Actively Recruiting
Effect of Plant Based High Energy High Protein Oral Nutritional Supplement on Nutritional Intake in Patients With or at Risk of Disease Related Malnutrition.
Led by Nutricia Research · Updated on 2025-09-24
80
Participants Needed
2
Research Sites
119 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The subjects will use study product twice daily for 8 weeks starting at Visit 1. The recommendation is to consume one serving in the morning and one in the afternoon / evening between meals. The duration of the study for each subject will be approximately 11 weeks, comprising a screening period of max 2 weeks, an intervention period of 8 weeks, and a follow up phone call 1 week after completion of the intervention. A blood sample will be drawn at visit 1 and visit 3.
CONDITIONS
Official Title
Effect of Plant Based High Energy High Protein Oral Nutritional Supplement on Nutritional Intake in Patients With or at Risk of Disease Related Malnutrition.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Identified at medium or high risk of malnutrition based on MUST score 1 or prescribed oral nutritional supplements and willing to switch to study products
- Require two servings of oral nutritional supplements per day (400 kcal; 20 g protein per serving) for at least 8 weeks as determined by a healthcare professional
- Medically and physically able to consume high energy high protein oral nutritional supplements
- Willing to maintain usual dietary habits during the study
- Willing to consume both plant based and dairy based oral nutritional supplements
You will not qualify if you...
- Known allergy to soy, cow's milk protein, or any ingredients in the study supplements
- Known intolerance to any ingredients in the study supplements (lactose intolerance acceptable if lactase used)
- Any contraindication to oral feeding such as gastrointestinal failure, complete intestinal obstruction, or major intraabdominal sepsis
- Active flare of inflammatory bowel disease defined by Harvey-Bradshaw Index >6 or Simple Clinical Colitis Activity Index >5
- Requirement for protein restricted diet, such as chronic kidney disease stage 4 or 5
- Need for enteral nutrition via tube or parenteral nutrition
- Following a vegan diet
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Meclinas
Mechelen, Belgium, 2800
Actively Recruiting
2
QClinical
Rotterdam, Netherlands
Actively Recruiting
Research Team
D
Danone Global Research & Innovation Center B.V.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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