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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Dietary supplement
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Belgium
Meclinas
RECRUITING
Mechelen
Netherlands
QClinical
RECRUITING
Rotterdam
Contact Information
Primary
Danone Global Research & Innovation Center B.V.
register.clinicalresearchnutricia@danone.com
+31 30 2095 000
Time Frame
Start Date: 2025-03-17
Estimated Completion Date: 2027-07
Participants
Target number of participants: 80
Treatments
Experimental: Plant Based High Energy High Protein (PB HEHP) Oral Nutrition Supplement (ONS)
Test Product
Active_comparator: Diary Based High Energy High Protein (DB HEHP) Oral Nutrition Supplement (ONS)
Control Product
Related Therapeutic Areas
Sponsors
Leads: Nutricia Research

This content was sourced from clinicaltrials.gov