change in calf circumference		From baseline to final visit (12 week)
Percentage of compliance	Taking into account the number of bottles per day taken, the ml of product and the ml left over.	During the study follow up
Changes in the gastrointestinal symptom scale (GSRS)	Total score	From the baseline to final visit (12 week)
ONS Satisfaction	Patients satisfaction taking ONS will be considered if a patient indicates a score of at least 8 points for overall satisfaction question.	Final visit (12 week)

Collaborators and Investigators

• Sponsor: Danone Specialized Nutrition

Study record dates

Study Major Dates

• Study Start (Actual): August 9, 2023
• Primary Completion (Estimated): May 31, 2024
• Study Completion (Estimated): May 31, 2024

Study Registration Dates

• First Submitted: September 14, 2023
• First Submitted That Met QC Criteria: September 20, 2023
• First Posted (Actual): September 26, 2023

Study Record Updates

• Last Update Posted (Actual): September 26, 2023
• Last Update Submitted That Met QC Criteria: September 20, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Respiratory Tract Diseases; Lung Diseases; Disease Attributes; Gastrointestinal Diseases; Nutrition Disorders; Gastroenteritis; Intestinal Diseases; Chronic Disease; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Inflammatory Bowel Diseases; Malnutrition
• Other Study ID Numbers: Fortimel PlantBased Spain 2022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No