| 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
|
|
|
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
|
|
|
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. |