None listed
Conditions
Interventions
Intervention1: Gymnema extract (Melitwocut ): Dose :500mg,
Doasge form: Capusle, 1 capsule before breakfast and 1 capsule before dinner,
Total Duration 84days,
Control Intervention1: Placebo: Dose :
Sponsors
CELL GREEN BIOLAB Co Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1.Adult males and non-pregnant females aged 19 to 60 years. 2.Those who belong to the range of BMI 25 kg per m2 to 32 kg per m2 and who do not take weight loss medications, appetite suppressants, or medications that significantly affect metabolism. If individuals with a BMI between 30.0 and 32.0 kg per m are included (within ethically permissible limits) those who are currently taking medication or require a prescription must be strictly excluded). 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: A. Medication Use 1. Anti-obesity drugs / Drug addiction / Blood sugar-lowering agents, insulin, diabetes medication / Diuretics / Corticosteroids, antidepressants, anticonvulsants / Hormonal contraceptives (women) / Subcutaneous injections within the past year (heparin, insulin) / Medications affecting energy metabolism, blood glucose, appetite, gastrointestinal activity / Medications affecting carbohydrate and lipid metabolism, body weight, and hormones / Immunosuppressants, proton pump inhibitors, H2 blockers, non-steroidal anti-inflammatory drugs (NSAIDs) B. Disease Condition 2. Obesity surgery within the past year / Any surgery within the past 6 months / Mental disorders (depression, schizophrenia), psychological therapy / Cardiovascular diseases / Arrhythmia / Heart failure / Myocardial infarction / History of using a pacemaker / Diabetic patients who are on medication or whose condition is not controlled / Gastrointestinal disorders (Crohn s disease) / Gastrectomy / Irritable bowel syndrome / Liver failure / Renal failure / Malabsorption syndrome / Autoimmune diseases / Cancer / Thyroid or hormonal disorders / Abnormal thyroid hormone levels / Diseases that may affect body weight / Individuals with compromised immune systems / Anemia, porphyria / Pancreatic diseases / Cerebrovascular diseases / History of eating disorders 3.Individuals with thyroid stimulating hormone (TSH) levels outside the institution s normal range 4.Individuals with eGFR Less than 60 mL/min/1.73m 5.Individuals with ALT or AST levels more than three times the upper limit of normal C. Other General Conditions (Physiological, Lifestyle and Allergic Reactions etc.) 6. 5 10 percent weight change within 3 months or Weight gain or loss of more than 5 kg 7. Individuals currently on a diet for the past few years or those who participated in a weight loss program within the past 3 months 8.Pregnant or lactating women, or those planning pregnancy 9.Individuals with allergies or adverse reactions to the test substance 10.Alcohol consumption-Men greater than or equal to 40 g per day, Women greater than or equal to 20 g per day (based on WHO daily alcohol intake guidelines)] 11.Heavy smokers- greater than or equal to 20 cigarettes per day 12.Individuals who have taken health functional foods and medications related to the specific functionality being tested within 3 months prior to the study start 13.Individuals who participated in other clinical trials within the past 3 months 14.Individuals deemed unsuitable for this study at the discretion of the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Changes in body fat mass (g) 2. Changes in body fat percentage 3. Changes in dual-energy X-ray absorptiometry (DEXA) Timepoint: Day 0 to Day 84 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Changes in lean mass (g) and body fat mass (g) by area (trunk, android, gynoid, etc.), body fat percentage (%) by area (trunk, android, gynoid, etc.), and lean mass (g) by area (trunk, android, gynoid, etc.) assessed using DEXA (Day 0 to Day 84) 2.Changes in total fat area, subcutaneous fat area, visceral fat area, and visceral fat area/subcutaneous fat area ratio measured using abdominal computed tomography (CT)(Day 0 and Day 84) 3.Changes in body weight, body mass index (BMI), waist circumference, hip circumference, calf circumference, mid-upper arm circumference (MUAC), waist/hip circumference ratio 4.Changes in blood lipid concentrations (total cholesterol, low-density lipoprotein (LDL)-cholesterol, triglyceride (TG), and high-density lipoprotein (HDL)-cholesterol) Timepoint: Screening visit , Day 28 ,56,84;5.Biomarkers -leptin, and adiponectin 6.Safety assessments- CBC, Electrolyte test Complete Biochemistry test- LFT, RFT, Thyroid profile Timepoint: Screening visit and Day 84 | — |
Countries
India
Contacts
Public ContactDr Ashok Godavarthi
Radiant Research Services Pvt Ltd
Outcome results
None listed