Skip to main content
OpenTrials
Completed

NCT Number: NCT04692792

Efficacy Evaluation of Dai Dai Flower on Body Weight

To assess the Dai Dai flower extract on body weight control

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Gastroenterology Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

China Medical University

Taichung, 404, Taiwan

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Placebo drink

Dietary Supplement

consume 1 bottle (50 mL) per day for 8 weeks

Dai Dai flower drink

Dietary Supplement

consume 1 bottle (50 mL) per day for 8 weeks

Primary outcomes

  1. The change of body weight

    Time frame: Change from Baseline body weight at 8 weeks

    The body weight (kg) was assessed by InBody.

  2. The change of BMI

    Time frame: Change from Baseline BMI at 8 weeks

    The BMI was assessed by InBody.

Secondary outcomes

  1. The change of body fat mass

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: Change from Baseline basal metabolic rate at 8 weeks

    The basal metabolic rate was assessed by InBody.

  5. The change of AST

    Time frame: Change from Baseline AST at 8 weeks

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

  6. The change of ALT

    Time frame: Change from Baseline ALT at 8 weeks

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

  7. The change of Creatinine

    Time frame: Change from Baseline creatinine at 8 weeks

    Venous blood was sampled to measure concentrations of creatinine

  8. The change of BUN

    Time frame: 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

    Time frame: Change from Baseline fasting glycemia at 8 weeks

    Venous blood was sampled to measure concentrations of fasting glycemia

  10. The change of total cholesterol

    Time frame: Change from Baseline total cholesterol at 8 weeks

    Venous blood was sampled to measure concentrations of total cholesterol

  11. The change of triglyceride

    Time frame: Change from Baseline triglyceride at 8 weeks

    Venous blood was sampled to measure concentrations of triglyceride

  12. The change of HDL-cholesterol

    Time frame: Change from Baseline HDL-cholesterol at 8 weeks

    Venous blood was sampled to measure concentrations of HDL-cholesterol

  13. The change of LDL-cholesterol

    Time frame: Change from Baseline LDL-cholesterol at 8 weeks

    Venous blood was sampled to measure concentrations of LDL-cholesterol

  14. The change of insulin

    Time frame: Change from Baseline insulin at 8 weeks

    Venous blood was sampled to measure concentrations of insulin

  15. The change of adiponectin

    Time frame: Change from Baseline adiponectin at 8 weeks

    Venous blood was sampled to measure concentrations of adiponectin

  16. The change of leptin

    Time frame: Change from Baseline leptin at 8 weeks

    Venous blood was sampled to measure concentrations of leptin

  17. The change of IFN-γ

    Time frame: Change from Baseline IFN-γ at 8 weeks

    Venous blood was sampled to measure concentrations of IFN-γ

  18. The change of IL-2

    Time frame: Change from Baseline IL-2 at 8 weeks

    Venous blood was sampled to measure concentrations of IL-2

  19. The change of IL-1beta

    Time frame: Change from Baseline IL-1beta at 8 weeks

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

Sponsors and collaborators

Lead sponsor

TCI Co., Ltd.

Industry

Registry information

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Jan 5, 2021
Registry last updated
Aug 4, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.