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 Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-03-17

Study Completion Date

2027-07-31

Brief Summary

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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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Detailed Description

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Conditions

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Disease Related Malnutrition

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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

Test Product

Group Type EXPERIMENTAL

Test Product: Plant based high energy high protein ONS

Intervention Type DIETARY_SUPPLEMENT

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

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

Control Product

Group Type ACTIVE_COMPARATOR

Control Product: Dairy based high energy high protein ONS

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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Test Product: Plant based high energy high protein ONS

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

Intervention Type DIETARY_SUPPLEMENT

Control Product: Dairy based high energy high protein ONS

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

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

1. MUST score ≥ 1 and / or
2. 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
3. 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.
4. Medically and physically able to consume high energy high protein ONS in the opinion of the Investigator.
5. Willing to maintain dietary habits for the duration of the study.
6. Willing to consume plant based as well as dairy based ONS

Exclusion Criteria

1. 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).
2. 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.
3. Any contraindication to oral feeding per se, including gastrointestinal failure or suppressed gastrointestinal function, complete intestinal obstruction and major intraabdominal sepsis.
4. 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).
5. Requiring a protein restricted diet as confirmed by a physician, for example chronic kidney disease stage 4 and 5 (estimated by Glomerular Filtration Rate \<30 mL/min/1.73 m2).
6. Requiring enteral nutrition (via tube delivery) or parenteral nutrition.
7. Subjects following a vegan diet.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No