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

ConditionBody Fat
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age19-64
SponsorAmorepacific Corporation

About this trial

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

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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Males and females aged between 19 ~ 64 years

BMI 25.0 ~ 34.9 kg/m²

Waist circumferebce: 90cm or more for men, 85cm or more for women

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • HTGT compound

    Dietary supplement

    oral administration of HTGT compound once daily

  • Placebo

    Dietary supplement

    Oral administration of placebo once daily

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: HTGT compoundExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change of body fat by DEXA

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

Time frame
Baseline, Week 12

Secondary outcomes

1

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

Measurement of the target area is made using computed tomography

Time frame
Baseline, Week 12
2

Changes of indicator of lipid metabolism

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

Time frame
Baseline, Week 12
3

Changes of waist circumference

Measurement of waist circumfernece was performed in accordance with WHO guideline

Time frame
Baseline, Week 12
4

Changes of blood biomarker

adiponectin, etc.

Time frame
Baseline, Week 12

Other outcomes

Sponsors and contacts

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