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Plant-Based nutrition drink takes on dairy in malnutrition trial

NCT ID NCT06781619

Disease control Sponsor: Nutricia Research Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 26, 2026 · Updated 2 times

Summary

This study compares a plant-based high-energy, high-protein drink to a dairy-based version in 80 adults who are malnourished or at risk. Participants drink two servings daily for 8 weeks. Researchers track calorie and protein intake to see if the plant-based option works as well as the dairy one.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
plant-based high energy high protein oral nutritional supplement
What this could lead to
If it works, this could offer a plant-based option for improving nutrition in people with or at risk of malnutrition.
What could go wrong
This is a small, early-stage trial (80 people) comparing two supplements, so results may not be definitive or apply to everyone. It does not test a new drug or cure.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 80 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2025

Expected to finish

Jul 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

nutritional deficiency disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Disease related malnutrition

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites in 2 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Meclinas

    RECRUITING

    Mechelen, 2800, Belgium

  • QClinical

    RECRUITING

    Rotterdam, Netherlands

More trials for these conditions

Other studies related to the condition(s) this trial covers.