Effect of a low-dose enzyme together with a dietary supplement on nutrient absorption in patients at risk of malnutrition.

Switzerland (ICTRP)

ICTRP Trial ID
NCT06826105 (ICTRP)

Official title (approved by ethics committee)
Effect of low dose pancrelipase with an oral nutritional supplement to improve nutrient bioavailability in patients at increased risk of malnutrition (BASEC)

Academic title
Effect of Low Dose Pancrelipase With an Oral Nutritional Supplement to Improve Nutrient Bioavailability in Patients at Increased Risk of Malnutrition (ICTRP)

Public title
Pancrelipase With Nutritional Supplement in Patients at Risk of Malnutrition (EFFORT-ENZO) (ICTRP)

Disease under investigation

Malnutrition

(ICTRP)

Intervention under investigation

Drug: ZenpepDrug: Placebo

(ICTRP)

Type of trial
Interventional (ICTRP)

Trial design

Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).

(ICTRP)

Inclusion/Exclusion criteria

Inclusion Criteria:

• Informed Consent as documented by signature
• Male or female 70 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

(ICTRP)

not available

Primary and secondary end points

Incremental area under the curve of total branched-chained amino acid concentration

(ICTRP)

Incremental area under the curve of essential amino acids (EAAs);Incremental area under the curve of total amino acids;Incremental area under the curve of free fatty acids;Incremental area under the curve of triglycerides;Water load satiety test (WLST);Exploratory subgroup analysis;Incremental area under the curve of glucose

(ICTRP)

Registration date
not available

Incorporation of the first participant
not available

Secondary sponsors
not available

Additional contacts
Philipp Schuetz, Prof. MDPhilipp Schuetz, Prof. MDPhilipp Schuetz, Prof. MD, philipp.schuetz@ksa.chphilipp.schuetz@ksa.ch, +41 62 838 68 80+41 62 838 68 80, Kantonsspital Aarau (ICTRP)

Secondary trial IDs
2024-02519, ka24Schuetz (ICTRP)

Results-Individual Participant Data (IPD)
not available

Further information on the trial
https://clinicaltrials.gov/ct2/show/NCT06826105 (ICTRP)