Trials Sponsors Conditions Drugs Pricing

Conditions

Disease Related Malnutrition

Outcome Measures

Primary Outcomes (1)

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

Study Arms (2)

Plant Based High Energy High Protein (PB HEHP) Oral Nutrition Supplement (ONS)

EXPERIMENTAL

Test Product

Dietary Supplement: Test Product: Plant based high energy high protein ONS

Diary Based High Energy High Protein (DB HEHP) Oral Nutrition Supplement (ONS)

ACTIVE COMPARATOR

Control Product

Dietary Supplement: Control Product: Dairy based high energy high protein ONS

Interventions

Test Product: Plant based high energy high protein ONSDietary supplement

Plant based high energy high protein ONS 2 servings/day for a period of 8 weeks.

Plant Based High Energy High Protein (PB HEHP) Oral Nutrition Supplement (ONS)

Control Product: Dairy based high energy high protein ONSDietary supplement

Dairy based high energy high protein ONS 2 servings equivalent in energy \& protein for a period of 8 weeks.

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Age ≥ 18 years
Identified as at medium or high risk of malnutrition based on:

Sponsors & Collaborators

Nutricia Research
Industrylead

Study Sites (2)

Meclinas

Mechelen, 2800, Belgium

QClinical

Rotterdam, Netherlands

Enrollment

76 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: not applicable
Allocation: RANDOMIZED
Masking: TRIPLE
Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose: SUPPORTIVE CARE
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

January 6, 2025

First Posted

January 17, 2025

Study Start

March 17, 2025

Actual (reported)

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Study Arms (2)

Plant Based High Energy High Protein (PB HEHP) Oral Nutrition Supplement (ONS)

Diary Based High Energy High Protein (DB HEHP) Oral Nutrition Supplement (ONS)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (2)

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Study Arms (2)

Plant Based High Energy High Protein (PB HEHP) Oral Nutrition Supplement (ONS)

Diary Based High Energy High Protein (DB HEHP) Oral Nutrition Supplement (ONS)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (2)

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations