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

Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06055543
• Other study ID #: Fortimel PlantBased Spain 2022
• Status: Recruiting
• Phase: Phase 4
• Start date: August 9, 2023
• Est. completion date: May 31, 2024

Study information

• Verified date: September 2023
• Source: Danone Specialized Nutrition
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 140
• Est. completion date: May 31, 2024
• Est. primary completion date: May 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Dietary Supplement:
• Fortimel
2 bottles/day of the high energy ONS

Locations

Country	Name	City	State
Spain	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

Sponsors (1)

Lead Sponsor	Collaborator
Danone Specialized Nutrition

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in weight	Change in weight percentage	Changes between baseline and final visit (12 weeks).
Primary	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	Change in muscle strength	Measured by dynamometry	From the baseline to final visit (12 weeks)
Secondary	Change in calf circumference		From baseline to final visit (12 week)
Secondary	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
Secondary	Changes in the gastrointestinal symptom scale (GSRS)	Total score	From the baseline to final visit (12 week)
Secondary	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)