Clinical Study to Evaluate the Effects and Safety of Green Tea Extract on Blood Glucose Regulation

ConditionBlood Sugar
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age19-64
SponsorAmorepacific Corporation

About this trial

This study was conducted to investigate the effects of green tea extracts on reducing blood glucose level

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Males and females aged between 19 to 64 years

BMI between 18.5 and 29.9kg/m²

fasting blood glucose between 100 and 139 mg/dL (Note: if some subjects with blood glucose range of 126 - 139 mg/dL, those who are taking or requre medication must be excluded to meet ethical standards.)

subjects who voluntarily decide to participate in this study and sign the informed consent form.

Disqualifiers

Individuals taking to obesity, dyslipidemia, or uncontrolled hypertension at the screening

Individuals diagnosed with diabetes and who have taken medications related to blood glucose

Individuals congenital enzyme deficiencies related to sugar metabolism.

with hypersensitivity to the test food or ingredients(e.g., green tea, caffeine).

Trial design

Design model

Parallel

Treatments tested in this trial

  • GTE

    Dietary supplement

    oral administration of GTE tablets once daily for 12 weeks

  • Placebo

    Dietary supplement

    oral administration of placebo tablets once daily for 12 weeks

Treatment groups

84 Participants
are divided into 2 treatment groups
Group A: GTE (Green tea extract)Active comparator 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change in fasting glucose level

blood glucose level detection

Time frame
Baseline, week 12

Secondary outcomes

1

changes of indicator of lipid metabolism

Total cholesterol, HDL, LDL, TG

Time frame
Baseline, week 12
2

OGTT

oral glucose tolerance test

Time frame
Baseline, week 12
3

blood biomarkers

insulin etc.

Time frame
Baseline, week 12
4

change in waist circumference(cm)

-waist circumference was measured using WHO guideline

Time frame
Baseline, week 12

Other outcomes

Sponsors and contacts

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