Zenpep: two capsules (each containing 15000 USP units of lipase) together with nutritional supplements
Placebo: two capsules (containing placebo) together with nutritional supplements
Study summary
This study investigates if pancreatic enzymes in combination with oral nutritional supplement can improve nutrient bioavailability in older people with malnutrition or at risk of malnutrition.
Eligibility
Sex
ALL
Min age
60 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* Informed Consent as documented by signature
* Male or female 60 years of age or older
* Hospitalized at site
* Nutrition Risk Screening 2002 (NRS-2002) ≥ 3
* eGFR ≥ 30 mL/min/1.73 m2 (EPI-CKD) based on medical history (no older than 6 months)
* Ability to eat orally
Exclusion Criteria:
* Patients with acute cardiovascular event ≤ 2 days
* Patients with terminal conditions
* Patients diagnosed with pancreatic exocrine insufficiency (EPI) treated with pancreatic enzyme replacement therapy (PERT)
* Patients having a planned transplant or new-onset dialysis in the next 6 months.
* Patients having a colectomy, resection of the small intestine or cholecystectomy
* Known hypersensitivity to any of the substances or excipients of the ONS or the medicinal product
Primary outcome measure(s)
Incremental area under the curve of total branched-chained amino acid concentration — From oral nutritional supplements (ONS) consumption over 3 hours postprandial, specifically in 5 time points (T0 ONS consumption and after 30, 60, 120 and 180 minutes) Evaluation of the incremental area under the curve (iAUC) of total branched-chain amino acid (BCAA) concentration in blood, including leucine (μmol/L), isoleucine (μmol/L), and valine (μmol/L). The iAUC represents the time-dependent changes in BCAA levels and is used to assess metabolic responses.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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