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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Plant Based High Energy High Protein (PB HEHP) Oral Nutrition Supplement (ONS) | Experimental | Test Product |
|
| Diary Based High Energy High Protein (DB HEHP) Oral Nutrition Supplement (ONS) | Active Comparator | Control Product |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Test Product: Plant based high energy high protein ONS | Dietary Supplement | Plant based high energy high protein ONS 2 servings/day for a period of 8 weeks. |
|
| 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. | 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 |
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Inclusion Criteria:
Age ≥ 18 years
Identified as at medium or high risk of malnutrition based on:
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
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Danone Global Research & Innovation Center B.V. | Contact | +31 30 2095 000 | register.clinicalresearchnutricia@danone.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Meclinas | Recruiting | Mechelen | 2800 | Belgium |
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| Control Product: Dairy based high energy high protein ONS | Dietary Supplement | Dairy based high energy high protein ONS 2 servings equivalent in energy & protein for a period of 8 weeks. |
|
| QClinical | Recruiting | Rotterdam | Netherlands |
|