None listed
Conditions
Interventions
Intervention1: Each Capsule having 375mg of CornfitTM and 125mg of Microcrystalline Cellulose(MCC): 2 Capsules per day in the morning after breakfast for (84+3) days
Control Intervention1: Each Capsul
Sponsors
Botanic Healthcare Pvt. Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1.Adult males and non-pregnant females aged 19 to 65 years 2.Individuals with a BMI of 25-32kg/m2 who are not taking any obesity related medicines. 3. Able to comply with all required study procedures and schedule. 4. Able to comply and willing to follow the prescribed diet plan. 5. Willing and able to give written informed consent.
Exclusion criteria
Exclusion criteria: 1.Individuals who experienced a weight change of 5% or more within 3 months prior to the screening. 2.Individuals who have taken or used medications, herbal remedies, or health supplements (including probiotics) for anti- obesity purposes (e.g., energy metabolism, appetite suppression, weight control, fat breakdown, carbohydrate blocking, inhibition of fat absorption, or gastrointestinal activity regulation) within 6 months prior to the screening. 3. Individuals who have participated in or experienced a weight-loss program within 3 months prior to the screening. 4. Individuals with Gastrointestinal disease like Crohn’s Disease, Inflammatory Bowel Syndrome, Gastric resection, Chronic Inflammation (Kidney, Liver, Pancreas), infectious diseases, Autoimmune diseases, Malabsorption syndrome, Porphyria, Hepatitis B or C carriers. 5. Individuals currently using immunosuppressants; proton pump inhibitors (PPIs), H2 receptor blockers, or nonsteroidal anti-inflammatory drugs (NSAIDs); insulin; thyroid hormone replacement therapy. 6. Individuals who have taken Appetite suppressants, Semaglutide, OTC weight loss supplements 3 to 6 months before the trial. 7. Individuals who have consistently consumed dietary supplements (including protein supplements), teas, beverages, or jellies for weight control or fat reduction purposes. 8. Individuals who have undergone any obesity surgery or any surgery within the last 6 months. 9. Individuals who have consistently taken medications or health supplements for cholesterol improvement or blood circulation enhancement within 6 months prior to the screening. 10. Individuals who have clinically significant diseases or disorders related to the liver, kidneys, pancreas, biliary system, cardiovascular system, respiratory system, endocrine system (e.g., diabetes, thyroid disorders), or central nervous system, or who have malignant tumors as identified in physical or clinical examinations (except those who have not experienced recurrence for over 5 years post-surgery). 11. Individuals with uncontrolled hypertension (systolic blood pressure greater or equal to 160 mmHg or diastolic blood pressure greater or equal to 100 mmHg). 12. Individuals diagnosed with diabetes and taking medications to control blood sugar. 13. Individuals undergoing psychiatric medication or psychotherapy for eating disorders or other mental disorders. 14. Individuals with a history of clinically significant hypersensitivity reactions or those who may exhibit hypersensitivity to the ingredients or similar components of the investigational product. 15. Individuals who have consistently used functional products for cellulite removal or fat breakdown. 16.Heavy smokers (greater or equal to 20 cigarettes/day). 17. Individuals who excessively consume alcohol (greater or equal to 40 g/day for men or greater or equal to20 g/day for women). 18. Individuals whose diagnostic or medical test results at the screening visit show the following AST, ALT, or gamma GTP levels exceeding three times the upper limit of the laboratory reference range. eGFR less 60 mL/min/1.73 m square. 19. Individuals w
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| •To evaluate the efficacy of the product in reducing the body fat mass and body fat percentage by area (Whole body, arms, legs, trunk, android and gynoid) assessed using dual energy X-ray absorptiometry (DEXA) at 12 weeks from baselineTimepoint: Day 0, Day 1, Day 42, Day 84 | — |
Secondary
| Measure | Time frame |
|---|---|
| •To evaluate the lean mass percentage by DEXA scan at 12 weeks from baseline. •Changes in total fat area, subcutaneous fat area, visceral fat area by Abdominal CT at 12 weeks from baseline. •Changes in body weight, body mass index (BMI), waist circumference, hip circumference, waist/hip circumference ratio at 6 and 12 weeks from baseline. •Changes in blood lipid concentrations (total cholesterol, low- density lipoprotein (LDL)-cholesterol, triglyceride (TG), and high- density lipoprotein (HDL)-cholesterol), leptin, and adiponectin, serum insulin and GLP-1 at 12 weeks from Baseline. •Changes in Basal Metabolic Rate at 12 weeks from Baseline. •Change in HbA1c at Visit 01 and Visit 04. Timepoint: Day 0, Day 1, Day 42, Day 84 | — |
Countries
India
Contacts
Public ContactDivya Chandradhar
Botanic Healthcare Private Limited
Outcome results
None listed