| CTRI Number |
CTRI/2023/11/060037 [Registered on: 20/11/2023] Trial Registered Prospectively |
| Last Modified On: |
17/11/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A Comparative Analysis Of The Effect Of Different Protein Intake and Resistance Training On Muscle Mass, Muscle Strength, And Fat Mass in Postmenopausal Women With Diabetes And Obesity. |
|
Scientific Title of Study
|
Pilot Real World Study on the Effects Of Different Protein Intake and Resistance Training on Muscle Mass, Muscle Strength, and Fat Mass in Postmenopausal Women with Diabetes and Obesity: A Comparative Analysis of Normal diet, 15g and 30g Protein Intake |
| 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 SANJAY AGARWAL |
| Designation |
CONSULTANT PHYSICIAN |
| Affiliation |
RUBY HALL CLINIC |
| Address |
Ruby Hall Clinic, 40, Sasoon Road, Sangamwadi, Pune, Maharashtra, 411001
Department of Internal Medicine, Division of Diabetes and Metabolic Disorders, Room number- OPD 1
Pune
MAHARASHTRA
411001
India |
| Phone |
9822091220 |
| Fax |
|
| Email |
agarwalclinic@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR SANJAY AGARWAL |
| Designation |
CONSULTANT PHYSICIAN |
| Affiliation |
RUBY HALL CLINIC |
| Address |
Ruby Hall Clinic, 40, Sasoon Road, Sangamwadi, Pune, Maharshtra, 411001
Department of Internal Medicine, Division of Diabetes and Metabolic Disorders, Room number- OPD 1
Pune
MAHARASHTRA
411001
India |
| Phone |
9822091220 |
| Fax |
|
| Email |
agarwalclinic@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR SANJAY AGARWAL |
| Designation |
CONSULTANT PHYSICIAN |
| Affiliation |
RUBY HALL CLINIC |
| Address |
Ruby Hall Clinic, 40, Sasoon Road, Sangamwadi, Pune, Maharashtra, 411001
Department of Internal Medicine, Division of Diabetes and Metabolic Disorders, Room number- OPD 1
Pune
MAHARASHTRA
411001
India |
| Phone |
9822091220 |
| Fax |
|
| Email |
agarwalclinic@gmail.com |
|
|
Source of Monetary or Material Support
|
| Ruby Hall Clinic, 40, Sasoon Road, Sangamwadi, Pune, Maharashtra, 411001 |
|
|
Primary Sponsor
|
| Name |
RUBY HALL CLINIC |
| Address |
Department of Internal Medicine, Division of Diabetes and Metabolic Disorders, Room Number- OPD 1, 40,Sasoon Road, Sangamwadi, Pune, Maharashtra,411001
|
| Type of Sponsor |
Private hospital/clinic |
|
|
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 SANJAY AGARWAL |
RUBY HALL CLINIC |
Department of Internal Medicine, Division of Diabetes and Metabolic Disorders, Room number- OPD 1, 40, Sasoon Road, Sangamwadi, Pune, Maharashtra, 411001
Pune
MAHARASHTRA |
9822091220
agarwalclinic@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| POONA MEDICAL RESEARCH FOUNDATION |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E116||Type 2 diabetes mellitus with other specified complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Comparative Analysis of Normal diet, 15g, and 30g Protein Intake- Effects of Different Protein Intake and Resistance Training on Muscle Mass, Muscle Strength, and Fat Mass in Postmenopausal Women with Diabetes and Obesity |
Addition of Supplemental Protein of 15 grams and 30 grams to the normal diet. |
| Intervention |
Comparative Analysis of Normal diet, 15g, and 30g Protein Intake- Effects of Different Protein Intake and Resistance Training on Muscle Mass, Muscle Strength, and Fat Mass in Postmenopausal Women with Diabetes and Obesity |
Standard diet consisting of the daily diet taken by the patients |
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Female |
| Details |
Post-menopausal women ages between 45 to 60 years are included with a history of Diabetes
BMI greater than or equal to 30 kg/ m²
HbA1C greater than or equal to 6.5%
|
|
| ExclusionCriteria |
| Details |
WOMEN WHO ARE NOT WITHIN THE AGE GROUP OF 45 TO 60 YEARS
WOMEN WHO ARE NOT DIABETIC
eGFR LESSER THAN 60MM/HR
ANY MALIGNANCIES
TYPE 1 DIABETIES MELLITUS
WOMEN WHO HAVE PAIN SCORES |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Assessing the Muscle Mass with regards to the changes made with the Protein Intake and the Resistance Training |
The time period will be 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Assessing the Muscle Mass with regards to the changes made with the Protein intake & Resistance Training. We will be saving the blood transfusions for the detection of HbA1C values & will use it for the later phases of the trial. |
Time period will be one year from now |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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
|
Phase 1/ Phase 2 |
|
Date of First Enrollment (India)
|
27/11/2023 |
| 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="3"
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
|
The study will be conducted with 90 postmenopausal women aged between 45 to 60 years old where in they will be divided into 3 groups for the trial.
Each group will be sub-divided into 2 groups based on whether they received resistant training or not with a supplemental addition of protein in 15g and 30g.
This will be to study the additional benefit of resistance training over protein supplementation.
We will be hosting virtual training programs, and for the benefit of those unable to attend physically, consultation will be done online, and we will be archiving the video recordings for later access.
|