Clinical trial NCT04692792: Efficacy Evaluation of Dai Dai Flower on Body Weight
Official title: Efficacy Evaluation of Dai Dai Flower on Body Weight
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gastroenterology
Keywords: Obesity
Weight control
Dai Dai flower
Lead sponsor: TCI Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2021-01-05
Enrollment: 50
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: To assess the Dai Dai flower extract on body weight control


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

Primary outcomes:
measure: The change of body weight
timeFrame: Change from Baseline body weight at 8 weeks
measure: The change of BMI
timeFrame: Change from Baseline BMI at 8 weeks
Secondary outcomes:
measure: The change of body fat mass
timeFrame: Change from Baseline body fat mass at 8 weeks
measure: The change of visceral fat mass
timeFrame: Change from Baseline visceral fat mass at 8 weeks
measure: The change of waist-hip ratio
timeFrame: Change from Baseline waist-hip ratio at 8 weeks
measure: The change of basal metabolic rate
timeFrame: Change from Baseline basal metabolic rate at 8 weeks
measure: The change of AST
timeFrame: Change from Baseline AST at 8 weeks
measure: The change of ALT
timeFrame: Change from Baseline ALT at 8 weeks
measure: The change of Creatinine
timeFrame: Change from Baseline creatinine at 8 weeks
measure: The change of BUN
timeFrame: Change from Baseline BUN at 8 weeks
measure: The change of fasting glycemia
timeFrame: Change from Baseline fasting glycemia at 8 weeks
measure: The change of total cholesterol
timeFrame: Change from Baseline total cholesterol at 8 weeks
measure: The change of triglyceride
timeFrame: Change from Baseline triglyceride at 8 weeks
measure: The change of HDL-cholesterol
timeFrame: Change from Baseline HDL-cholesterol at 8 weeks
measure: The change of LDL-cholesterol
timeFrame: Change from Baseline LDL-cholesterol at 8 weeks
measure: The change of insulin
timeFrame: Change from Baseline insulin at 8 weeks
measure: The change of adiponectin
timeFrame: Change from Baseline adiponectin at 8 weeks
measure: The change of leptin
timeFrame: Change from Baseline leptin at 8 weeks
measure: The change of IFN-γ
timeFrame: Change from Baseline IFN-γ at 8 weeks
measure: The change of IL-2
timeFrame: Change from Baseline IL-2 at 8 weeks
measure: The change of IL-1beta
timeFrame: Change from Baseline IL-1beta at 8 weeks
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: China Medical University
Study officials:
affiliation: China Medical University, China
name: Hsiu-Mei Chiang, Prof.
role: PRINCIPAL_INVESTIGATOR
References: