A clinical study on effect of GGE03 in overweight subjects
- Conditions
- Health Condition 1: E663- Overweight
- Registration Number
- CTRI/2022/02/040052
- Lead Sponsor
- GENENCELL CO LTD
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
1. Volunteers of either sex, between 18 to 60 years (both inclusive) of age.
2. Volunteers of a body mass index (BMI), between 25.00 kg/m2 to 29.99 kg/m2(both inclusive).
3. Subjects who agree the participation in the trial and submit informed consent before the beginning of the trial.
1.Known history of hypersensitivity to herbal extracts or dietary supplements.
2.Participated in a commercial weight loss program or clinical trial for obesity/overweight within the last three months.
3.Intentional weight loss of at least 5% within 3 months prior to screening.
4.Any history of surgery such as gastroplasty and intestinal resection, to lose weight within 6 months prior to screening.
5.Consuming drugs or diet foods that affect their weight within 3 months prior to screening.
6.Psychologically significant medical history or current disease (schizophrenia, epilepsy, anorexia, bulimia, etc.), or a history of alcohol or the other drug abuse.
7.Severe cerebrovascular disease (cerebral infarction, cerebral hemorrhage etc.), heart disease (angina pectoris, myocardial infarction, heart failure, arrhythmia in need of treatment), lung disease (chronic obstructive pulmonary disease, etc.) within the last 6 months.
8. Endocrine diseases such as hypothyroidism, PCOD and Cushings syndrom.
9.Fasting blood glucose � 126 mg/dL or random blood glucose � 200 mg/dL, or diabetic patients taking oral hypoglycaemic agents or insulin.
10.Serious dysfunction of liver (alanine and aspartate aminotransferase levels of 2.5 times the upper limit or normal) or kidney (creatinine > 2.0 mg/dL).
11.Signs or symptoms of severe gastrointestinal symptoms such as heartburn and indigestion.
12.Use of drugs (absorbent laxatives and appetite suppressants, health function foods/supplements related to obesity improvement, psychotropic drugs such as anti-depressants, beta-blockers, diuretics, contraceptives, steroids and female hormones) that affect his or her body weight in the last one month or less.
13.Unable to exercise due to musculoskeletal disease.
14.A female who is breastfeeding or pregnant or planning for pregnancy during this study period.
15.Subject judged as unfit for study by PI.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1.Body fat rate by DEXA (Dual-energy X-ray absorptiometry) <br/ ><br>2.Body fat amount by DEXA (Dual-energy X-ray absorptiometry). <br/ ><br>Timepoint: Baseline and 12 weeks <br/ ><br>
- Secondary Outcome Measures
Name Time Method 1.Weight <br/ ><br>2.Waist Circumference <br/ ><br>3.Hip Circumference <br/ ><br>4.Waist to Hip Ratio <br/ ><br>5.Body Mass Index (BMI) <br/ ><br>6.Lean Mass by DEXA (Dual-energy X-ray absorptiometry) <br/ ><br>7.Total Cholesterol <br/ ><br>8.HDL-Cholesterol <br/ ><br>9.LDL-Cholesterol <br/ ><br>10.Triglyceride <br/ ><br>11.Visceral Fat Area <br/ ><br>12.Subcutaneous Fat Area <br/ ><br>13.Total Fat Area <br/ ><br>14.AdiponectinTimepoint: Baseline and 12 weeks