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CTRI Number  CTRI/2023/07/054680 [Registered on: 03/07/2023] Trial Registered Prospectively
Last Modified On: 26/11/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Nutraceutical 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   To evaluate efficacy and safety of proprietary healthy diet combinations for weight management in overweight volunteers 
Scientific Title of Study   To evaluate the efficacy and safety of Weight Management Program in Overweight/Obese Individuals: A 4 Arm open label randomized controlled clinical study 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
AMW/ CTP/WMP/07-2022 Version: 1.0 Date:25.05.2023  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Reginald Varadarajulu 
Designation  MBBS, MD, DNB (Neurology) 
Affiliation  Medstar Speciality Hospital 
Address  641/17,First Floor, Department of Internal Medicine, Neurology Division, Medstar Speciality Hospital, 1/3, Kodigehalli Main Rd, Sahakar Nagar, Sanjeevini Nagar, Bengaluru-560092, Karnataka

Bangalore
KARNATAKA
560092
India 
Phone  8041127524  
Fax    
Email  medstarclinicalresearch@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Divya Chandradhara 
Designation  CEO 
Affiliation  BioAgile Therapeutics Pvt Ltd 
Address  #2/5, Dahlia Building, 3rd Floor, 80 Feet Road, RMV 2nd Stage,, Bengaluru, Karnataka

Bangalore
KARNATAKA
560094
India 
Phone  9538961761  
Fax    
Email  divya@bioagiletherapeutics.com  
 
Details of Contact Person
Public Query
 
Name  Divya Chandradhara 
Designation  CEO 
Affiliation  BioAgile Therapeutics Pvt Ltd 
Address  #2/5, Dahlia Building, 3rd Floor, 80 Feet Road, RMV 2nd Stage,, Bengaluru, Karnataka

Bangalore
KARNATAKA
560094
India 
Phone  9538961761  
Fax    
Email  divya@bioagiletherapeutics.com  
 
Source of Monetary or Material Support  
Amway Global Services India Pvt Ltd, Gurugram, Haryana, India 
 
Primary Sponsor  
Name  Amway Global Services India Pvt Ltd, 
Address  Gurugram, Haryana, India 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Reginald Varadarajulu   Medstar Speciality Hospital  641/17, First Floor, Department of Internal Medicine, Neurology Division, Medstar Speciality Hospital, 1/3, Kodigehalli Main Rd, Sahakar Nagar, Sanjeevini Nagar, Bengaluru, Karnataka 560092
Bangalore
KARNATAKA 
8041127524

medstarclinicalresearch@gmail.com 
Dr Nagaraj N MBBS PGDGM Geriatric Medicine MD General Medicine  Sapthagiri Institute of Medical Sciences and Research Center  Professor and HOD, Department of General Medicine, Room No.07, 1st floor, General Medicine Department OPD Sapthagiri Institute of Medical Sciences and Research Center, 15, Hesarghatta Rd, Navy Layout, Chikkasandra, Chikkabanavara, Bengaluru, Karnataka 560090
Bangalore
KARNATAKA 
7702990688

drnagaraj@rediffmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Institutional Ethics committee Sapthagiri Institute of Medical Sciences & Research Centre   Approved 
Medstar Speciality Hospital EC  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E663||Overweight,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  1 meal replacement  Replace breakfast with BDK-01+PRP-02 (2 scoops) Afternoon – as per diet plan Night- FBR- 18+PRO- 19; FBR - 18 twice daily (1 scoop 30 minutes before breakfast and dinner fixed in 250 ml of water) and 1 capsule of PRO – 19 post dinner. Intensive Phase (30 days) and Maintenance Phase (60 days)  
Intervention  2 meal replacements  Replace breakfast with BDK-01+PRP-02 (2 scoops) – (for 3 months) Afternoon-BDK-01+Skimmed milk (300 ml) (for 1 month only, post which meal as per diet plan can be taken in the afternoon) Night-FBR- 18+PRO- 19; FBR - 18 twice daily (1 scoop 30 minutes before breakfast and dinner fixed in 250 ml of water) and 1 capsule of PRO – 19 post dinner. Intensive Phase (30 days) and Maintenance Phase (60 days)  
Comparator Agent  NIL  Free living humans. No intervention. 
Intervention  PRP-02- 10 minutes before all 3 meals- ideal to mix with buttermilk/ skimmed milk / water.  Morning- PRP-02 (1 scoop) + AND-16 Afternoon- PRP-02 (1 scoop) Night-PRP-02 (1 scoop) + FBR-18 + PRO-19; FBR - 18 twice daily (1 scoop 30 minutes before breakfast and dinner fixed in 250 ml of water) and 1 capsule of PRO – 19 post dinner. Intensive Phase (30 days) and Maintenance Phase (60 days)  
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  45.00 Year(s)
Gender  Both 
Details  Male and female subjects age between 20 to 45 years
Non-pregnant and non-lactating
BMI (kg/m2)- ≥ 23 (considered overweight/obese as per the ethnicity cut off values for Asian
Indians)
Following stable eating habits
Not on any medication that can affect Lipid profile, body composition or weight
Nonalcoholic and non- smoker
Subjects who are willing to sign the informed consent and comply with study requirement of meal replacements strictly.
Women in the reproductive age group- should be agreeing to follow standard contraceptive measures
Individuals who are seriously motivated to lose weight and willing to be part of any one of the interventions where Protein drink with buttermilk, skimmed milk or water OR 1 Meal replacement OR 2 Meal replacement would be given.



 
 
ExclusionCriteria 
Details  -On medication/ HRT (Hormone Replacement Therapy)
-Suffering from endocrine hypothalamic- pituitary disease, women with PCOS, adrenal disorder, hypothyroidism,
-Subjects with Diabetes type 1 or 2 to be excluded
-Women in the reproductive age group not willing to use standard contraceptive measures.
-Other conditions like CKD, stones, liver dysfunction (with elevated enzyme levels), history of cancer, eating disorders, chronic gastrointestinal disorders (IBD or celiac), metabolic disorders like hypertension, CVDs- that might impair the outcomes
-Malignancy which is currently active or in remission for less than five years after last treatment
-Unstable weight (± 5 % fluctuation in their body weight for past 8-weeks at study entry)
-Have undergone gastroplasty or weight reducing surgery
-Subjects who have participated in another clinical study within the past 30 days prior to screening or are likely to simultaneously participate in another clinical study.
-Practicing any structured commercial weight management program/ intermittent fasting or any diet regime in the last 30 days prior to screening.
-Patients who are doubtful to comply with study procedures for mental, psychological or social reasons. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To evaluate the number & percentage of subjects demonstrating reduction in BMI/ weight between inter & intra arms from baseline to the end of the intensive phase.

To evaluate number & percentage of subjects demonstrating reduction in BMI/ weight between inter & intra arms from baseline to the end of the maintenance phase.

Gut reset (-10 to Day 0) phase (except control arm): Will precede intensive and maintenance phase.  
Intensive phase (Day 1 to Day 30)
During the intensive phase, all the intervention arms will be followed up on daily basis with
-Daily Telephonic calls
-Weekly once on-site visit

Maintenance Phase (Day 31 to Day 60)
During the maintenance phase, all the intervention arms will be followed up on weekly basis with
-Weekly Telephonic call &
-Biweekly once on-site visit

 
 
Secondary Outcome  
Outcome  TimePoints 
To assess the number of subjects between inter and intra arms maintaining the lost weight after intensive phase.  Day 31 to Day 60 
To evaluate the reduction in skinfold thickness and WHR among subjects between inter and intra arms   Day 1 and Day 90 
To evaluate the changes in Body fat percentage among subjects between inter and intra arms   Day 1 and Day 90 
To assess the number and percentage of subjects demonstrating improvement in lipid profile between inter and intra arms  Day 1 and Day 90 
To assess the number and percentage of subjects demonstrating improvement in parameters assessed by Body composition analyzer  Day 1, Day 7, Day 15, Day 22, Day 30, Day 45, Day 60, Day 75 and Day90 
Changes in the quality of life using WHOQOL- BREF between inter and intra arms  Day 1 and Day 90 
Changes in the clinical parameters between inter and intra arms  Day 1 and Day 90 
Incidence of any adverse events during study in each arm  Day 1 and Day 90 
Compliance to the study  Day 7, 15, 22, 30, 37, 45,52, 60, 67, 75 and Day 82 
 
Target Sample Size   Total Sample Size="140"
Sample Size from India="140" 
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)   17/07/2023 
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="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
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  
Overweight and obesity are defined as abnormal or excessive fat accumulation that may impair health. This illness is a global pandemic with a high prevalence in western societies but also fast spreading across developing countries. According to one study, it is predicted that the prevalence of overweight will be more than double among Indian adults aged 20–69 years between 2010 and 2040, while the prevalence of obesity will triple. It is a major risk factor for several lifestyle conditions such as metabolic syndrome, Diabetes, hypertension, CVDs, atherosclerosis and sleep disorders. A wide variety of obesity management strategies are presently practiced including lifestyle changes in terms of diet and physical activity; behavioral treatment strategies to improve adherence to lifestyle interventions; pharmacological and herbal dietary products-based strategies and bariatric surgery for treating extreme cases. The science and philosophy behind a healthy weight management program is to provide a multifaceted support focusing on lifestyle modification with inclusion of the essential components of nutrition, physical activity and even product interventions as weight control measures. Many studies have demonstrated the use of meal replacements as an effective and proven solution in structured weight loss. Similarly, amount and timing of consumption of nutrients like protein and fiber has also been an established evidence in successful weight loss strategies. To add on to the benefit, the gut reset component has been a crucial aspect as well. Trillions of bacteria residing in intestine are known as gut microbiome. These microbes digest the complex carbohydrates and release short chain fatty acids which are known to play crucial role in various metabolic functions including glucose metabolism. Imbalanced diet, sedentary lifestyle, lack of sleep, antibiotics can cause an imbalance in the gut microbial ecosystem. This, in turn, is closely associated with weight gain.

 
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