Plant-based nutritional supplement for patients at risk of malnutrition

Effect of Plant Based High Energy High Protein Oral Nutritional Supplement on Nutritional Intake in Patients With or at Risk of Disease Related Malnutrition.

This study tests whether a plant-based nutritional supplement can help people at risk of malnutrition improve their diet and health compared to a dairy-based option.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 80 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Nutricia Research (Industry-sponsored)
• Locations: 2 sites (Mechelen and 1 other locations)
• Trial ID: NCT06781619 on ClinicalTrials.gov

What this trial studies

This study evaluates the effect of a plant-based high energy, high protein oral nutritional supplement on the nutritional intake of patients who are at risk of disease-related malnutrition. Participants will consume the supplement twice daily for eight weeks, with a follow-up assessment one week after the intervention. The study includes a screening period and involves blood sample collection at the beginning and end of the intervention. A control group will receive a dairy-based equivalent for comparison.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older who are identified as being at medium or high risk of malnutrition and require oral nutritional supplements.

Not a fit: Patients with known allergies or intolerances to the ingredients in the study products will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could improve nutritional intake and overall health outcomes for patients at risk of malnutrition.

How similar studies have performed: Other studies have shown positive outcomes with similar nutritional interventions, suggesting potential for success in this approach.

Eligibility criteria

Inclusion Criteria:

1. Age ≥ 18 years
2. Identified as at medium or high risk of malnutrition based on:

   1. MUST score ≥ 1 and / or
   2. 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
3. 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.
4. Medically and physically able to consume high energy high protein ONS in the opinion of the Investigator.
5. Willing to maintain dietary habits for the duration of the study.
6. Willing to consume plant based as well as dairy based ONS

Exclusion Criteria:

1. 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).
2. 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.
3. Any contraindication to oral feeding per se, including gastrointestinal failure or suppressed gastrointestinal function, complete intestinal obstruction and major intraabdominal sepsis.
4. 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).
5. 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).
6. Requiring enteral nutrition (via tube delivery) or parenteral nutrition.
7. Subjects following a vegan diet.

Where this trial is running

Mechelen and 1 other locations

• Meclinas — Mechelen, Belgium (Recruiting)
• QClinical — Rotterdam, Netherlands (Recruiting)

Study contacts

• Study coordinator: Danone Global Research & Innovation Center B.V.

Conditions Disease Related Malnutrition