Efficacy Evaluation of Dai Dai Flower on Body Weight

To assess the Dai Dai flower extract on body weight control

Study Overview

• Status: Completed
• Conditions: Gastroenterology
• Intervention / Treatment: Dietary supplement: Placebo drink; Dietary supplement: Dai Dai flower drink

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taichung, Taiwan, 404
    • China Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo drink	Dietary supplement: Placebo drink; consume 1 bottle (50 mL) per day for 8 weeks
Experimental: Dai Dai flower drink	Dietary supplement: Dai Dai flower drink; consume 1 bottle (50 mL) per day for 8 weeks

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: TCI Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): January 4, 2021
• Primary Completion (Actual): March 6, 2021
• Study Completion (Actual): June 15, 2021

Study Registration Dates

• First Submitted: December 29, 2020
• First Submitted That Met QC Criteria: December 29, 2020
• First Posted (Actual): January 5, 2021

Study Record Updates

• Last Update Posted (Actual): August 4, 2021
• Last Update Submitted That Met QC Criteria: August 3, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: Obesity; Weight control; Dai Dai flower
• Additional Relevant MeSH Terms: Body Weight
• Other Study ID Numbers: CMUH109-REC1-161

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No