Efficacy Evaluation of Dai Dai Flower on Body Weight

Not Applicable

Completed

• Conditions: Gastroenterology
• Interventions: Dietary Supplement: Placebo drink; Dietary Supplement: Dai Dai flower drink

• Registration Number: NCT04692792
• Lead Sponsor: TCI Co., Ltd.

Brief Summary

To assess the Dai Dai flower extract on body weight control

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-12-29
• Study First Submitted QC: 2020-12-29
• Study Start: 2021-01-04
• Study First Posted: 2021-01-05
• Primary Completion: 2021-03-06
• Study Completion: 2021-06-15
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-03
• Last Update Posted: 2021-08-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo drink	Placebo drink	-
Dai Dai flower drink	Dai Dai flower drink	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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 leptin	Change from Baseline leptin at 8 weeks	Venous blood was sampled to measure concentrations of leptin
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 visceral fat mass	Change from Baseline visceral fat mass at 8 weeks	The visceral fat mass (kg) was assessed by InBody.
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 triglyceride	Change from Baseline triglyceride at 8 weeks	Venous blood was sampled to measure concentrations of triglyceride
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

Trial Locations

Locations (1)

China Medical University; 🇨🇳 Taichung, Taiwan