Pancrelipase With Nutritional Supplement in Patients at Risk of Malnutrition (EFFORT-ENZO)
ConditionMalnutrition
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age60+
SponsorPhilipp Schuetz
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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.
Trial design
Design model
Crossover
Treatments tested in this trial
Zenpep
Drugtwo capsules (each containing 15000 USP units of lipase) together with nutritional supplements
Placebo
Drugtwo capsules (containing placebo) together with nutritional supplements
Treatment groups
20 Participants
are divided into 2 treatment groupsGroup A: PancrelipaseExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
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.
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)Secondary outcomes
1
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.
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)2
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.
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)3
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.
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)4
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.
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)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Philipp Schuetz
Lead sponsor
Kantonsspital Aarau
Sponsor institution
Source ClinicalTrials.gov