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NCT Number: NCT06609603

Clinical Study to Evaluate the Body Fat Reducing Effects of Heat-Treated Green Tea Extract Complex

This clinical study was designed to evaluate the efficacy and safety of body fat reduction in obese adults by treatment of heat-treated green tea extract complex

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Key information

Conditions

Age range

19 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Catholic University St. Vincent Hospital

Suwon, Gyeonggi-do, South Korea

Location status: Recruiting

Location contact

Sang-Wook Song, M.D./Ph.D.

CONTACT

[email protected]

82-31-881-8859

About this study

This study is a 12-week, randomized, double-blind, placebo-controlled clinical trial. 100 subjects were ranromly assigned to heat-treated green tea extract(HTGT) group and placebo group. The changes in the efficacy endpoint were evaluated after treatment of 2 capsules of HTGT once daiy for 12 weeks.

Who can participate

Healthy volunteers accepted: Yes

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

  • lt;Inclusion Criteria>
  • Males and females aged between 19 ~ 64 years
  • BMI 25.0 ~ 34.9 kg/m^2
  • Waist circumferebce: 90cm or more for men, 85cm or more for women
  • Subjects who have fully understand the information provided about the study and voluntarily decided to participate
  • lt;Exclusion Criteria>
  • Participants whose weight changed by more than 10% within the 3 months prior to visit 1
  • Individuals participated in a commercial weight loss program within 3 months prior to Visit 1
  • Participants who have undergone surgical procedures within 3 years
  • Participants who have taken obesity treatment medications within the last 3 months
  • Individuals who have taken medications affecting weight or dietary supplements for weight control within the last month
  • Subjects with uncontrolled hypertension
  • Subjects diagnosed with diabetes
  • TSH <0.1 uIU/ml or >10 uIU/ml
  • Creatinine >1.5mg/dL
  • AST or ALT > three times the upper normal limit

Treatment and study plan

HTGT compound

Dietary Supplement

oral administration of HTGT compound once daily

Placebo

Dietary Supplement

Oral administration of placebo once daily

Primary outcomes

  1. Change of body fat by DEXA

    Time frame: Baseline, Week 12

    Measurement was made by using dual-energy X-ray absorption(DEXA)

Secondary outcomes

  1. Changes of total abdominal fat area, visceral fat area and subcutaneous fat area

    Time frame: Baseline, Week 12

    Measurement of the target area is made using computed tomography

  2. Changes of indicator of lipid metabolism

    Time frame: Baseline, Week 12

    indicator of lipid metabolism (i.e., TC, TG, HDL, LDL)

  3. Changes of waist circumference

    Time frame: Baseline, Week 12

    Measurement of waist circumfernece was performed in accordance with WHO guideline

  4. Changes of blood biomarker

    Time frame: Baseline, Week 12

    adiponectin, etc.

Study contacts

Contact information is provided by the study sponsor or research team.

HyunJin Nam, Ph.D.

CONTACT

Jonghee Sohn

CONTACT

[email protected]

800-555-5555

Sponsors and collaborators

Lead sponsor

Amorepacific Corporation

Industry

Registry information

Official study title

A Randomized, Double-blind, Placebo-controlled, Parallel-design Clinical Study to Evaluate the Body Fat Reducing Effect of Heat-Treated Green Tea Extract Complex

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Sep 24, 2024
Registry last updated
Sep 24, 2024

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.

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