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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorNutricia Research

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥ 18 years

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.

Disqualifiers

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).

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.

Any contraindication to oral feeding per se, including gastrointestinal failure or suppressed gastrointestinal function, complete intestinal obstruction and major intraabdominal sepsis.

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).

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • 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.

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: Plant Based High Energy High Protein (PB HEHP) Oral Nutrition Supplement (ONS)Experimental treatment 1 intervention
Group B: Diary Based High Energy High Protein (DB HEHP) Oral Nutrition Supplement (ONS)Active comparator 1 intervention

Trial outcomes

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.

Time frame
11 weeks

Secondary outcomes

Other outcomes

Sponsors and contacts

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