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CTRI Number  CTRI/2025/12/099643 [Registered on: 22/12/2025] Trial Registered Prospectively
Last Modified On: 20/03/2026
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Nutraceutical 
Study Design  Single Arm Study 
Public Title of Study   Health benefits of Nutraceutical supplementation in older adults. 
Scientific Title of Study   A proof-of-concept clinical study to evaluate the impact of a combination nutraceutical kit on muscle function, cognitive performance, and immune resilience in older adults. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
GP/CT/25-26/001 Version: 1.00 dated 19th November 2025  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Ram Mundhe 
Designation  Principal Investigator 
Affiliation  Gunjkar Multispeciality Hospital  
Address  Gunjkar Multispeciality Hospital, Plot No 315, Sector No 18,Spine Road,Chinchwad,
-
Pune
MAHARASHTRA
411062
India 
Phone  8454859082  
Fax  -  
Email  drrammudhe.gunjkarresearch@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Shridhar Pandya 
Designation  Director 
Affiliation  GPLIFE HEALTHCARE PRIVATE LIMITED 
Address  Office no. 705-706, 7th floor, Orbit 1 Building, near RRTM Market, Punagam Saroli Road,
-
Surat
GUJARAT
395010
India 
Phone  9824917109  
Fax  -  
Email  gplifehealthcare@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Shridhar Pandya 
Designation  Director 
Affiliation  GPLIFE HEALTHCARE PRIVATE LIMITED 
Address  Office no. 705-706, 7th floor, Orbit 1 Building, near RRTM Market, Punagam Saroli Road,
-
Surat
GUJARAT
395010
India 
Phone  9824917109  
Fax  -  
Email  gplifehealthcare@gmail.com  
 
Source of Monetary or Material Support  
GPLIFE HEALTHCARE PRIVATE LIMITED 
 
Primary Sponsor  
Name  GPLIFE HEALTHCARE PRIVATE LIMITED 
Address  Office no. 705-706, 7th floor, Orbit 1 Building, near RRTM Market, Punagam Saroli Road, Surat, Gujarat 395010 
Type of Sponsor  Other [Nutraceutical Company] 
 
Details of Secondary Sponsor  
Name  Address 
Dr Chetan Savaliya   GPLIFE HEALTHCARE PRIVATE LIMITED, Office no. 705-706, 7th floor, Orbit 1 Building, near RRTM Market, Punagam Saroli Road, Surat, Gujarat 395010 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Ram Mundhe  Gunjkar Multispeciality Hospital  Gunjkar Multispeciality Hospital, OPD NO. 1 Ground Floor ,Plot No. 315, Sector No. 18, Spine Road, Chinchwad,
Pune
MAHARASHTRA 		 8454859082
-
drrammudhe.gunjkarresearch@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Sangvi Multispeciality Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Older Adults  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NOT Applicable  - 
Intervention  Powder containing whey isolate and herbal extracts (30g sachet)  Mix with water and consume twice daily before meals. 
 
Inclusion Criteria  
Age From  50.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  1.Participants with-
i)Generally good health with life expectance greater than equal to 5 years.
ii)Male and female participants aged between 50 to 80 years having a BMI between 25 to 35 kg per meter Square.
iii)Health not severely compromised that is no life threatening illness or disability.
2.Participants with-
i)Intrinsic Capacity score showing mild to moderate decline and
ii)Short Physical Performance Battery SPPB score between 9 to 11 and
iii)Montreal Cognitive Assessment (MoCA) greater than 20 and less than equal to 25.
3.Participants with or without comorbidity. If comorbidity is present, it should be on a stable regimen that is same drug and same dose for at least 12 weeks before the screening visit.
4.Participants are able and willing to provide written informed consent, comply with the study protocol requirements, and can read and write in English.  
 
ExclusionCriteria 
Details  1.Severe or uncontrolled chronic disease osteoarthritis, advanced cardiovascular disease, kidney failure, uncontrolled diabetes, severe COPD, terminal cancer.
2.Physical disability requiring a walker or wheelchair.
3.Diagnosed dementia or cognitive impairment preventing protocol compliance.
4.Acute infection or illness within 3 months before enrollment.
5.Unstable medical conditions example recent MI, unstable angina, uncontrolled hypertension.
6.Major surgery in the past 6 months or planned during study.
7.Severe psychiatric disorders unless well controlled.
8.Substance abuse within past 6 months.
9.Participation in another clinical trial within the last 6 months.
10.Known allergy to any component of the nutraceutical kit.
11.Participants with sedentary lifestyles are not able or not advised to undergo the resistance training as per protocol.
12.Any clinically relevant macro or micro-nutrient deficiency as per investigator discretion.
13.Pregnant women, lactating women, women of child bearing potential not following adequate contraceptive measures, women who were found positive for urine pregnancy test.
14.Participants who are currently taking any herbal products, nutraceuticals, Ayurvedic formulations, dietary supplements, or vitamin or mineral supplements and are unwilling to discontinue their use for the duration of the study.
15.According to the investigator, any other illness or abnormal laboratory investigations would interfere directly with the study results or jeopardize the participants health. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1.Evaluate the impact of the combination nutraceutical kit on muscle function, including strength, endurance, and muscle mass.
2.Assess effects on cognitive performance, including executive function, memory, and processing speed.
3.Evaluate immune resilience and inflammation modulation through relevant immune biomarkers and immune cell measurements.
 		 1.At Screening And day 60.
2.At Screening And day 60.
3.At Screening And day 60. 
 
Secondary Outcome  
Outcome  TimePoints 
1.Evaluation of longevity biomarkers and Putative Energy markers.
2.Assessment of anthropometric parameters,hematological,biochemical investigation.
3.Adverse events profile
4.Compliance and tolerability of the investigational product.
 		 1.At Screening And Day 60.
2.At Screening And Day 60.
3.from baseline to end of the study.
4.from baseline to end of the study. 
 
Target Sample Size   Total Sample Size="23"
Sample Size from India="23" 
Final Enrollment numbers achieved (Total)= "24"
Final Enrollment numbers achieved (India)="24" 
Phase of Trial   Post Marketing Surveillance 
Date of First Enrollment (India)   30/12/2025 
Date of Study Completion (India) 02/03/2026 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Completed 
Recruitment Status of Trial (India)  Completed 
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   This study examines a multi-ingredient nutraceutical designed to support several areas of health in older adults, including muscle strength, cognitive function, immune response, and inflammation. Unlike single-drug treatments, the ingredients work together through complementary mechanisms across different biological systems. Since this combined approach has not been clinically tested before, the trial will provide early evidence on functional outcomes and biomarker changes. The main goal is to measure improvements in muscle performance, while secondary goals include evaluating effects on cognition, immunity, inflammation, safety, and tolerability in older adults. 
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