NCT06826105

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

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Philipp Schuetz · Academic / Other
• Sex: All
• Age: 70 Years
• Healthy volunteers: Not accepted

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.

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

Interventions

Type	Name	Description
DRUG	Zenpep	two capsules (each containing 15000 USP units of lipase) together with nutritional supplements
DRUG	Placebo	two capsules (containing placebo) together with nutritional supplements

Timeline

• Start date: 2025-09-22
• Primary completion: 2026-01-01
• Completion: 2026-01-01
• First posted: 2025-02-13
• Last updated: 2025-09-30

Locations

1 site across 1 country: Switzerland