| 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
|
|
|
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
|
|
|
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
|
|
|
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. |