Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study was conducted to investigate the effects of daily supplementation of GTB1 on decrease of body fat.
This study was a 12 week, randomized, double-blind, placebo-controlled human trial. 100 subjects were randomly divided into GTB1 group and placebo group. It is to evaluate the changes in the displayed evaluation items when taking GTB1 once a day, in comparison with taking a placebo.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GTB1 | Active Comparator | Once-daily, once a packet, for 12 week |
|
| Placebo | Placebo Comparator | Once-daily, once a packet, for 12 week |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GTB1 | Dietary Supplement | oral administration of GTB1 powder packet once daily |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Changes of percent body fat(trunk, total ect.) | Measurement is made using dual-energy X-ray absorptiometry(DEXA) | Baseline, Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Changes of fat free mass(trunk, total ect.) | Measurement of the target area is made using dual-energy X-ray absorptiometry (DEXA) | Baseline, Week 12 |
| Changes of total abdominal fat area, visceral fat area and subcutaneous fat area |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Participants who decrease 10% more of weight within 3 months period to the screening
Participants who have undergone surgical procedures (such as gastrectomy) for weight loss
Participants who have a history of malignant tumors within 5 years prior to participating in the clinical study
Participants who have a systolic blood pressure of 160 mmHg or higher, or a diastolic blood pressure of 100 mmHg or higher (those who are stably controlling their blood pressure with medication can participate)
Participants who are taking beta-blockers or diuretics as part of their hypertension treatment
Patients who have been diagnosed with Type 1 or Type 2 diabetes and are taking oral hypoglycemic agents and insulin
Participants who have taken antibiotics within 4 weeks prior to the screening examination
Participants who have taken health functional foods, herbal medicine, or general foods for the purpose of weight loss within 4 weeks prior to the screening visit
Participants with clinically significant acute or chronic diseases of the cardiovascular system, endocrine system, immune system, respiratory system, liver biliary system, kidney and urinary system, neuropsychiatry system, musculoskeletal system, inflammatory and hematologic, gastrointestinal diseases, and other diseases requiring treatment
Participants with a past history of gastrointestinal diseases (e.g., Crohn's disease) or gastrointestinal surgery (but, excluding simple cecal surgery and hernia surgery) that can affect the absorption of products of the human trial
Participants who have participated in other clinical study within 3 months prior to the screening examination
Women who are pregnant or breastfeeding
Women who may become pregnant and have not used appropriate contraceptives
Participants who show the following relevant results in a Laboratory test
Participants who the principal investigator judged inappropriate for the participant in this study because of a laboratory test result, etc.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jeonbuk National University Hospital | Jeonju | Jeollabuk-do | South Korea |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo |
| Dietary Supplement |
oral administration of placebo powder packet once daily |
|
Measurement of the target area is made using computed tomography (CT)
| Baseline, Week 12 |
| Changes of waist, hip circumference and waist/hip circumference ratio | Measurement of waist and hip circumference is performed following the WHO guideline | Baseline, Week 12 |
| Changes of indicator of lipid metabolism | Indicator of lipid metabolism(i.e., Total cholesterol, Triglyceride, LDL-cholesterol, HDL-cholesterol) | Baseline, Week 12 |
| Changes of obesity-related hormone index | Obesity-related hormone indexes(Adiponectin, Leptin etc.). As blood adiponectin levels increase, blood leptin concentrations decrease, indicating a positive change. | Baseline, Week 12 |