None listed
Conditions
Interventions
Intervention1: Fitnema derived from Gymnema sylvestre extract: One capsule of 450mg Fitnema derived from Gymnema Sylvestre Extract test product (which contains 300 mg of Gymnema extract) taken orally
Sponsors
ADL HOLDINGS
Botanic Healthcare Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1) Adults aged between 19 and 65 are healthy and capable of normal physical activity. 2) Adults who belong to the range of BMI 25 to 34.9kg/m2 and do not take drugs. 3) Adults who voluntarily decide to participate and agree in writing to abide by the precautions after hearing a detailed explanation of the clinical study and fully understand it.
Exclusion criteria
Exclusion criteria: 1) Adults who did not sign the research subject consent form. 2) Adults who participated in other clinical studies within 2 months before the screening test. 3) Subjects whose body weight has changed by 5-10 percent and whose weight gain/loss is 5kg or more within 3 months. 4) Subjects who have undergone obesity surgery within the last year 5) Subjects who have undergone surgery within the last 6 months 6) Subjects who are receiving or receiving psychotropic drug treatment and psychological treatment due to mental disorders (depression, schizophrenia) 7) Subjects with cardiovascular disease, arrhythmia, heart failure, myocardial infarction, cerebrovascular disease, and those with a history of using a cardiac pacemaker 8) Subjects with diabetes who are under medication or cannot be controlled 9) Gastrointestinal disease (Crohn s disease)/gastric resection/irritable bowel syndrome. 10) Chronic inflammation (kidney, liver, pancreas) and infectious diseases, hypertension (systolic/diastolic 160/100mmHg or more). 11) Subjects with a history of heart disease or cancer. 12) Subjects with thyroid disease or those taking thyroid drug substitutes. 13) Subjects with malabsorption syndrome/ autoimmune disease. 14) Subjects with liver and kidney failure. 15) Subjects taking dietary supplements or drugs that may affect blood sugar and lipid metabolism, body composition, and eicosanoid production (e.g., salicylates, dairy products). 16) Subjects with anemia/ porphyria. 17) Subjects suffering from pancreatic disease, those with a history of eating disorders. 18) Women who are pregnant or lactating. 19) Women within 6 months of giving birth. 20) Subjects taking anti-obesity drugs. 21) Drug addicted subjects. 22) Subjects who are taking blood sugar lowering drugs, insulin, or diabetes medications. 23) Subjects who are taking drugs that affect energy metabolism, blood sugar, appetite, and gastrointestinal activity. 24) Subjects taking medications that affect carbohydrate and lipid metabolism, weight and hormones. 25) Subjects taking immunosuppressants, PPI, H2 blockers, and non-steroidal anti-inflammatory drugs. 26) Subjects who are taking health functional food products for reducing body fat. 27) Women who do not use the correct method of contraception. 28) Subjects who have been on weight management for the past few years. 29) Subjects who have participated in a weight loss program within the last 3 months. 30) Subjects who consume excessive alcohol or Ingested alcohol content (2g/day): [Intake (ml) multiply by alcohol content (percent) multiply by 0.8 (alcohol specific gravity) by 100. 31) Excessive smokers (more than 25 cigarettes per day). 32) Subjects with allergies or side effects to the test substance etc. 33) Subjects with serum creatinine 1.5mg/dL or higher. 34) Subject whose AST (aspartate aminotransferase) and ALT (alanine aminotransferase) level is three times or more than the maximum normal level 35) Subject who is judged unsuitable for the human application test by the researcher. 36) Hepatitis B or C carriers. Subjects who are judged unfit to participate in the research by the research director due to other reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in body fat mass (kg) and body Fat percentage by using DEXATimepoint: Day 0 (baseline) and Week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in Body WeightTimepoint: Day 0 (baseline), Week 6 and Week 12;Change in Waist circumference, Hip circumference, WHR (waist/hip ratio)Timepoint: Day 0 (baseline), Week 6 and Week 12;Change in BMITimepoint: Day 0 (baseline), Week 6 and Week 12;Change in Lean body mass by using DEXATimepoint: Day 0 (baseline) and Week 12;Change in Abdominal visceral fat and subcutaneous fat area- by CTTimepoint: Day 0 (baseline) and Week 12;Chane in Blood LipidTimepoint: Day 0 (baseline) and week 12;Change in Adiponectin, Leptin and InsulinTimepoint: Day 0 (baseline) and week 12;Change in Basal metabolic rateTimepoint: Day 0 (baseline), Week 6 and Week 12 | — |
Countries
India
Contacts
Public ContactT Sravani
Botanic Healthcare Pvt. Ltd.
Outcome results
None listed