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

Danone

Status and phase

Enrolling

Phase 4

Conditions

Malnutrition

Cancer

Hiv

Inflammatory Bowel Diseases

Chronic Obstructive Pulmonary Disease (COPD)

Treatments

Dietary Supplement: Fortimel

Study type

Interventional

Funder types

Industry

Identifiers

NCT06055543

Fortimel PlantBased Spain 2022

Details and patient eligibility

About

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.

Full 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.

Enrollment

140 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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