Efficacy Evaluation of Dai Dai Flower on Body Weight

Study Overview
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Brief Summary
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To assess the Dai Dai flower extract on body weight control

Official Title
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Efficacy Evaluation of Dai Dai Flower on Body Weight

Conditions
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Gastroenterology

Intervention / Treatment
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* Dietary Supplement: Placebo drink
* Dietary Supplement: Dai Dai flower drink


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo drink<br> | Dietary Supplement: Placebo drink<br>* consume 1 bottle (50 mL) per day for 8 weeks<br>|
| Experimental: Dai Dai flower drink<br> | Dietary Supplement: Dai Dai flower drink<br>* consume 1 bottle (50 mL) per day for 8 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change of body weight | The body weight (kg) was assessed by InBody. | Change from Baseline body weight at 8 weeks | 
| The change of BMI | The BMI was assessed by InBody. | Change from Baseline BMI at 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change of body fat mass | The body fat mass (kg) was assessed by InBody. | Change from Baseline body fat mass at 8 weeks | 
| The change of visceral fat mass | The visceral fat mass (kg) was assessed by InBody. | Change from Baseline visceral fat mass at 8 weeks | 
| The change of waist-hip ratio | The waist-hip ratio was assessed by measuring tape. | Change from Baseline waist-hip ratio at 8 weeks | 
| The change of basal metabolic rate | The basal metabolic rate was assessed by InBody. | Change from Baseline basal metabolic rate at 8 weeks | 
| The change of AST | Venous blood was sampled to measure concentrations of aspartate transaminase (AST) | Change from Baseline AST at 8 weeks | 
| The change of ALT | Venous blood was sampled to measure concentrations of alanine aminotransferase (ALT) | Change from Baseline ALT at 8 weeks | 
| The change of Creatinine | Venous blood was sampled to measure concentrations of creatinine | Change from Baseline creatinine at 8 weeks | 
| The change of BUN | Venous blood was sampled to measure concentrations of blood urea nitrogen (BUN) | Change from Baseline BUN at 8 weeks | 
| The change of fasting glycemia | Venous blood was sampled to measure concentrations of fasting glycemia | Change from Baseline fasting glycemia at 8 weeks | 
| The change of total cholesterol | Venous blood was sampled to measure concentrations of total cholesterol | Change from Baseline total cholesterol at 8 weeks | 
| The change of triglyceride | Venous blood was sampled to measure concentrations of triglyceride | Change from Baseline triglyceride at 8 weeks | 
| The change of HDL-cholesterol | Venous blood was sampled to measure concentrations of HDL-cholesterol | Change from Baseline HDL-cholesterol at 8 weeks | 
| The change of LDL-cholesterol | Venous blood was sampled to measure concentrations of LDL-cholesterol | Change from Baseline LDL-cholesterol at 8 weeks | 
| The change of insulin | Venous blood was sampled to measure concentrations of insulin | Change from Baseline insulin at 8 weeks | 
| The change of adiponectin | Venous blood was sampled to measure concentrations of adiponectin | Change from Baseline adiponectin at 8 weeks | 
| The change of leptin | Venous blood was sampled to measure concentrations of leptin | Change from Baseline leptin at 8 weeks | 
| The change of IFN-γ | Venous blood was sampled to measure concentrations of IFN-γ | Change from Baseline IFN-γ at 8 weeks | 
| The change of IL-2 | Venous blood was sampled to measure concentrations of IL-2 | Change from Baseline IL-2 at 8 weeks | 
| The change of IL-1beta | Venous blood was sampled to measure concentrations of IL-1beta | Change from Baseline IL-1beta at 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Obesity, Weight control, Dai Dai flower