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

NCT07452757 | Completed

• 1 other identifier: AMW/ CTP/WMP/07-2022
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief 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)

Keywords

Weight management programme

Outcome Measures

Primary Outcomes (1)

• 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)

Secondary Outcomes (17)

• Change in BMI During Maintenance Phase

  Baseline (Day 1) to end of study (Day 90)

• Change in Body Fat Percentage

  Baseline (Day 1) to end of study (Day 90)

• Change in Waist Circumference

  Baseline (Day 1) to end of study (Day 90)

• Change in Total Cholesterol

  Baseline (Day 1) to end of study (Day 90)

• Change in Quality of Life

  Baseline (Day 1) to end of study (Day 90)

Study Arms (4)

Arm I (Control group)

NO INTERVENTION

Arm II (PRP-02 before all the meals)

EXPERIMENTAL

Dietary Supplement: Arm II

Arm III (1 meal replacement)

EXPERIMENTAL

Dietary Supplement: Arm III

Arm IV (2 Meal replacement)

EXPERIMENTAL

Dietary Supplement: Arm IV

Interventions

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)

Arm II (PRP-02 before all the meals)

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 III (1 meal replacement)

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)

Arm IV (2 Meal replacement)

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• \- Male and female subjects age between 20 to 45 years
• Non-pregnant and non-lactating
• Body Mass Index (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.

You may not qualify if:

• \- 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.

Sponsors & Collaborators

• Bioagile Therapeutics Pvt. Ltd.: lead

Study Sites (1)

Sapthagiri Institute of Medical Sciences & Research Centre

Bangalore, Karnataka, 560090, India

Location

MeSH Terms

Conditions

Overweight

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Divya Divya

  BioAgile Therapeutics Private Limited

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 30, 2026
• First Posted: March 5, 2026
• Study Start: November 15, 2023
• Primary Completion: May 13, 2024
• Study Completion: May 13, 2024
• Last Updated: March 12, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)