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

Launched by DANONE SPECIALIZED NUTRITION · Sep 20, 2023

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a new plant-based high-energy nutritional supplement on malnourished patients. The goal is to see how well this new supplement helps patients gain weight compared to a standard high-energy supplement that contains animal protein. The study is open to adults aged 18 and older who are considered malnourished based on specific guidelines. Eligible participants may include those with conditions like cancer, chronic lung disease (COPD), inflammatory bowel diseases, or HIV, and who require extra nutrition for at least 12 weeks.

If you decide to participate, you will receive either the new plant-based supplement or the standard one for three months, and you'll need to drink two bottles of it each day. Throughout the trial, you’ll be asked to answer some questions about your health and nutrition. It’s important to note that certain individuals, such as those with allergies to milk or soy, or those who need special feeding methods like tubes, won’t be able to join the study. Overall, this trial aims to find out if a plant-based option can be a better choice for helping malnourished patients improve their nutrition.

Gender

ALL

Eligibility criteria

• 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