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CTRI Number  CTRI/2018/12/016777 [Registered on: 24/12/2018] Trial Registered Prospectively
Last Modified On: 12/10/2019
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Nutraceutical 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Effect of protein intake on skeletal muscle health among healthy Indian adults 
Scientific Title of Study   Effect of protein supplementation on amino acid profile and skeletal muscle health among healthy Indian adults 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sucharita S 
Designation  Professor, Department of Physiology, St Johns Medical College 
Affiliation  St Johns Medical College 
Address  401, 3rd floor,Division of Nutrition, St Johns Medical College, Sarjapur road, Bangalore

Bangalore
KARNATAKA
560034
India 
Phone  080-49466322  
Fax    
Email  sucharita@stjohns.in  
 
Details of Contact Person
Scientific Query  
Name  Sucharita S 
Designation  Professor, Department of Physiology, St Johns Medical College 
Affiliation  St Johns Medical College 
Address  401, 3rd floor,Division of Nutrition, St Johns Medical College, Sarjapur road, Bangalore

Bangalore
KARNATAKA
560034
India 
Phone  080-49466322  
Fax    
Email  sucharita@stjohns.in  
 
Details of Contact Person
Public Query  
Name  Sucharita S 
Designation  Professor, Department of Physiology, St Johns Medical College 
Affiliation  St Johns Medical College 
Address  401, 3rd floor,Division of Nutrition, St Johns Medical College, Sarjapur road, Bangalore

Bangalore
KARNATAKA
560034
India 
Phone  080-49466322  
Fax    
Email  sucharita@stjohns.in  
 
Source of Monetary or Material Support  
Nutricia International Pvt Ltd The Centrium, Office No.1, Third Floor, LBS Marg, Kurla West, Mumbai – 400 070 
 
Primary Sponsor  
Name  Nutricia International Pvt Ltd 
Address  Phoenix Market City, Centrium Gate 1, Level 3, Office no: 1, L.B.S. Road, Kurla West, Mumbai - 400 070, India 
Type of Sponsor  Other [Nutraceutical company] 
 
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 Sucharita S  St Johns Medical College  401, 3rd floor, Division of Nutrition, Department of Physiology, St Johns Medical College, Sarjapur road, Bangalore-34
Bangalore
KARNATAKA 		 080-49466301

sucharita@stjohns.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
St Johns Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Healthy controls Age: 25-45 years BMI: 18.5- 24.9 kg/m2 Both males and females Muscle strength 1 SD from Indian data set 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Placebo group  8 week placebo arm supplementation + walking (150 min/week) 
Intervention  Protein intervention group  8 week intervention arm supplementation + walking (150 min/week) 
 
Inclusion Criteria  
Age From  25.00 Year(s)
Age To  45.00 Year(s)
Gender  Both 
Details  Healthy controls
BMI: 18.5- 24.9 kg/m2
Muscle strength < 1 SD from Indian data set 
 
ExclusionCriteria 
Details  1. H/O chronic diseases (Prediabetes, Type 2 DM, Hypertension, tuberculosis, cancer, chronic renal failure, ischemic heart disease, infections[tuberculosis, typhoid, dengue, etc. in the last 3 months etc)

2. H/O allergy to any form of protein intake (ex: soy)

3. Lactose intolerance

4. Alcohol intake greater than 2 STD per day

5. Any form of anaemia

6. Any form of peripheral neuropathy

7. Muscular dystrophies

8. Any form of joint injuries (knee and wrist)

9. Any form of surgeries on knee and wrist

10. History of osteoarthritis

11. Pregnancy

12. Consumption of protein supplements/nutritional supplement or Excess intake of protein than recommended

13. Those who exercise regularly (any form of resistance exercise/ heavy exercise, etc.) 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded 
Primary Outcome  
Outcome  TimePoints 
1. To study the acute effect of (12g) protein consumption on the changes in amino acid pool (through amino-acidomics) and skeletal muscle health (strength, endurance and fatigability) among healthy Indian adults.
2. To study the combined effect of 8 week protein supplementation and aerobic exercise (150 min brisk walking) on the changes in skeletal muscle health and amino acid pool among healthy Indian adults. 		 1.Acute study- Baseline, Day 7

2. Chronic study- Baseline, end of 8th week  
 
Secondary Outcome  
Outcome  TimePoints 
To study the combined effect of 8 week protein supplementation and aerobic exercise (150 min brisk walking) on the changes in skeletal muscle health and amino acid pool among healthy Indian adults.  Chronic study- Baseline, end of 8th week  
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
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)   24/12/2018 
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)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   None yet 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary   Protein ingestion (source, dose, timing, and pattern) is a key stimulus for preserving skeletal muscle mass and strength. Inadequate protein intake causes an imbalance in protein metabolism in skeletal muscle health. This in turn could lead into loss in muscle mass and strength. Understanding the role of adequate protein intake and its impact on  muscle health is important among Indian population, as majority of the population consume cereal based diet. With ageing changes in muscle health has been reported. The consequence of loss of muscle mass and strength with ageing will lead to reduced physical activity further causing chronic diseases. One of the ways it can be delayed is by providing adequate nutrition and exercise during middle age. So overall goal of the study is to increase our understanding of the role of protein supplementation and simple exercise like brisk walking among Indians on muscle health (muscle mass and strength). 
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