Status:
UNKNOWN
Impact of a New Plant-based High-energy Oral Nutritional Supplement on Nutritional Outcomes in Malnourished Patients
Lead Sponsor:
Danone Specialized Nutrition
Conditions:
Malnutrition
Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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)...
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 Malnutri...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 9 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 31 2024
Estimated Enrollment :
140 Patients enrolled
Trial Details
Trial ID
NCT06055543
Start Date
August 9 2023
End Date
May 31 2024
Last Update
September 26 2023
Active Locations (6)
Enter a location and click search to find clinical trials sorted by distance.
1
Hospital Universitario de Basurto
Bilbao, Spain, 48013
2
Hospital Universitario Reina Sofía
Córdoba, Spain, 14004
3
Hospital Universitario de Gran Canaria Doctor Negrín
Las Palmas de Gran Canaria, Spain, 35010
4
Hospital Universitario de Móstoles
Madrid, Spain, 28935