Efficacy Evaluation of Dai Dai Flower on Body Weight

• Sponsor: TCI Co., Ltd. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04692792
• Collaborator: (none)
• Enrollment: 50
• Location: 1
• Arms: 2
• Actual Duration (Months): 5.3
• Patients Per Site Per Month: 9.4

Study Details

Study Description

Brief Summary

To assess the Dai Dai flower extract on body weight control

Condition or Disease	Intervention/Treatment	Phase
Gastroenterology	Dietary Supplement: Placebo drink; Dietary Supplement: Dai Dai flower drink	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 50 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Other
• Official Title: Efficacy Evaluation of Dai Dai Flower on Body Weight
• Actual Study Start Date: Jan 4, 2021
• Actual Primary Completion Date: Mar 6, 2021
• Actual Study Completion Date: Jun 15, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. The change of body weight [Change from Baseline body weight at 8 weeks]

   The body weight (kg) was assessed by InBody.

2. The change of BMI [Change from Baseline BMI at 8 weeks]

   The BMI was assessed by InBody.

Secondary Outcome Measures

1. The change of body fat mass [Change from Baseline body fat mass at 8 weeks]

   The body fat mass (kg) was assessed by InBody.

2. The change of visceral fat mass [Change from Baseline visceral fat mass at 8 weeks]

   The visceral fat mass (kg) was assessed by InBody.

3. The change of waist-hip ratio [Change from Baseline waist-hip ratio at 8 weeks]

   The waist-hip ratio was assessed by measuring tape.

4. The change of basal metabolic rate [Change from Baseline basal metabolic rate at 8 weeks]

   The basal metabolic rate was assessed by InBody.

5. The change of AST [Change from Baseline AST at 8 weeks]

   Venous blood was sampled to measure concentrations of aspartate transaminase (AST)

6. The change of ALT [Change from Baseline ALT at 8 weeks]

   Venous blood was sampled to measure concentrations of alanine aminotransferase (ALT)

7. The change of Creatinine [Change from Baseline creatinine at 8 weeks]

   Venous blood was sampled to measure concentrations of creatinine

8. The change of BUN [Change from Baseline BUN at 8 weeks]

   Venous blood was sampled to measure concentrations of blood urea nitrogen (BUN)

9. The change of fasting glycemia [Change from Baseline fasting glycemia at 8 weeks]

   Venous blood was sampled to measure concentrations of fasting glycemia

10. The change of total cholesterol [Change from Baseline total cholesterol at 8 weeks]

    Venous blood was sampled to measure concentrations of total cholesterol

11. The change of triglyceride [Change from Baseline triglyceride at 8 weeks]

    Venous blood was sampled to measure concentrations of triglyceride

12. The change of HDL-cholesterol [Change from Baseline HDL-cholesterol at 8 weeks]

    Venous blood was sampled to measure concentrations of HDL-cholesterol

13. The change of LDL-cholesterol [Change from Baseline LDL-cholesterol at 8 weeks]

    Venous blood was sampled to measure concentrations of LDL-cholesterol

14. The change of insulin [Change from Baseline insulin at 8 weeks]

    Venous blood was sampled to measure concentrations of insulin

15. The change of adiponectin [Change from Baseline adiponectin at 8 weeks]

    Venous blood was sampled to measure concentrations of adiponectin

16. The change of leptin [Change from Baseline leptin at 8 weeks]

    Venous blood was sampled to measure concentrations of leptin

17. The change of IFN-γ [Change from Baseline IFN-γ at 8 weeks]

    Venous blood was sampled to measure concentrations of IFN-γ

18. The change of IL-2 [Change from Baseline IL-2 at 8 weeks]

    Venous blood was sampled to measure concentrations of IL-2

19. The change of IL-1beta [Change from Baseline IL-1beta at 8 weeks]

    Venous blood was sampled to measure concentrations of IL-1beta

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	China Medical University	Taichung		Taiwan	404

Sponsors and Collaborators

• TCI Co., Ltd.

Investigators

• Principal Investigator: Hsiu-Mei Chiang, Prof., China Medical University, China

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: TCI Co., Ltd.
• ClinicalTrials.gov Identifier: NCT04692792
• Other Study ID Numbers: CMUH109-REC1-161
• First Posted: Jan 5, 2021
• Last Update Posted: Aug 4, 2021
• Last Verified: Aug 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by TCI Co., Ltd.: Obesity; Weight control; Dai Dai flower
• Additional relevant MeSH terms: Body Weight

Study Results

No Results Posted as of Aug 4, 2021