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

Launched by NUTRICIA RESEARCH · Jan 13, 2025

Keywords

ClinConnect Summary

This clinical trial is studying how a plant-based, high-energy, high-protein nutritional supplement can help patients who are at risk of malnutrition. The goal is to see if using this supplement twice a day for 8 weeks can improve nutritional intake in these patients. To qualify for the study, participants need to be at least 18 years old and have been identified as being at medium or high risk of malnutrition based on specific guidelines. They should also be able to consume two servings of the supplement each day for the duration of the trial.

If you decide to participate, you'll start by taking the supplement in the morning and again in the afternoon or evening for 8 weeks. The study lasts about 11 weeks in total, including a brief screening period and a follow-up call after the supplement phase. It's important to note that participants cannot have certain allergies or conditions that would make it unsafe for them to take the supplement. Overall, this study aims to find out if this nutritional supplement can help improve the health and nutrition of individuals at risk of malnutrition.

Gender

ALL

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.