A clinical trial to evaluate the efficacy and safety of meal replacement regime for studying the outcome of weight maintenance in obese participants.
Scientific Title of Study
A randomized, parallel, two-arm clinical trial to evaluate the efficacy and safety of a Meal Replacement regime for weight reduction and maintenance in Obese adults.
Trial Acronym
NIL
Secondary IDs if Any
Secondary ID
Identifier
PRPL-AETL-2811-2025 Version 1 Dated 22-Dec-2025
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Dr Dayanand Balappa Yaligar
Designation
MBBS, MD
Affiliation
Sri Laxmi Hospital
Address
Basement OPD No 02
Sri Laxmi Hospital, 50, Opposite Velankani Road, Doddathoguru, Electronic City, Bengaluru, Karnataka
Bangalore KARNATAKA 560100 India
Phone
9980576966
Fax
Email
dayanandyaligar@gmail.com
Details of Contact Person Scientific Query
Name
Dr Abhijit Rathi
Designation
Principal Scientist II
Affiliation
Advanced Enzymes Technologies Ltd
Address
5th Floor, A wing, Sun Magnetica LIC Service Road, Louiswadi, Thane West, India
Thane MAHARASHTRA 400604 India
Phone
9970092220
Fax
Email
akrathi@advancedenzymes.com
Details of Contact Person Public Query
Name
Dr Mukul Maurya
Designation
Director
Affiliation
Proclin Research Pvt Ltd
Address
2nd floor, Plot no 1, Nevri Hills, Gufa Mandir road, Lalghati, Bhopal, India
Bhopal MADHYA PRADESH 462030 India
Phone
7032802286
Fax
Email
mukul@proclinresearch.com
Source of Monetary or Material Support
Advanced Enzymes Technologies Ltd, 5th Floor, A wing, Sun Magnetica LIC Service Road, Louiswadi Thane West 400604, India
Primary Sponsor
Name
Advanced Enzymes Technologies Ltd
Address
5th Floor, A wing, Sun Magnetica LIC Service Road, Louiswadi Thane West 400604, India
Type of Sponsor
Pharmaceutical industry-Indian
Details of Secondary Sponsor
Name
Address
NIL
NIL
Countries of Recruitment
India
Sites of Study
No of Sites = 2
Name of Principal
Investigator
Name of Site
Site Address
Phone/Fax/Email
Dr Udayakumar N
Abiramm Hospital
Ground floor OPD No 01,
Abiramm Hospital, Hosur Main Road, State Bank of Patiala Building, Hosa Road, Above Vinodha Diagnostics, Bengaluru, Karnataka 560100 Bangalore KARNATAKA
9742052111
tvnudayakumar1@gmail.com
Dr Dayanand Balappa Yaligar
Sri Laxmi Hospital
Basement OPD No 02
Sri Laxmi Hospital, 50, Opposite Velankani Road, Doddathoguru, Electronic City, Bengaluru, Karnataka 560100 Bangalore KARNATAKA
9980576966
dayanandyaligar@gmail.com
Details of Ethics Committee
No of Ethics Committees= 2
Name of Committee
Approval Status
ACE Independent Ethics Committee
Approved
ACE Independent Ethics Committee
Approved
Regulatory Clearance Status from DCGI
Status
Not Applicable
Health Condition / Problems Studied
Health Type
Condition
Patients
(1) ICD-10 Condition: E669||Obesity, unspecified,
Intervention / Comparator Agent
Type
Name
Details
Intervention
Meal replacement formula
Study 1A -
50 gm, one sachet daily for dinner, oral route of administration, consume with water as meal, consume for 90 days
Comparator Agent
Placebo
Study 1B -
350 mg, 2 capsules before lunch and 2 capsules before dinner, oral route of administration, swallow as a whole with water, consume for 90 days
Intervention
SlimSEB
Study 1A -
350 mg, 2 capsules before lunch, oral route of administration, swallow as a whole with water, consume for 90 days
Study 1B -
350 mg, 2 capsules before lunch and 2 capsules before dinner, oral route of administration, swallow as a whole with water, consume for 90 days
Inclusion Criteria
Age From
18.00 Year(s)
Age To
65.00 Year(s)
Gender
Both
Details
Study 1A
1. Self reported healthy adults between 18 to 65 years
2. Individuals with a BMI ranging from 35 to 45 kg/m2, inclusive
3. Weight stable ±3 kg weight loss or gain in the past 2 months
4. Able to give free, informed and express consent to participate
5. Individuals seeking to consult a nutritionist for personalized weight-loss diet plan
6. Participants should be in overall good physical and mental health, not regularly using any medications or dietary supplements, and must be willing to discontinue probiotic supplements probiotic enriched products and fibre supplements if applicable for at least the last 2 months
prior to enrolment. They should also commit to maintaining a consistent dietary pattern throughout the study period.
7. Individuals judged appropriate for the study by the attending physician.
8. Willingness to complete all study visits, assessment questionnaires, and diaries.
Study 1B
1. Eligible individuals from study 1A who have lost greater than or equal to 5% of their body weight in last 3 months due to IP
2. Willing to sign ICF
ExclusionCriteria
Details
Study 1A
1. Diagnosed with a general physical or mental health problem e.g. peptic ulcer, inflammatory
bowel disease, depression, anxiety, insomnia, acute metabolic complications, endocrine diseases, hypoglycaemia, etc. or systemic disease that may pose a safety risk, interfere with the dietary intake of the investigational product, or impact the assessment of study outcomes.
2. Cardiovascular diseases or medical conditions unsuitable for exercise, hypertension, metabolic
disorders or concurrent dietary supplement use.
3. Taking weight or appetite affecting medications or drugs like selective serotonin reuptake inhibitors SSRIs, GLP-1 receptor agonists and steroids and gastrointestinal motility-affecting
medications.
4. Liver function damage, Urinary or reproductive system infection, renal dysfunction.
5. Chronic diseases like cancer, chronic obstructive pulmonary disease, asthma, chronic gut diseases, nephropathy, psychoses, dementia, hypothyroid
6. Individuals likely to develop an allergy to the test substance like milk products and lactose intolerant.
7. Participants must not be currently enrolled in another clinical trial or planning to enroll in one during the study period and must comply with the required exclusion period following participation in any prior study.
8. Diagnosed with an autoimmune disease or are immune compromised due to medical condition or medications intake e.g. acquired immunodeficiency HIV, organ transplant, lymphoma, chemotherapy, chronic corticosteroids intake, etc.
9. Chronic alcohol/drugs/tobacco dependency/addicted.
10. Pregnant women, women desiring to become pregnant, or lactating women.
11. History of any surgery in the past 3 months.
12. Individuals judged inappropriate for the study by the attending physician
Study 1B
1. Participants with side effect to the IP
Method of Generating Random Sequence
Other
Method of Concealment
Not Applicable
Blinding/Masking
Not Applicable
Primary Outcome
Outcome
TimePoints
Study 1A
Anthropometric parameters
1. Evaluation of change in body weight
2. Evaluation of change in BMI
3. Evaluation of change in body measurements
Study 1B
Anthropometric parameters
1. Evaluation of change in body weight
2. Evaluation of change in BMI
3. Evaluation of change in body measurements
Study 1A
Day 1, 2, 47, 92
Study 1B
Day 92, 93, 138, 183
Secondary Outcome
Outcome
TimePoints
Study 1A
1. Changes in glucose and insulin related parameters
i. Fasting plasma glucose FPG mmol/L
ii. Fasting insulin micro IU/mL
iii. Hemoglobin A1c HbA1c %
iv. Homeostatic Model Assessment for Insulin Resistance HOMAIR
v. Homeostasis model assessment of beta-cell function HOMA beta
vi. Disposition index DI
vii. Quantitative insulin sensitivity checks index QUICKI
2. Change in lipid profile
i. Total cholesterol mg/dL
ii. LDL-C mg/dL
iii. HDL-C mg/dL
iv. VLDL-C mg/dL
v. Triglycerides mg/dL
3. Change in vital physical indicators
i. Body temperature
ii. Systolic blood pressure
iii. Diastolic blood pressure
iv. Pulse rate
v. Respiration rate
Study 1A
Day 1, 2, 47, 92
Study 1A
4. Change in hematological parameters
i. Hematological-Complete and differential blood count, platelets.
ii. Biochemical-Serum Glutamic-Oxaloacetic Transaminase, Serum Glutamic Pyruvic Transaminase, serum creatinine, blood urea nitrogen, random blood sugar, total cholesterol, total albumin and globulin and C-Reactive Protein, Thyroid TSH, T3, T4
5. Body Mass Composition Assessment
6. Assessment of tolerability
i. The investigator will evaluate tolerability by asking the subject for any side effects or discomfort.
7. Assessment of Quality of life
i. The quality of life will be assessed during each visit.
8. Adverse events and serious adverse events:
i. Any adverse or Serious adverse event occurred during the study will be recorded.
Study 1A
Day 1, 2, 47, 92
Study 1B
1. Changes in glucose and insulin related parameters
i. Fasting plasma glucose FPG mmol/L
ii. Fasting insulin micro IU/mL
iii. Hemoglobin A1c HbA1c %
iv. Homeostatic Model Assessment for Insulin Resistance HOMAIR
v. Homeostasis model assessment of beta-cell function HOMA beta
vi. Disposition index DI
vii. Quantitative insulin sensitivity checks index QUICKI
2. Change in lipid profile
i. Total cholesterol mg/dL
ii. LDL-C mg/dL
iii. HDL-C mg/dL
iv. VLDL-C mg/dL
v. Triglycerides mg/dL
3. Change in vital physical indicators
i. Body temperature
ii. Systolic blood pressure
iii. Diastolic blood pressure
iv. Pulse rate
v. Respiration rate
Study 1B
Day 92, 93, 138, 183
Study 1B
4. Change in hematological parameters
i. Hematological-Complete and differential blood count, platelets.
ii. Biochemical-Serum Glutamic-Oxaloacetic Transaminase, Serum Glutamic Pyruvic Transaminase, serum creatinine, blood urea nitrogen, random blood sugar, total cholesterol, total albumin and globulin and C-Reactive Protein, Thyroid TSH, T3, T4
5. Body Mass Composition Assessment
6. Assessment of tolerability
i. The investigator will evaluate tolerability by asking the subject for any side effects or discomfort.
7. Assessment of Quality of life
i. The quality of life will be assessed during each visit.
8. Adverse events and serious adverse events:
i. Any adverse or Serious adverse event occurred during the study will be recorded.
Study 1B
Day 92, 93, 138, 183
Target Sample Size
Total Sample Size="217" Sample Size from India="217" 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 2
Date of First Enrollment (India)
09/02/2026
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="0" Months="7" Days="0"
Recruitment Status of Trial (Global)
Not Applicable
Recruitment Status of Trial (India)
Closed to Recruitment of Participants
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
The present research is a holistic treatment measure aimed at both the acute weight loss and weight maintenance in the long-term by a well-constructed two-stage treatment program.
The justification of this study is founded on a number of major considerations:
• Phase I - Weight Reduction Phase: The first three months phase aims at realizing clinically significant weight loss by the use of a structured meal replacement program with SlimSEB supplementation and nutritional counseling. This method will satisfy the urgent demand to have effective weight loss but will also provide the behavioral patterns that will prove to be sustainable. The meal replacement method is backed up by massive evidence that depicts that it is more effective in contrast to traditional dietary methods.
• Phase II - Weight Maintenance Phase: The next three-month maintenance period is directly aimed at overcoming the problem of weight loss maintenance by the further SlimSEB supplementation and lifestyle support. This step fills the very important gap in obesity treatment, in which majority of interventions do not perfectly support weight maintenance in the long-run.
• Comprehensive Outcome Assessment: The study protocol will involve the use of several assessment instruments that have been proven to measure the entire range of intervention outcomes such as anthropometric measurements, metabolic parameters, body composition analysis, and quality of life indicators. It is a holistic method that allows assessing the effectiveness and safety of interventions and gives some understanding of how effective weight control works.
• Multi-center Design and Clinical Relevance: The multi-center design increases the extrapolation of the results and facilitates the application of the research results into clinical practice. The research aims to focus on people who are already obese with Class II (BMI 35-45 kg/m 2), a group of people who are already at high risk of obesity related comorbidities and would greatly need effective weight management interventions.
The two-phase design of the study deals with the acute problem of meaningful weight loss and the chronic problem of the maintenance of weight loss with time. The proposed study will advance the study of meal replacement techniques as well as the introduction of new supplementation interventions and support systems to help patients with weight-related health problems and healthcare providers in managing obesity. The strong emphasis on safety tracking, outcome measures, and length-of-follow follow-up qualifies this study to be of great importance in our knowledge of effective weight management strategies and its application in clinical practices. The results of this study could be used in clinical practice, regulatory practices, and eventually lead to the betterment of the lives of obese people in the global community.