Clinical trial NCT06781619: Effect of Plant Based High Energy High Protein Oral Nutritional Supplement on Nutritional Intake in Patients With or at Risk of Disease Related Malnutrition.
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.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Disease Related Malnutrition
Lead sponsor: Nutricia Research
Sponsor class: INDUSTRY
First posted: 2025-01-17
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.


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.

Primary outcomes:
measure: 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.
timeFrame: 11 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Mechelen
country: Belgium
facility: Meclinas
Study officials:
References: