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临床试验/CTRI/2025/10/096725
CTRI/2025/10/096725尚未招募不适用

An Observational Prescription event monitoring Study to assess the effectiveness of whey peptide in malnourished hospitalized patients

Nucgnex Lifesciences Pvt Ltd1 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2025年11月10日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
25
试验地点
1
主要终点
change in Weight, BMI, MUAC, SGA score at different intervals

研究概览

简要总结

On admission, around 50% of patients have malnutrition, and many more acquire it while in the hospital. Undernutrition or overnutrition that results in altered body composition and impaired function is referred to as malnutrition. 2. Undernutrition resulting from either decreased intake or elevated metabolic rate is usually linked to malnutrition in hospitalized patients. Higher mortality, a worsened discharge functional status, an increased risk of nosocomial infections, longer hospital stays, and higher hospital expenses have all been linked to malnutrition. Reduced capacity to chew or swallow food, low appetite, and nil per os (NPO) status are some of the causes of decreased intake. Due to the consequences of the inflammatory condition, patients with acute or chronic illnesses may either be malnourished at arrival or develop malnutrition within a few days of admission to the hospital.

Prescription-only oral nutritional supplements (ONSs) are specialized liquids, semisolids, or powders that include macro- and micronutrients. Although ONSs should receive guidance on maximizing their use, this component may differ. ONSs are widely utilized in clinical practice to assist individuals who have been diagnosed as malnourished or at risk of becoming malnourished.4 Several components are employed in ONS. With so many different enteral formulae (polymeric, semi-elemental, and elemental) on the market, selecting the best one for a patient might be difficult. Standard formulas are usually well tolerated by patients and are less costly. On the other hand, there are situations where an elemental, semi-elemental, or modular answer may be more suited than an ordinary formula. Semi-elemental formulations contain peptides with different chain lengths and fat content, primarily in the form of MCT. Diets that are semi-elemental cost slightly more than diets that are polymeric, which consist of intact protein, long-chain triglycerides, and complex carbohydrates. However, in terms of tolerance and absorption, patients react more favorably to semi-elemental diets.

As a result, we carried out an observational study to assess the impact of oral nutritional supplements (ONS) based on whey peptide in hospitalized malnourished patients.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 80.00 Year(s)(—)
性别
All

入选标准

  • All the hemodynamically stable hospitalized patients in IPD In patient department with function GI train whom the investigator decides Subject patients should not have any Gastrointestinal Obstructions Patients more than or equal to 18 years old patients who are expected to require nutritional support for 1 week or more.

排除标准

  • Hemodynamically unstable patients requiring vasopressors or critical care support Patients with gastrointestinal obstruction ileus or severe malabsorption disorders Severe hepatic or renal dysfunction eg hepatic failure Patients with known allergy or intolerance to whey protein or milk-derived products Patients on exclusive parenteral nutrition or where enteral oral feeding is contraindicated.
  • Pregnant or lactating women.
  • Patients with advanced malignancy or end of life palliative care where nutrition goals differ.
  • Patients unwilling or unable to provide informed consent.

结局指标

主要结局

change in Weight, BMI, MUAC, SGA score at different intervals

时间窗: Screening/Baseline and post intervention

次要结局

  • CRP albumin handgrip GI tolerance length of stay complications(Screening Baseline & post intervention)

研究者

发起方
Nucgnex Lifesciences Pvt Ltd
申办方类型
Pharmaceutical industry-Indian
责任方
Principal Investigator
主要研究者

Dr Indraneel Basu

7 Med Hospital

研究点 (1)

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