| CTRI Number |
CTRI/2024/04/065016 [Registered on: 01/04/2024] Trial Registered Prospectively |
| Last Modified On: |
26/03/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A clinical study to evaluate the effect of a test product (Meal Replacement Supplement) on weight management in overweight / obese patients. |
|
Scientific Title of Study
|
An open label, single arm, prospective, multicentric, interventional clinical study to evaluate the effect of Meal Replacement Supplement on weight management in overweight / obese patients. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| C3B03851; DRL-IND-GGI-057-CELE/2024; Ver:01, Dated 04 Mar 24 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Parth Joshi |
| Designation |
Overall Trial Coordinator |
| Affiliation |
Cliantha Reseach |
| Address |
Consumer Research Department,
Corporate House 17, Sigma 1 Corporate House,
BH. Rajpath Club, Off Sindhubhavan Road,
Nr. Mann Party Plot Cross Road,
Bodakdev, Ahmedabad.
Phone No.: 91-79-66135601
Ahmadabad
GUJARAT
380054
India |
| Phone |
8000085049 |
| Fax |
|
| Email |
pjoshi@cliantha.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sukhada Bhatte |
| Designation |
Nutrition Science Specialist |
| Affiliation |
Dr Reddys Laboratories Ltd |
| Address |
No 7-1, 27, Ameerpet Road, Leelanagar,
Ameerpet, Hyderabad, Telangana
Hyderabad
TELANGANA
500016
India |
| Phone |
9820023305 |
| Fax |
|
| Email |
sukhadab@drreddys.com |
|
Details of Contact Person
Public Query
|
| Name |
Sukhada Bhatte |
| Designation |
Nutrition Science Specialist |
| Affiliation |
Dr Reddys Laboratories Ltd |
| Address |
No 7-1, 27, Ameerpet Road, Leelanagar,
Ameerpet, Hyderabad, Telangana
Amreli
TELANGANA
500016
India |
| Phone |
9820023305 |
| Fax |
|
| Email |
sukhadab@drreddys.com |
|
|
Source of Monetary or Material Support
|
| Cliantha Research, Corporate House 17, Sigma 1 Corporate House, BH. Rajpath Club, Off Sindhubhavan Road, Nr. Mann Party Plot Cross Road, Bodakdev, Ahmedabad-380054, Gujarat, India. |
| Dr Reddy’s Laboratories Ltd., 7-1-27, Ameerpet, Hyderabad, Telangana – 500016, India. |
|
|
Primary Sponsor
|
| Name |
Dr. Reddys Laboratories Ltd. |
| Address |
7-1-27, Ameerpet,
Hyderabad, Telangana - 500016 |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Not Applicable |
Not Applicable |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Vipul Doshi |
Cliantha Research (Site 2) |
Corporate House 17,
Sigma 1 Corporate House,
BH. Rajpath Club,
Off Sindhubhavan Road,
Nr. Mann Party Plot Cross Road,
Bodakdev, Ahmedabad-380054, Gujarat.
Ahmadabad
GUJARAT |
91-79-66135601
vipul4500@yahoo.co.in |
| Dr Banshi Saboo |
Diabetes Care & Hormone Clinic (Site 1) |
1-2, Gandhi Park,
Nr. Nehrunagar Cross Road,
Ambawadi, 380015, Gujarat, India.
Ahmadabad
GUJARAT |
09824047676
banshisaboo@hotmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| OM |
Approved |
| OM |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E669||Obesity, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Meal Replacement Supplement |
One serving (providing 50 gm of test product mixed in 250 ml of water) will be consumed per day instead on one meal i.e., Lunch/Dinner for duration of 90 days. |
| Comparator Agent |
Not Applicable |
Not Applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1) Subjects with BMI from 23 kg/m2 to 32 kg/m2.
2) Subjects with a history of stable weight, defined as no significant weight change (± 5%) within three months prior to enrollment.
3) Subjects not participating in similar program or not using any natural/ herbal supplement or any other drug/nutraceutical for weight loss.
4) Subjects able to adjust diet or take nutrition and supplements daily with the guidance of a nutritionist.
5) Female subjects of childbearing potential must have a negative urine pregnancy test performed at screening visit.
6) Subjects who are willing to participate in the study and give voluntary written informed consent.
7) Subjects who are willing and able to follow the study protocol to participate in the study. |
|
| ExclusionCriteria |
| Details |
1) Subjects consuming probiotics / prebiotics 30 days prior to study.
2) Subjects using supplements that are rich in dietary fibre or protein which influences satiety assessment.
3) Subjects taking appetite stimulants or on steroid treatment or on hormone therapy.
4) Subjects who have a history of Insulin dependent diabetes / with Type I diabetes / with uncontrolled Type 2 diabetes.
5) Subjects who have hypothyroidism or hyperthyroidism as confirmed by lab test (T3, T4, TSH).
6) Subjects having limitation in doing physical activity/exercise for at least 20 to 30 mins daily.
7) Subjects who have undergone hospitalization for an infectious condition within 4 weeks prior to study entry.
8) Subjects participating in other similar therapeutic trials within the last four weeks. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1) Assessment of body weight, waist and hip circumference, waist–hip ratio (WHR) and body mass index (BMI).
2) Assessment of Basal Metabolic Rate, Skeletal Muscle Mass, Body Fat Mass and % Body Fat using Body Composition Analyzer. |
Day 00 (before product administration), Day 31, Day 61 and Day 91 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Assessment of glycated hemoglobin levels (HbA1c). |
Day 00 (before product administration), Day 91 |
| Assessment of Fasting Blood Glucose and Post Prandial Blood Glucose |
Day 00 (before product administration), Day 61, Day 91 |
| Assessment of Total cholesterol, Triglycerides, LDL and HDL levels. |
Day 00 (before product administration), Day 61, Day 91 |
| Assessment of daily dietary intake (in terms of Total caloric intake, Carbohydrate intake, Protein intake, Fat intake and Fibre intake) using 24-hour dietary recall. |
Day 00 (before product administration), Day 31, Day 61, Day 91 |
| Assessment of likeliness of feeling hunger and increase in subjective satiety using Visual analog scale (VAS) |
Day 00 (before product administration), Day 31, Day 61, Day 91 |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
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)
|
08/04/2024 |
| 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="1" |
|
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
|
This is an open label, single arm, multicentric clinical study to evaluate the effect of a meal replacement supplement in weight management in overweight / obese patients.
The potential subjects will be screened as per the inclusion and exclusion criteria only after obtaining written informed consent from the subjects.
All eligible subjects will undergo blood tests and clinical assessment. Subjective feedback will also be taken regarding the changes in daily dietary intake. Safety will be assessed throughout the study by monitoring adverse events. |