NCT06826105

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 3, 2025

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 13, 2025

Completed
7 months until next milestone

Study Start

First participant enrolled

September 22, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2026

Completed
Last Updated

September 30, 2025

Status Verified

September 1, 2025

Enrollment Period

3 months

First QC Date

February 3, 2025

Last Update Submit

September 24, 2025

Conditions

Malnutrition

Keywords

PancrelipaseOral nutritional supplements

Outcome Measures

Primary Outcomes (1)

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

    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.

    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)

Secondary Outcomes (7)

  • Incremental area under the curve of essential amino acids (EAAs)

    From ONS consumption over 3 hours postprandial, specifically in 5 time points (T0 ONS consumption and after 30, 60, 120 and 180 minutes)

  • Incremental area under the curve of total amino acids

    From ONS consumption over 3 hours postprandial, specifically in 5 time points (T0 ONS consumption and after 30, 60, 120 and 180 minutes)

  • Incremental area under the curve of free fatty acids

    From ONS consumption over 3 hours postprandial, specifically in 5 time points (T0 ONS consumption and after 30, 60, 120 and 180 minutes)

  • Incremental area under the curve of triglycerides

    From ONS consumption over 3 hours postprandial, specifically in 5 time points (T0 ONS consumption and after 30, 60, 120 and 180 minutes)

  • Water load satiety test (WLST)

    From ONS consumption over 3 hours postprandial, specifically in 5 time points (T0 ONS consumption and after 30, 60, 120 and 180 minutes)

  • +2 more secondary outcomes

Study Arms (2)

Pancrelipase

EXPERIMENTAL

two capsules each containing 15000 USP units of lipase

Drug: Zenpep

Placebo

PLACEBO COMPARATOR

two capsules each containing placebo

Drug: Placebo

Interventions

ZenpepDRUG

two capsules (each containing 15000 USP units of lipase) together with nutritional supplements

Also known as: Pancrelipase
Pancrelipase
PlaceboDRUG

two capsules (containing placebo) together with nutritional supplements

Also known as: lactose monohydrate
Placebo

Eligibility Criteria

Age70 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kantonsspital Aarau

Aarau, 5001, Switzerland

RECRUITING

MeSH Terms

Conditions

Malnutrition

Interventions

Pancrelipase

Condition Hierarchy (Ancestors)

Nutrition DisordersNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

LipaseCarboxylic Ester HydrolasesEsterasesHydrolasesEnzymesEnzymes and CoenzymesPancreatic ExtractsTissue ExtractsComplex Mixtures

Study Officials

  • Philipp Schuetz, Prof. MD

    Kantonsspital Aarau

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Philipp Schuetz, Prof. MD

CONTACT

+41 62 838 68 80philipp.schuetz@ksa.ch

Carla Wunderle

CONTACT

carla.wunderle@ksa.ch

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Prof. MD

Study Record Dates

First Submitted

February 3, 2025

First Posted

February 13, 2025

Study Start

September 22, 2025

Primary Completion

January 1, 2026

Study Completion

January 1, 2026

Last Updated

September 30, 2025

Record last verified: 2025-09

Locations

CH(1)