Effect of Plant Based High Energy High Protein Oral Nutritional Supplement on Nutritional Intake in Patients With or at Risk of Disease Related Malnutrition.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Test Product: Plant based high energy high protein ONS, Control Product: Dairy based high energy high protein ONS.
- Who it may be relevant to
- Registry conditions: Disease Related Malnutrition. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Belgium, Netherlands
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Dietary supplement Test Product: Plant based high energy high protein ONS
Plant based high energy high protein ONS 2 servings/day for a period of 8 weeks. - Dietary supplement Control Product: Dairy based high energy high protein ONS
Dairy based high energy high protein ONS 2 servings equivalent in energy \& protein for a period of 8 weeks.
Primary outcome measures
- To investigate the effect of PB HEHP ONS compared to DB HEHP ONS on nutritional intake (energy & protein) in subjects with or at risk of Disease Related Malnutrition (DRM) and/or prescribed with ONS. [Time frame: 11 weeks]
Eligibility criteria
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-study prescribed 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 opinion of 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 criteria
- Known allergy to soy, cow's milk protein or to any other ingredients as listed in the study product composition (refer to the product information brochure (PIB) and the 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 who use lactase may still be enrolled in the study.
- Any contraindication to oral feeding per se, including gastrointestinal failure or suppressed gastrointestinal function, complete intestinal obstruction and major intraabdominal 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 chronic kidney disease stage 4 and 5 (estimated by Glomerular Filtration Rate <30 mL/min/1.73 m2).
- Requiring enteral nutrition (via tube delivery) or parenteral nutrition.
- Subjects following a vegan diet.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Supportive care
Study locations
Belgium · 1 center
- Meclinas — Mechelen
Netherlands · 1 center
- QClinical — Rotterdam
Identifiers
NCT: NCT06781619 · 23REX0061267