| CTRI Number |
CTRI/2025/04/083843 [Registered on: 02/04/2025] Trial Registered Prospectively |
| Last Modified On: |
31/03/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Scientific Evaluation of the Consumption of Cow’s Milk on Human Health and Disease |
|
Scientific Title of Study
|
Scientific Evaluation of the Consumption of Cow’s Milk on Human Health and Disease |
| 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 Prajakta H Paradkar |
| Designation |
Principal Investigator |
| Affiliation |
Kasturba Health Society Medical Research Centre |
| Address |
Kasturba Health Society Medical Research Centre, Division of Cell and Molecular Biology, 6th Floor, 17, KD Raod, vile parle west, Mumbai
Mumbai
MAHARASHTRA
400056
India |
| Phone |
9702029317 |
| Fax |
|
| Email |
prajakta.hsp@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Prajakta H Paradkar |
| Designation |
Principal Investigator |
| Affiliation |
Kasturba Health Society Medical Research Centre |
| Address |
Kasturba Health Society Medical Research Centre, Division of Cell and Molecular Biology, 6th Floor, 17, KD Raod, vile parle west, Mumbai
Mumbai
MAHARASHTRA
400056
India |
| Phone |
9702029317 |
| Fax |
|
| Email |
prajakta.hsp@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Hemant Paradkar |
| Designation |
Associate Professor |
| Affiliation |
Ayurved Mahavidyala Sion |
| Address |
Near Sion station, Sion, Mumbai
Mumbai
MAHARASHTRA
400022
India |
| Phone |
9987519315 |
| Fax |
|
| Email |
hemant.paradkar@gmail.com |
|
|
Source of Monetary or Material Support
|
| Bombay Gow Rakshak Trust, 121, Jolly Makers Chamber II, Nariman point, Mumbai-400021, Maharashtra, India |
|
|
Primary Sponsor
|
| Name |
Bombay Gow Rakshak Trust |
| Address |
Bombay Gow Rakshak Trust, 121, Jolly Makers Chamber II, Nariman point, Mumbai-400021, Maharashtra, India |
| Type of Sponsor |
Other [Trust] |
|
|
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 Hemant Paradkar |
Kayachikitsa department, Ayurved Mahavidyalaya Sion |
APMs Ayurved Mahavidyalaya and Seth RV Ayurvedic Hospital, Near Sion station, Sion east, Mumbai-400022
Mumbai
MAHARASHTRA |
9987519315
hemant.paradkar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Ayurved Mahavidyalaya, Sion |
Approved |
| Intersystem Biomedica Ethics commiittee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
None |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Gir cow milk |
300ml milk in 2 doses for 3 months |
| Comparator Agent |
NA |
NA |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
29.00 Year(s) |
| Gender |
Both |
| Details |
All persons who are willing to participate will undergo a physical health checkup |
|
| ExclusionCriteria |
| Details |
Persons who are diabetic/ having metabolic syndrome, hypertension, any prolonged illness including infection/communicable disease, any gastro-intestinal problems including milk allergy/lactose intolerance |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in Metabolic and inflammatory markers |
12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement in anthropometry and body composition |
3 months |
|
|
Target Sample Size
|
Total Sample Size="25"
Sample Size from India="25"
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)
|
15/04/2025 |
| 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 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
|
Objective To evaluate
the effect of milk consumption on selected metabolic and
inflammatory markers in young adults. The
study will be conducted in three phases. Phase I Baseline study of participants
Demographic information, personal and family medical history, will be recorded.
Body composition measurements will be taken to measure percent body fat,
visceral and abdominal fat, as well as muscle mass. Fasting blood samples will
be taken for measurement of complete blood count, blood glucose and insulin,
lipid profile i.e. total cholesterol, triglycerides, LDL cholesterol, HDL
cholesterol, glycosylated hemoglobin, as well as selected inflammatory markers
namely IL-6, TNF-alpha, chemerin, hs-CRP. In Phase II Subjects will be provided
with cow milk. Each subject will be instructed to boil the cow milk and consume
300 ml of milk in two doses of 150 ml each. All participants in this study will
be insured. Phase III At endline of the
three month intervention period, all measurements that were done at baseline
will be repeated. |