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NCT Number: 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.

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Meclinas, Mechelen, Belgium

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥ 18 years
  • Identified as at medium or high risk of malnutrition based on:
  • MUST score ≥ 1 and / or
  • 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
  • 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.
  • Medically and physically able to consume high energy high protein ONS in the opinion of the Investigator.
  • Willing to maintain dietary habits for the duration of the study.
  • Willing to consume plant based as well as dairy based ONS

Exclusion criteria

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

Treatment and study plan

Test Product: Plant based high energy high protein ONS

Dietary Supplement

Plant based high energy high protein ONS 2 servings/day for a period of 8 weeks.

Control Product: Dairy based high energy high protein ONS

Dietary Supplement

Dairy based high energy high protein ONS 2 servings equivalent in energy & protein for a period of 8 weeks.

Primary outcomes

  1. 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.

    Time frame: 11 weeks

    Mean total protein intake and mean total energy intake in subject with or at risk of Disease Related malnutrition (DRM) and/or prescribed with ONS will be measured by 3-day nutritional intake diary at baseline, at week 4 and week 8.

Study contacts

Contact information is provided by the study sponsor or research team.

Danone Global Research & Innovation Center B.V.

CONTACT

[email protected]

+31 30 2095 000

Sponsors and collaborators

Lead sponsor

Nutricia Research

Industry

Registry information

Acronym: PRO-PLANT

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Jan 17, 2025
Registry last updated
Sep 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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