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CTRI Number  CTRI/2022/12/048031 [Registered on: 12/12/2022] Trial Registered Prospectively
Last Modified On: 05/12/2022
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Study on nutrition and age-related muscle loss in an Indian population 
Scientific Title of Study   Characterizing plasma metabolites/ lipids and gut microbiome profile as biomarkers of susceptibility to sarcopenia in the elderly 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Niranjan 
Designation  Consultant, Orthopedics 
Affiliation  Bangalore Baptist Hospital 
Address  Room no.129 Ground floor Department of orthopedics Bangalore Baptist Hospital Bellary Road Hebbal Bangalore

Bangalore
KARNATAKA
560024
India 
Phone  9108016194  
Fax    
Email  onsnir@yahoo.co.in  
 
Details of Contact Person
Scientific Query
 
Name  Dr Aravind Ramnathan 
Designation  Associate professor, Head Research inStem 
Affiliation  Institute for Stem Cell Science and Regenerative Medicine 
Address  room no.201 Regulation of cell fate 2nd floor south wing lab, Institute for Stem Cell Science & Regenerative Medicine GKVK Post Bangalore

Bangalore
KARNATAKA
560065
India 
Phone  9482775648  
Fax    
Email  arvind@instem.res.in  
 
Details of Contact Person
Public Query
 
Name  Dr Aravind Ramnathan 
Designation  Associate professor, Head Research inStem 
Affiliation  Institute for Stem Cell Science and Regenerative Medicine 
Address  room no.201 Regulation of cell fate 2nd floor south wing lab, Institute for Stem Cell Science & Regenerative Medicine GKVK Post Bangalore

Bangalore
KARNATAKA
560065
India 
Phone  9482775648  
Fax    
Email  arvind@instem.res.in  
 
Source of Monetary or Material Support  
Institute for Stem Cell Science and Regenerative Medicine 
 
Primary Sponsor  
Name  Institute for Stem Cell Science and Regenerative Medicine 
Address  Bangalore Life Science Cluster, GKVK Campus, Bellary Rd, Bengaluru, Karnataka 560065 
Type of Sponsor  Research institution 
 
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 
Dr Niranjan  Bangalore Baptist Hospital  Department of orthopaedic ground floor Bangalore Baptist Hospital Bellary road Hebbal
Bangalore
KARNATAKA 
9108016194

onsnir@yahoo.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Review Board Bangalore Baptist Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Age more than 60 years 
Patients  (1) ICD-10 Condition: M625||Muscle wasting and atrophy, not elsewhere classified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  60.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1.Stable health and ability to be independent/ autonomous
2. with grip strength suggesting sarcopenia and MRI showing sarcopenia
3.with long bone fracture requiring immobilisation 
 
ExclusionCriteria 
Details  1. Congenital muscludytrophies
2. Chronic cardiopulmonary insufficiency
3. Severe liver damage (cut-off of transaminase levels) requiring limited protein intake
4. Presence of malignant neoplastic disease (which may cause Cachexia)

 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Quantifying plasma nutrients, IGF-1, IL6, TroponinT, metabolites and lipids from control, sarcopenic and fractured subjects  24hr 
 
Secondary Outcome  
Outcome  TimePoints 
Measuring changes in intestinal microbiota between control, sarcopenic and fractured patients using DNA sequencing of the metagenome.  24hr 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   12/12/2022 
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="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NA 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

Sarcopenia is a major challenge in aging populations as it directly affects mobility, metabolic health, quality of life and increased risk of decline in mental health and numerous diseases of aging such as Type II Diabetes. Targeting sarcopenia is a major target for healthy aging and quicker recovery from hospitalizations in the elderly. However much is not known about sarcopenia in elderly.

 

This study is a collaboration between , Bangalore Baptist Hospital,  Institute for Stem Cell Science and Regenerative Medicine (inStem),  and Vayah Vikas is a registered Public Trust, with an ambition to improve the lives of elderly for enhanced quality and dignified living. The Scope of collaboration on academic and research activities in understanding Nutritional and environmental factors in age related skeletal muscle loss in elderly.

 

 

There is significant association between nutritional cues and ability of human beings to maintain skeletal muscle mass, especially as they age. Nutrients directly or through signalling pathways (e.g. insulin-PI3K, mTOR) alter rates of protein synthesis and turnover, thereby controlling muscle mass and function. In recent years, studies carried out in western populations have pointed out that nutrients such as Vitamin D, antioxidants, branched chain amino acids and polyunsaturated fatty acids can have a positive impact on the progression of sarcopenia along with physical activity. The levels and trajectory of the leves of these nutrients in aged population, in developing nations such as India are not known.  Filling this gap in knowledge will provide new nutritional and metabolic targets for treatment of sarcopenia.

The microbiome has established itself as a major modifier of physiology and health in humans. Recently it has been shown that in both western and Chinese populations there are significant alterations in the composition of the gut microbiome, that correlates with sarcopenia. This offers an exciting possibility that restoring the composition of the microbiome may be able to prevent or manage sarcopenia.

 

There is a need to model sarcopenia in vitro, which will enable rapid and personalized treatments against this disease. It is unclear whether features of sarcopenia can be modelled from patient PBMC derived myoblasts. Dr. Aravind has been studying sarcopenia in mice and the various pathways involved in it.  Through this collaboration we want to explore whether those pathways are expressed in human cells as well.

 

In this study, we are looking at 4 possible groups – elderly with sarcopenia, elderly without sarcopenia, elderly functionally mobile (before fracture) coming to hospital with long bone fracture needing immobilisation and young coming to hospital with long bone fracture needing immobilisation.  We will look at the metabolites in their blood and microbiome in their gut to see any differences in sarcopenia group.

 
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