Phase
Condition
Weight Loss
Diet And Nutrition
Treatment
Test Product: Plant based high energy high protein ONS
Control Product: Dairy based high energy high protein ONS
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Age ≥ 18 years
Identified as at medium or high risk of malnutrition based on:
MUST score ≥ 1 and / or
Being prescribed with ONS and willing and able to switch from pre-studyprescribed ONS to the Test or Control Product for participation in the study
In need of 2 servings of ONS/day (400 kcal; 20 gr protein per serving) for at least 8 weeks as determined by the treating healthcare professional.
Medically and physically able to consume high energy high protein ONS in the opinionof the Investigator.
Willing to maintain dietary habits for the duration of the study.
Willing to consume plant based as well as dairy based ONS
Exclusion
Exclusion Criteria:
Known allergy to soy, cow's milk protein or to any other ingredients as listed inthe study product composition (refer to the product information brochure (PIB) andthe appendix of this protocol).
Known intolerance to any ingredients as listed in the study product composition (refer to PIB and appendix of this protocol). Subjects with lactose intolerance whouse lactase may still be enrolled in the study.
Any contraindication to oral feeding per se, including gastrointestinal failure orsuppressed gastrointestinal function, complete intestinal obstruction and majorintraabdominal sepsis.
Active flare of inflammatory bowel disease as defined by Harvey-Bradshaw Index (HBI) >6 (Crohn's disease) or Simple Clinical Colitis Activity Index (SCCAI) >5 (ulcerative colitis).
Requiring a protein restricted diet as confirmed by a physician, for example chronickidney disease stage 4 and 5 (estimated by Glomerular Filtration Rate <30mL/min/1.73 m2).
Requiring enteral nutrition (via tube delivery) or parenteral nutrition.
Subjects following a vegan diet.
Study Design
Connect with a study center
Meclinas
Mechelen, 2800
BelgiumActive - Recruiting
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