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

Last updated: April 23, 2025
Sponsor: Nutricia Research
Overall Status: Active - Recruiting

Phase

N/A

Condition

Weight Loss

Diet And Nutrition

Treatment

Test Product: Plant based high energy high protein ONS

Control Product: Dairy based high energy high protein ONS

Clinical Study ID

NCT06781619
23REX0061267
  • Ages > 18
  • All Genders

Study 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

Inclusion Criteria:

  1. Age ≥ 18 years

  2. Identified as at medium or high risk of malnutrition based on:

  3. MUST score ≥ 1 and / or

  4. Being prescribed with ONS and willing and able to switch from pre-studyprescribed ONS to the Test or Control Product for participation in the study

  5. 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.

  6. Medically and physically able to consume high energy high protein ONS in the opinionof the Investigator.

  7. Willing to maintain dietary habits for the duration of the study.

  8. Willing to consume plant based as well as dairy based ONS

Exclusion

Exclusion Criteria:

  1. Known allergy to soy, cow's milk protein or to any other ingredients as listed inthe study product composition (refer to the product information brochure (PIB) andthe 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 whouse lactase may still be enrolled in the study.

  3. Any contraindication to oral feeding per se, including gastrointestinal failure orsuppressed gastrointestinal function, complete intestinal obstruction and majorintraabdominal 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 chronickidney disease stage 4 and 5 (estimated by Glomerular Filtration Rate <30mL/min/1.73 m2).

  6. Requiring enteral nutrition (via tube delivery) or parenteral nutrition.

  7. Subjects following a vegan diet.

Study Design

Total Participants: 80
Treatment Group(s): 2
Primary Treatment: Test Product: Plant based high energy high protein ONS
Phase:
Study Start date:
March 17, 2025
Estimated Completion Date:
July 31, 2027

Connect with a study center

  • Meclinas

    Mechelen, 2800
    Belgium

    Active - Recruiting

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