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

Study Overview
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Brief Summary
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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
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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.

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

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

Intervention / Treatment
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* Dietary Supplement: Fortimel


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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) |