Efficacy Evaluation of Dai Dai Flower on Body Weight

Gastroenterology Clinical Trial

Official title:

Efficacy Evaluation of Dai Dai Flower on Body Weight

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04692792
• Other study ID #: CMUH109-REC1-161
• Status: Completed
• Phase: N/A
• Start date: January 4, 2021
• Est. completion date: June 15, 2021

Study information

• Verified date: August 2021
• Source: TCI Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To assess the Dai Dai flower extract on body weight control

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: June 15, 2021
• Est. primary completion date: March 6, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Body Weight
• Gastroenterology

Intervention

Dietary Supplement:
• Placebo drink
consume 1 bottle (50 mL) per day for 8 weeks
• Dai Dai flower drink
consume 1 bottle (50 mL) per day for 8 weeks

Locations

Country	Name	City	State
Taiwan	China Medical University	Taichung

Sponsors (1)

Lead Sponsor	Collaborator
TCI Co., Ltd.

Country where clinical trial is conducted

Taiwan, 

Outcome

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