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)

September 23, 2025 updated by: Nutricia Research
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Plant Based High Energy High Protein (PB HEHP) Oral Nutrition Supplement (ONS)
Test Product
Dietary supplement: Test Product: Plant based high energy high protein ONS
Plant based high energy high protein ONS 2 servings/day for a period of 8 weeks.
Active Comparator: Diary Based High Energy High Protein (DB HEHP) Oral Nutrition Supplement (ONS)
Control Product
Dietary supplement: Control Product: Dairy based high energy high protein ONS
Dairy based high energy high protein ONS 2 servings equivalent in energy & protein for a period of 8 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
11 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nutricia Research

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 17, 2025

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

July 1, 2027

Study Registration Dates

First Submitted

January 6, 2025

First Submitted That Met QC Criteria

January 13, 2025

First Posted (Actual)

January 17, 2025

Study Record Updates

Last Update Posted (Estimated)

September 24, 2025

Last Update Submitted That Met QC Criteria

September 23, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 23REX0061267

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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