Gastroenterology
Conditions
Keywords
Obesity, Weight control, Dai Dai flower
Brief summary
To assess the Dai Dai flower extract on body weight control
Interventions
DIETARY_SUPPLEMENTPlacebo drink
consume 1 bottle (50 mL) per day for 8 weeks
DIETARY_SUPPLEMENTDai Dai flower drink
consume 1 bottle (50 mL) per day for 8 weeks
Sponsors
TCI Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
20 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy male or female aged between 20 and 60 years old * Body mass index (BMI) ≥ 24 (kg/m\^2) or body fat mass ≥ 25%
Exclusion criteria
* Pregnant or breastfeeding woman * Implementation in weight loss programs, consumption drugs or supplements for weight control before 3 months of this study * Participate weight control or fat loss human studies before 3 months of this study * History of cardiovascular disease, liver disease, kidney disease, endocrine disease, or other major organic diseases (according to subjects reporting). * Person who has received major surgery or bariatric surgery (according to medical history). * Person who has received constant drug use. * People with mental illness
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The change of body weight | Change from Baseline body weight at 8 weeks | The body weight (kg) was assessed by InBody. |
| The change of BMI | Change from Baseline BMI at 8 weeks | The BMI was assessed by InBody. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The change of waist-hip ratio | Change from Baseline waist-hip ratio at 8 weeks | The waist-hip ratio was assessed by measuring tape. |
| The change of basal metabolic rate | Change from Baseline basal metabolic rate at 8 weeks | The basal metabolic rate was assessed by InBody. |
| The change of AST | Change from Baseline AST at 8 weeks | Venous blood was sampled to measure concentrations of aspartate transaminase (AST) |
| The change of ALT | Change from Baseline ALT at 8 weeks | Venous blood was sampled to measure concentrations of alanine aminotransferase (ALT) |
| The change of Creatinine | Change from Baseline creatinine at 8 weeks | Venous blood was sampled to measure concentrations of creatinine |
| The change of BUN | Change from Baseline BUN at 8 weeks | Venous blood was sampled to measure concentrations of blood urea nitrogen (BUN) |
| The change of fasting glycemia | Change from Baseline fasting glycemia at 8 weeks | Venous blood was sampled to measure concentrations of fasting glycemia |
| The change of total cholesterol | Change from Baseline total cholesterol at 8 weeks | Venous blood was sampled to measure concentrations of total cholesterol |
| The change of body fat mass | Change from Baseline body fat mass at 8 weeks | The body fat mass (kg) was assessed by InBody. |
| The change of HDL-cholesterol | Change from Baseline HDL-cholesterol at 8 weeks | Venous blood was sampled to measure concentrations of HDL-cholesterol |
| The change of LDL-cholesterol | Change from Baseline LDL-cholesterol at 8 weeks | Venous blood was sampled to measure concentrations of LDL-cholesterol |
| The change of insulin | Change from Baseline insulin at 8 weeks | Venous blood was sampled to measure concentrations of insulin |
| The change of adiponectin | Change from Baseline adiponectin at 8 weeks | Venous blood was sampled to measure concentrations of adiponectin |
| The change of leptin | Change from Baseline leptin at 8 weeks | Venous blood was sampled to measure concentrations of leptin |
| The change of IFN-γ | Change from Baseline IFN-γ at 8 weeks | Venous blood was sampled to measure concentrations of IFN-γ |
| The change of IL-2 | Change from Baseline IL-2 at 8 weeks | Venous blood was sampled to measure concentrations of IL-2 |
| The change of IL-1beta | Change from Baseline IL-1beta at 8 weeks | Venous blood was sampled to measure concentrations of IL-1beta |
| The change of triglyceride | Change from Baseline triglyceride at 8 weeks | Venous blood was sampled to measure concentrations of triglyceride |
| The change of visceral fat mass | Change from Baseline visceral fat mass at 8 weeks | The visceral fat mass (kg) was assessed by InBody. |
Countries
Taiwan
Outcome results
None listed