Plant-based versus animal-based oral nutritional supplements
PlAnt Vs Animal Based Oral Nutritional Supplements: Patients' Opinions and Nutritional Outcomes: A Multicenter Pilot Feasibility Study
NA · Radboud University Medical Center · NCT07399886
We're testing whether plant-based nutrition drinks work as well as animal-based drinks for hospitalized adults at high risk of malnutrition.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Radboud University Medical Center (other) |
| Locations | 2 sites (Nijmegen, Gelderland and 1 other locations) |
| Trial ID | NCT07399886 on ClinicalTrials.gov |
What this trial studies
Hospitalized adult patients at two Dutch university medical centers will receive one of two oral nutritional supplements (a plant-based Fresubin vanilla or an animal-based Fresubin Yodrink raspberry) and be followed for three months. Baseline and three-month measurements include weight, height, body composition by bioelectrical impedance (BIA), muscle thickness by lumify ultrasound, handgrip strength, SPPB and TUG physical performance tests, quality-of-life and dietary questionnaires, and a 3-day food diary. Participants will log daily ONS intake, be contacted at one and two months to review intake and any changes, and complete an interview after three months about their experiences. The trial focuses on feasibility and physiological and functional nutrition outcomes in usual-care inpatient settings among patients advised to take at least two ONS bottles daily.
Who should consider this trial
Good fit: Hospitalized adults (≥18 years) treated at Radboudumc or Maastricht UMC+ who are judged at high risk of malnutrition and advised to take at least two bottles of ONS daily are the intended participants.
Not a fit: Patients who are tube- or parenteral-nutrition-dependent, receiving only palliative care, lactose- or soy-intolerant, strictly vegan, unable to follow study procedures, or who used ONS in the prior six months are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If plant-based ONS perform similarly to animal-based ONS, patients could receive comparable nutrition while allowing hospitals to offer more sustainable, lower-carbon nutrition options.
How similar studies have performed: Direct head-to-head comparisons of plant- versus animal-based ONS in hospitalized patients are limited, so evidence for equivalent clinical benefit is still sparse.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Clinical patients with cancer and lung diseases, cardiology patients, patients with cardiothoracic surgery, and orthopaedic patients age ≥18 years, and treated at Radboudumc or Maastricht UMC+. * Patients who have been advised at least 2 bottles of ONS daily based on a high risk of malnutrition (MUST≥2, PG-SGA-SF≥ 9) and/or by the dietitians expertise. * Written informed consent (IC) Exclusion Criteria: * Patients who are or become dependent on tube or parenteral nutrition * Patients where life-extending therapy is no longer possible * Unable to follow up study instructions * Lactose intolerance * Soy allergy/intolerance * Vegan diet * Patients who have used ONS in the past six months
Where this trial is running
Nijmegen, Gelderland and 1 other locations
- Radboud university medical center — Nijmegen, Gelderland, Netherlands (RECRUITING)
- Maastricht University Medical Center — Maastricht, Limburg, Netherlands (RECRUITING)
Study contacts
- Principal investigator: Maud Reintjes, MSc — Radboud University Medical Center
- Study coordinator: Manon van den Berg, PhD
- Email: manon.vandenberg@radboudumc.nl
- Phone: +31 6 12 44 00 88
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Risk of Malnutrition, plant-based ONS, animal-based ONS, Risk of malnutrition, pilot feasibility, hospitalized patients, oral nutritional drinks, plant protein