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CTRI Number  CTRI/2025/10/096725 [Registered on: 31/10/2025] Trial Registered Prospectively
Last Modified On: 01/11/2025
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Follow Up Study 
Study Design  Single Arm Study 
Public Title of Study   Improving Nutrition in Weak Hospitalized Patients Using Whey Peptide Supplements 
Scientific Title of Study   An Observational Prescription event monitoring Study to assess the effectiveness of whey peptide in malnourished hospitalized patients 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Indraneel Basu 
Designation  Principal Investigator 
Affiliation  7 Med Hospital 
Address  7Med Hospital Department- Medicine Room No. 106 Badshah Bagh Colony Fatman Rd Maldahiya Chetganj Varanasi Uttar Pradesh

Varanasi
UTTAR PRADESH
221002
India 
Phone  9140291596  
Fax    
Email  dribasumd@yahoo.co.in  
 
Details of Contact Person
Scientific Query
 
Name  Jay Singh 
Designation  SMO Head 
Affiliation  Analysis Research Management Services 
Address  Department- Research Room No.= 213 Newada BHU DLW Road Varanasi

Varanasi
UTTAR PRADESH
221004
India 
Phone  9450282031  
Fax    
Email  singhjai82@gmail.com   
 
Details of Contact Person
Public Query
 
Name  Jay Singh 
Designation  SMO Head 
Affiliation  Analysis Research Management Services 
Address  Department- Research Room No.- 213 Newada BHU DLW Road Varanasi

Varanasi
UTTAR PRADESH
221004
India 
Phone  9450282031  
Fax    
Email  singhjai82@gmail.com   
 
Source of Monetary or Material Support  
7Med Hospital, C-19/15-B 10RR, Badshah Bagh Colony, Fatman Rd, Badshahbag Colony, Maldahiya, Chetganj, Varanasi, Uttar Pradesh- 221002 
 
Primary Sponsor  
Name  Nucgnex Lifesciences Pvt Ltd 
Address  First floor 101 Ectasy C Wing Near City Pride Kothrud Pune Maharashtra India- 411029  
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Jay Singh  7 Med Hospital  Room No.- 106 Department- Research Division- Medicine Badshah Bagh Colony Fatman Rd Badshahbag Colony Maldahiya Chetganj Varanasi Uttar Pradesh- 221002
Varanasi
UTTAR PRADESH 
9450282031

singhjai82@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Independent EC Namaste Integrated Services  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E440||Moderate protein-calorie malnutrition,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  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
 
 
ExclusionCriteria 
Details  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. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
change in Weight, BMI, MUAC, SGA score at different intervals   Screening/Baseline and post intervention 
 
Secondary Outcome  
Outcome  TimePoints 
CRP albumin handgrip GI tolerance length of stay complications  Screening Baseline & post intervention 
 
Target Sample Size   Total Sample Size="25"
Sample Size from India="25" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   10/11/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="2"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

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.

 
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