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New treatment option for Disease Related Malnutrition
Official title Effect of Plant Based High Energy High Protein Oral Nutritional Supplement on Nutritional Intake in Patients With or at Risk of Disease Related Malnutrition.
ClinicalTrials.gov ID: NCT06781619
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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.
You likely can't join if
- 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...
- Known intolerance to any ingredients as listed in the study product composition (refer to PIB and appendix of this protocol). people with lactose...
- Any contraindication to oral feeding per se, including gastrointestinal failure or suppressed gastrointestinal function, complete intestinal...
- Active flare of inflammatory bowel disease as defined by Harvey-Bradshaw Index (HBI) \>6 (Crohn's disease) or Simple Clinical Colitis Activity Index...
- Requiring a protein restricted diet as confirmed by a physician, for example chronic kidney disease stage 4 and 5 (estimated by Glomerular Filtration...
- Requiring enteral nutrition (via tube delivery) or parenteral nutrition.
See the full eligibility criteria
- 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
- 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). people 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).
- 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).
- Requiring enteral nutrition (via tube delivery) or parenteral nutrition.
- people following a vegan diet.
The study team makes the final eligibility decision.
Where it's taking place
- Mechelen, Belgium
- Rotterdam, Netherlands
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Mechelen, Belgium; Rotterdam, Netherlands. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.