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

Nutricia

Status: Enrolling

Conditions: Disease Related Malnutrition

Treatments: Dietary Supplement: Test Product: Plant based high energy high protein ONS; Dietary Supplement: Control Product: Dairy based high energy high protein ONS

Study type: Interventional

Funder types: Industry

Identifiers

NCT06781619

23REX0061267

Details and patient eligibility

About

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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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80 participants in 2 patient groups

Plant Based High Energy High Protein (PB HEHP) Oral Nutrition Supplement (ONS)

Experimental group

Description:

Test Product

Treatment:

Dietary Supplement: Test Product: Plant based high energy high protein ONS

Diary Based High Energy High Protein (DB HEHP) Oral Nutrition Supplement (ONS)

Active Comparator group

Description:

Control Product

Treatment:

Dietary Supplement: Control Product: Dairy based high energy high protein ONS