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

Phase 4

Recruiting

• Conditions: Chronic Obstructive Pulmonary Disease (COPD); Hiv; Malnutrition; Cancer; Inflammatory Bowel Diseases
• Interventions: Dietary Supplement: Fortimel

• Registration Number: NCT06055543
• Lead Sponsor: Danone Specialized Nutrition

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.

Study Timeline

• Study Start: 2023-08-09
• Status Verified: 2023-09
• Study First Submitted: 2023-09-14
• Study First Submitted QC: 2023-09-20
• Last Update Submitted: 2023-09-20
• Study First Posted: 2023-09-26
• Last Update Posted: 2023-09-26
• Primary Completion: 2024-05-31
• Study Completion: 2024-05-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 140

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fortimel Energy	Fortimel	Control: high-energy ONS 1.5 Kcal/m 200ml for 90 days
Fortimel PlantBased	Fortimel	Intervention: high-energy ONS 1.5 Kcal/m 200ml for 90 days

Primary Outcome Measures

Name	Time	Method
Change in weight	Changes between baseline and final visit (12 weeks).	Change in weight percentage
Improvement in nutritional status	From the baseline to the final visit (12 weeks)	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.

Secondary Outcome Measures

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

Trial Locations

Locations (6)

Hospital Universitario de Basurto; 🇪🇸 Bilbao, Spain

Hospital Universitario Reina Sofía; 🇪🇸 Córdoba, Spain

Hospital Universitario de Gran Canaria Doctor Negrín; 🇪🇸 Las Palmas de Gran Canaria, Spain

Hospital Universitario de Móstoles; 🇪🇸 Madrid, Spain

Hospital Universitario Virgen del Rocío; 🇪🇸 Sevilla, Spain

Hospital Clínico Valladolid; 🇪🇸 Valladolid, Spain