Effect of Low Dose Pancrelipase With an Oral Nutritional Supplement to Improve Nutrient Bioavailability in Patients at Increased Risk of Malnutrition
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Incremental area under the curve of total branched-chained amino acid concentration
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 70 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Pancrelipase
two capsules each containing 15000 USP units of lipase
干预措施: Zenpep (Drug)
Placebo
two capsules each containing placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Incremental area under the curve of total branched-chained amino acid concentration
时间窗: 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.
次要结局
- 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))
- Exploratory subgroup analysis(After study completion, within 1 year)
- Incremental area under the curve of glucose(From ONS consumption over 3 hours postprandial, specifically in 5 time points (T0 ONS consumption and after 30, 60, 120 and 180 minutes))