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

Amorepacific

Status: Enrolling

Conditions: Body Fat

Treatments: Dietary Supplement: Placebo; Dietary Supplement: HTGT compound

Study type: Interventional

Funder types: Industry

Identifiers

NCT06609603

AP-PV-2023-01

Details and patient eligibility

About

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

Full description

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 19 to 64 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups, including a placebo group

HTGT compound

Experimental group

Description:

* Dietary supplement: HTGT compound * oral administration of HTGT compound once daily, 2 capsules per day. * Dietary supplement; Placebo * oral administration of placebo once daily, 2 canpules per day

Treatment:

Dietary Supplement: HTGT compound

Placebo

Placebo Comparator group

Description:

Once daily, 2 capsules per day

Treatment:

Dietary Supplement: Placebo