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This is an open-label, four-arm, randomized, controlled clinical study designed to evaluate the efficacy and safety of a structured Weight Management Program (WMP) in overweight and obese adults with a body mass index (BMI) ≥ 23 kg/m² (Asian Indian ethnicity cut-off). A total of 140 subjects will be enrolled and randomized equally into four arms: one control arm and three intervention arms with varying levels of nutritional intervention.
The Weight Management Program comprises three sequential phases: a pre-engagement gut-reset phase (10 days), an intensive intervention phase (30 days), and a maintenance phase (60 days). The intervention arms will receive combinations of meal replacements, protein supplements, fiber supplements, probiotics, and multivitamin-multimineral supplements, along with nutritional and behavioral counseling, calorie-deficit diet plans, and prescribed physical activity. The control arm will follow a free-living lifestyle without intervention.
The primary efficacy outcome is the proportion of subjects demonstrating a reduction in body weight and/or BMI from baseline to the end of the intensive phase. Secondary outcomes include changes in body weight and BMI at the end of the maintenance phase, maintenance of weight loss, changes in body composition, waist circumference, waist-hip ratio, lipid profile, metabolic parameters, physical activity, quality of life, and safety outcomes including adverse events.
The study aims to generate evidence on the effectiveness and safety of a holistic, lifestyle-based weight management program incorporating nutritional supplementation, dietary modification, physical activity, and behavioral support in overweight and obese individuals.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I (Control group) | No Intervention | ||
| Arm II (PRP-02 before all the meals) | Experimental |
| |
| Arm III (1 meal replacement) | Experimental |
| |
| Arm IV (2 Meal replacement) | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Arm II | Dietary Supplement | I. Investigational Product Morning- PRP-02 (1 scoop) + AND-16 Afternoon- PRP-02 (1 scoop) Night-PRP-02 (1 scoop) + FBR-18 (1 scoop) +PRO-19 II. Nutritional+ Behavioral counselling (Audio clips will be shared) III. Calorie deficit Diet Plan IV. Physical exercise: Moderate exercise - 30-60-minute exercise 5 days a week or 150-300-minute exercise per week (Exercise: brisk walking, aerobic exercise, jogging, cycling etc) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Body Weight | To assess the number and percentage of subjects demonstrating a reduction in body weight from baseline to the end of the intensive phase across intervention and control arms. | Baseline (Day 1) to end of intensive phase (Day 30) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in BMI During Maintenance Phase | To assess the number and percentage of subjects demonstrating a reduction in BMI from baseline to the end of the maintenance phase, and the proportion of subjects maintaining weight loss achieved during the intensive phase. | Baseline (Day 1) to end of study (Day 90) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Divya Divya | BioAgile Therapeutics Private Limited | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sapthagiri Institute of Medical Sciences & Research Centre | Bangalore | Karnataka | 560090 | India |
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| ID | Term |
|---|---|
| D050177 | Overweight |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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| Arm III | Dietary Supplement | I. Investigational Product - Replace breakfast with BDK-01+PRP-02 (2 scoops) Afternoon - as per diet plan Night- FBR- 18 (1 scoop) +PRO- 19 II. Nutritional + Behavioral counselling (Daily audio clips will be shared) III. Calorie deficit Diet Plan IV. Physical exercise: Moderate exercise - 30-60 minute exercise 5 days a week or 150 - 300 minute exercise per week (Exercise: brisk walking, aerobic exercise, jogging, cycling etc) |
|
| Arm IV | Dietary Supplement | I. Investigational Product Replace breakfast with BDK-01+PRP-02 (2 scoops) Afternoon-BDK-01+ Skimmed milk powder (Only during intensive phase, in maintenance phase switch to 1 meal replacement only) Night-FBR- 18+PRO- 19 II. Nutritional + Behavioral counselling (Daily audio clips will be shared) III. Calorie deficit Diet Plan IV. Physical exercise: Moderate exercise - 30-60 minute exercise 5 days a week or 150-300 minute exercise per week (Exercise: brisk walking, aerobic exercise, jogging, cycling etc) |
|
| Change in Body Fat Percentage |
To evaluate the change in body fat percentage from baseline to end of study using a validated body composition analyzer, and to compare the mean change between study arms. |
| Baseline (Day 1) to end of study (Day 90) |
| Change in Waist Circumference | To assess the change in waist circumference from baseline to the end of the study and to compare the mean change between intervention and control arms. | Baseline (Day 1) to end of study (Day 90) |
| Change in Total Cholesterol | To evaluate the change in total cholesterol levels from baseline to the end of the study and to compare the mean change between intervention and control arms. | Baseline (Day 1) to end of study (Day 90) |
| Change in Quality of Life | Change from baseline in quality of life assessed using the World Health Organization Quality of Life - Brief Version (WHOQOL-BREF) questionnaire from baseline to the end of the study. The WHOQOL-BREF is a validated 26-item questionnaire that assesses four domains: physical health, psychological health, social relationships, and environment. Domain scores are transformed to a 0-100 scale, where higher scores indicate better quality of life. | Baseline (Day 1) to end of study (Day 90) |
| Incidence of Adverse Events | To assess the incidence, severity, and relationship of adverse events reported during the study period across all study arms. | From baseline (Day 1) to end of study (Day 90) |
| Change in Muscle Mass | To evaluate the change in muscle mass from baseline to end of study using a validated body composition analyzer, and to compare the mean change between study arms. | Baseline (Day 1) to End of Study (Day 90) |
| Change in Fat-Free Mass | To evaluate the change in fat-free mass from baseline to end of study using a validated body composition analyzer, and to compare the mean change between study arms. | Baseline (Day 1) to End of Study (Day 90) |
| Change in Visceral Fat Level | To evaluate the change in visceral fat level from baseline to end of study using a validated body composition analyzer, and to compare the mean change between study arms. | Baseline (Day 1) to End of Study (Day 90) |
| Change in Waist-to-Hip Ratio | To assess the change in waist-to-hip ratio from baseline to the end of the study and to compare the mean change between intervention and control arms. | Baseline (Day 1) to End of Study (Day 90) |
| Change in Skinfold Thickness | To assess the change in skinfold thickness from baseline to the end of the study and to compare the mean change between intervention and control arms. | Baseline (Day 1) to End of Study (Day 90) |
| Change in Triglycerides | To evaluate the change in triglyceride levels from baseline to the end of the study and to compare the mean change between intervention and control arms. | Baseline (Day 1) to End of Study (Day 90) |
| Change in High-Density Lipoprotein (HDL) Cholesterol | To evaluate the change in HDL cholesterol levels from baseline to the end of the study and to compare the mean change between intervention and control arms. | Baseline (Day 1) to End of Study (Day 90) |
| Change in Low-Density Lipoprotein (LDL) Cholesterol | To evaluate the change in LDL cholesterol levels from baseline to the end of the study and to compare the mean change between intervention and control arms. | Baseline (Day 1) to End of Study (Day 90) |
| Change in Fasting Blood Glucose | To evaluate the change in fasting blood glucose levels from baseline to the end of the study and to compare the mean change between intervention and control arms. | Baseline (Day 1) to End of Study (Day 90) |
| Change in Glycated Hemoglobin (HbA1c) | To evaluate the change in HbA1c levels from baseline to the end of the study and to compare the mean change between intervention and control arms. | Baseline (Day 1) to End of Study (Day 90) |
| Change in Serum Insulin | To evaluate the change in fasting serum insulin levels from baseline to the end of the study and to compare the mean change between intervention and control arms. | Baseline (Day 1) to End of Study (Day 90) |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |