| 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 |
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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 |
|
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Source of Monetary or Material Support
|
| Amway Global Services India Pvt Ltd, Gurugram, Haryana, India |
|
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Primary Sponsor
|
| Name |
Amway Global Services India Pvt Ltd, |
| Address |
Gurugram, Haryana, India |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
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Details of Secondary Sponsor
|
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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 |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E663||Overweight, |
|
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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) |
|
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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. |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
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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 |
|
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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
|
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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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