MalnutritionNCT06826105
Pancrelipase With Nutritional Supplement in Patients at Risk of Malnutrition (EFFORT-ENZO)
A study testing Zenpep in people with Malnutrition, run by Philipp Schuetz at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Malnutrition
- What is being tested?
- Zenpep
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteSwitzerland
- Study dates
- 22 Sep 2025to Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Carla Wunderle contact
Switzerland1 site, 1 recruiting
- Recruiting
Kantonsspital Aarau
Aarau, 5001
Philipp Schuetz, Prof. MD, +41 62 838 68 80, philipp.schuetz@ksa.ch
About this study
Official title: Effect of Low Dose Pancrelipase With an Oral Nutritional Supplement to Improve Nutrient Bioavailability in Patients at Increased Risk of Malnutrition
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.
Read the detailed description
This study investigates whether adding digestive pancreatic enzymes to oral nutritional supplements (ONS) can improve nutrient absorption in older adults at risk of malnutrition. While ONS are commonly recommended, their effectiveness is often limited due to age-related declines in exocrine pancreatic function, leading to reduced enzyme secretion. Studies indicate that pancreatic lipase levels decline with age, potentially impairing nutrient digestion and absorption.
The study proposes using pancrelipase (Zenpep®), an FDA-approved pancreatic enzyme replacement therapy, to enhance nutrient bioavailability. The randomized, placebo-controlled trial will assess whether pancrelipase improves postprandial levels of amino acids, fatty acids, and glucose in hospitalized patients at nutritional risk.
The study aims to determine if pancreatic enzyme supplementation can enhance nutrient absorption and provide a novel strategy for managing malnutrition in older adults without diagnosed exocrine pancreatic insufficiency (EPI). If successful, this approach could improve clinical outcomes, reduce healthcare costs, and enhance quality of life.
- Conditions
- Malnutrition
- Being tested
- Zenpep, Placebo
- Keywords
- Pancrelipase, Oral nutritional supplements
- Medical subject headings
- Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZenpepDrug
Also called Pancrelipase
two capsules (each containing 15000 USP units of lipase) together with nutritional supplements
PlaceboDrug
Also called lactose monohydrate
two capsules (containing placebo) together with nutritional supplements
| Study group | Role | What they receive |
|---|---|---|
| Pancrelipase | Experimental | two capsules each containing 15000 USP units of lipase Receives: Drug: Zenpep |
| Placebo | Placebo comparator | two capsules each containing placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
Evaluation of the incremental area under the curve (iAUC) of essential amino acids (EAAs) in plasma, expressed in micromoles per liter (μmol/L). The iAUC reflects the time-dependent changes in EAAs concentrations and is used to assess metabolic responses.
Measured: 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
Evaluation of the incremental area under the curve (iAUC) of total amino acids in plasma, expressed in micromoles per liter (μmol/L). The iAUC reflects the time-dependent changes in total amino acid concentrations and is used to assess metabolic responses.
Measured: 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
Evaluation of the incremental area under the curve (iAUC) of free fatty acids in plasma, expressed in micromoles per liter (μmol/L). The iAUC reflects the time-dependent changes in free fatty acid concentrations and is used to assess metabolic responses.
Measured: 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
Evaluation of the incremental area under the curve (iAUC) of triglycerides in plasma, expressed in millimoles per liter (mmol/L). The iAUC reflects the time-dependent changes in triglycerides concentrations and is used to assess metabolic responses.
Measured: 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)
Values of a modified water load satiety test (WLST), a questionnaire of 5 sub-scores on a scale of 1-100. We will report both the sum of the scores and the 5 individual sub scales will be reported. Participant rate pre-and postprandial intensity of symptoms for fullness, hunger, abdominal discomfort, bloating, and nausea on a 0-100 mm visual analogue scale where 0 is none, and 100 is severe
Measured: From ONS consumption over 3 hours postprandial, specifically in 5 time points (T0 ONS consumption and after 30, 60, 120 and 180 minutes)
Exploratory subgroup analysis
Exploratory subgroup analyses to test their effect on the primary outcome (incremental area under the curve (AUC) of total branched-chained amino acid concentration in the blood) will be performed. These will be assessed using a t-test on the differences between pancrelipase and placebo for each patient. Groups are based on the subgroup including median age [years], malnutrition risk [Nutritional Risk Screening 2002 total score], median weight [kg], sex [male/female], prior history of gastrointestinal side effects [yes/no], median fecal elastase [μg/g]
Measured: After study completion, within 1 year
Incremental area under the curve of glucose
Evaluation of the incremental area under the curve (iAUC) of glucose in plasma, expressed in millimoles per liter (mmol/L). The iAUC reflects the time-dependent changes in glucose concentrations and is used to assess metabolic responses.
Measured: From ONS consumption over 3 hours postprandial, specifically in 5 time points (T0 ONS consumption and after 30, 60, 120 and 180 minutes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2025
- Study start22 Sep 2025
- Primary completionJan 2027 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MalnutritionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Philipp Schuetz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Philipp Schuetz, Kantonsspital Aarau
- Investigators
- Philipp Schuetz, Prof. MD, Principal investigator, Kantonsspital Aarau
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06826105
- Sponsor's protocol ID
- 2024-02519; ka24Schuetz
- Status last verified
- Sep 2025
- First submitted
- 3 Feb 2025
- Last updated
- 22 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Low Dose Pancrelipase With an Oral Nutritional Supplement to Improve Nutrient Bioavailability in Patients at Increased Risk of Malnutrition
- ClinicalTrials.gov ID
- NCT06826105
- Acronym / sponsor ID
- 2024-02519; ka24Schuetz
- Conditions
- Malnutrition
- Keywords
- Pancrelipase, Oral nutritional supplements
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Philipp SchuetzUniversity, hospital or other
- Study start
- 22 Sep 2025 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 13 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study investigates whether adding digestive pancreatic enzymes to oral nutritional supplements (ONS) can improve nutrient absorption in older adults at risk of malnutrition. While ONS are commonly recommended, their effectiveness is often limited due to age-related declines in exocrine pancreatic function, leading to reduced enzyme secretion. Studies indicate that pancreatic lipase levels decline with age, potentially impairing nutrient digestion and absorption.
The study proposes using pancrelipase (Zenpep®), an FDA-approved pancreatic enzyme replacement therapy, to enhance nutrient bioavailability. The randomized, placebo-controlled trial will assess whether pancrelipase improves postprandial levels of amino acids, fatty acids, and glucose in hospitalized patients at nutritional risk.
The study aims to determine if pancreatic enzyme supplementation can enhance nutrient absorption and provide a novel strategy for managing malnutrition in older adults without diagnosed exocrine pancreatic insufficiency (EPI). If successful, this approach could improve clinical outcomes, reduce healthcare costs, and enhance quality of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pancrelipase | Experimental | Drug: Zenpeptwo capsules each containing 15000 USP units of lipase |
| Placebo | Placebo comparator | Drug: Placebotwo capsules each containing placebo |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ZenpepAlso: Pancrelipasetwo capsules (each containing 15000 USP units of lipase) together with nutritional supplements | Drug | Pancrelipase |
| PlaceboAlso: lactose monohydratetwo capsules (containing placebo) together with nutritional supplements | Drug | Placebo |
Primary outcome
Incremental area under the curve of total branched-chained amino acid concentration
Time frame: 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.
7 secondary outcomes
Incremental area under the curve of essential amino acids (EAAs)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: From ONS consumption over 3 hours postprandial, specifically in 5 time points (T0 ONS consumption and after 30, 60, 120 and 180 minutes)
Exploratory subgroup analysis
Time frame: After study completion, within 1 year
Incremental area under the curve of glucose
Time frame: From ONS consumption over 3 hours postprandial, specifically in 5 time points (T0 ONS consumption and after 30, 60, 120 and 180 minutes)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Carla Wunderle contact
Philipp Schuetz, Prof. MD principal investigator
Kantonsspital Aarau
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Zenpep in people with Malnutrition, run by Philipp Schuetz at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Philipp Schuetz, Prof. MD (+41 62 838 68 80, philipp.schuetz@ksa.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incremental area under the curve of total branched-chained amino acid concentration (time frame: 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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2026.