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

Study acronym: PRO-PLANT
StatusCompleted
PhaseNot applicable
Started

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Record History

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  1. Primary endpoints: details revised at 1 of 1 entry Show 5 more changesShow less
    • Trial completed
    • Study completion date changed from estimate of Jul 2027 to Sep 8, 2026
    • Enrollment target: estimated 80 to confirmed 76
    • Eligibility criteria expanded, about 15 words
    • Site details revised at 2 of 2 sites
  2. Study sites: 1 to 2v3
  3. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of Feb 2025 to Mar 17, 2025
    v2
  4. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06781619
Lead Sponsor Nutricia Research
Conditions
(from sponsor)		 Disease Related Malnutrition
Enrollment 76 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov