Effect of Plant Based High Energy High Protein Oral Nutritional Supplement on Nutritional Intake … (NCT06781619) | Clinical Trial Compass
RecruitingNot Applicable
Effect of Plant Based High Energy High Protein Oral Nutritional Supplement on Nutritional Intake in Patients With or at Risk of Disease Related Malnutrition.
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
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.
. Willing to consume plant based as well as dairy based ONS
Exclusion criteria
. 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).
. 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.