To Evaluate Efficacy and Safety of Proprietary Healthy Diet Combinations for Weight Management in Overweight Volunteers

Summary

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.

Conditions

• Overweight (BMI > 25)

Interventions

DIETARY_SUPPLEMENT

Arm II

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)

DIETARY_SUPPLEMENT

Arm III

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)

DIETARY_SUPPLEMENT

Arm IV

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)

Sponsors & Collaborators

• Bioagile Therapeutics Pvt. Ltd.

  lead INDUSTRY

Principal Investigators

• Divya Divya · BioAgile Therapeutics Private Limited

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

20 Years

Max Age

45 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2023-11-15

Primary Completion

2024-05-13

Completion

2024-05-13

Countries

• India

Study Locations