Back to resultsEfficacy Evaluation of Dai Dai Flower on Body Weight
Primary Purpose
Gastroenterology
Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Placebo drink
Dai Dai flower drink
Sponsored by
About this trial
This is an interventional other trial for Gastroenterology focused on measuring Obesity, Weight control, Dai Dai flower
Eligibility Criteria
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
Sites / Locations
- China Medical University
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Placebo drink
Dai Dai flower drink
Arm Description
Outcomes
Primary Outcome Measures
The change of body weight
The body weight (kg) was assessed by InBody.
The change of BMI
The BMI was assessed by InBody.
Secondary Outcome Measures
The change of body fat mass
The body fat mass (kg) was assessed by InBody.
The change of visceral fat mass
The visceral fat mass (kg) was assessed by InBody.
The change of waist-hip ratio
The waist-hip ratio was assessed by measuring tape.
The change of basal metabolic rate
The basal metabolic rate was assessed by InBody.
The change of AST
Venous blood was sampled to measure concentrations of aspartate transaminase (AST)
The change of ALT
Venous blood was sampled to measure concentrations of alanine aminotransferase (ALT)
The change of Creatinine
Venous blood was sampled to measure concentrations of creatinine
The change of BUN
Venous blood was sampled to measure concentrations of blood urea nitrogen (BUN)
The change of fasting glycemia
Venous blood was sampled to measure concentrations of fasting glycemia
The change of total cholesterol
Venous blood was sampled to measure concentrations of total cholesterol
The change of triglyceride
Venous blood was sampled to measure concentrations of triglyceride
The change of HDL-cholesterol
Venous blood was sampled to measure concentrations of HDL-cholesterol
The change of LDL-cholesterol
Venous blood was sampled to measure concentrations of LDL-cholesterol
The change of insulin
Venous blood was sampled to measure concentrations of insulin
The change of adiponectin
Venous blood was sampled to measure concentrations of adiponectin
The change of leptin
Venous blood was sampled to measure concentrations of leptin
The change of IFN-γ
Venous blood was sampled to measure concentrations of IFN-γ
The change of IL-2
Venous blood was sampled to measure concentrations of IL-2
The change of IL-1beta
Venous blood was sampled to measure concentrations of IL-1beta
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04692792
Brief Title
Efficacy Evaluation of Dai Dai Flower on Body Weight
Official Title
Efficacy Evaluation of Dai Dai Flower on Body Weight
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
January 4, 2021 (Actual)
Primary Completion Date
March 6, 2021 (Actual)
Study Completion Date
June 15, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
TCI Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
To assess the Dai Dai flower extract on body weight control
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastroenterology
Keywords
Obesity, Weight control, Dai Dai flower
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo drink
Arm Type
Placebo Comparator
Arm Title
Dai Dai flower drink
Arm Type
Experimental
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo drink
Intervention Description
consume 1 bottle (50 mL) per day for 8 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
Dai Dai flower drink
Intervention Description
consume 1 bottle (50 mL) per day for 8 weeks
Primary Outcome Measure Information:
Title
The change of body weight
Description
The body weight (kg) was assessed by InBody.
Time Frame
Change from Baseline body weight at 8 weeks
Title
The change of BMI
Description
The BMI was assessed by InBody.
Time Frame
Change from Baseline BMI at 8 weeks
Secondary Outcome Measure Information:
Title
The change of body fat mass
Description
The body fat mass (kg) was assessed by InBody.
Time Frame
Change from Baseline body fat mass at 8 weeks
Title
The change of visceral fat mass
Description
The visceral fat mass (kg) was assessed by InBody.
Time Frame
Change from Baseline visceral fat mass at 8 weeks
Title
The change of waist-hip ratio
Description
The waist-hip ratio was assessed by measuring tape.
Time Frame
Change from Baseline waist-hip ratio at 8 weeks
Title
The change of basal metabolic rate
Description
The basal metabolic rate was assessed by InBody.
Time Frame
Change from Baseline basal metabolic rate at 8 weeks
Title
The change of AST
Description
Venous blood was sampled to measure concentrations of aspartate transaminase (AST)
Time Frame
Change from Baseline AST at 8 weeks
Title
The change of ALT
Description
Venous blood was sampled to measure concentrations of alanine aminotransferase (ALT)
Time Frame
Change from Baseline ALT at 8 weeks
Title
The change of Creatinine
Description
Venous blood was sampled to measure concentrations of creatinine
Time Frame
Change from Baseline creatinine at 8 weeks
Title
The change of BUN
Description
Venous blood was sampled to measure concentrations of blood urea nitrogen (BUN)
Time Frame
Change from Baseline BUN at 8 weeks
Title
The change of fasting glycemia
Description
Venous blood was sampled to measure concentrations of fasting glycemia
Time Frame
Change from Baseline fasting glycemia at 8 weeks
Title
The change of total cholesterol
Description
Venous blood was sampled to measure concentrations of total cholesterol
Time Frame
Change from Baseline total cholesterol at 8 weeks
Title
The change of triglyceride
Description
Venous blood was sampled to measure concentrations of triglyceride
Time Frame
Change from Baseline triglyceride at 8 weeks
Title
The change of HDL-cholesterol
Description
Venous blood was sampled to measure concentrations of HDL-cholesterol
Time Frame
Change from Baseline HDL-cholesterol at 8 weeks
Title
The change of LDL-cholesterol
Description
Venous blood was sampled to measure concentrations of LDL-cholesterol
Time Frame
Change from Baseline LDL-cholesterol at 8 weeks
Title
The change of insulin
Description
Venous blood was sampled to measure concentrations of insulin
Time Frame
Change from Baseline insulin at 8 weeks
Title
The change of adiponectin
Description
Venous blood was sampled to measure concentrations of adiponectin
Time Frame
Change from Baseline adiponectin at 8 weeks
Title
The change of leptin
Description
Venous blood was sampled to measure concentrations of leptin
Time Frame
Change from Baseline leptin at 8 weeks
Title
The change of IFN-γ
Description
Venous blood was sampled to measure concentrations of IFN-γ
Time Frame
Change from Baseline IFN-γ at 8 weeks
Title
The change of IL-2
Description
Venous blood was sampled to measure concentrations of IL-2
Time Frame
Change from Baseline IL-2 at 8 weeks
Title
The change of IL-1beta
Description
Venous blood was sampled to measure concentrations of IL-1beta
Time Frame
Change from Baseline IL-1beta at 8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hsiu-Mei Chiang, Prof.
Organizational Affiliation
China Medical University, China
Official's Role
Principal Investigator
Facility Information:
Facility Name
China Medical University
City
Taichung
ZIP/Postal Code
404
Country
Taiwan
12. IPD Sharing Statement
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Efficacy Evaluation of Dai Dai Flower on Body Weight
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