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Clinical Study to Evaluate the Short Time Efficacy of AP Green Tea Extract Affer High Fat, High Carbohydrate Diet

A

Amorepacific

Status

Completed

Conditions

Blood Glucose, High

Treatments

Dietary Supplement: AP green tea extract

Study type

Interventional

Funder types

Industry

Identifiers

NCT04850326
AP-R-2019-02

Details and patient eligibility

About

The objective of this clinical trial is to evaluate the short term effects of single dose AP green tea extracts in subjects with BMI (< 30 kg/m2) and fasting glucose level of > 100 mg/dL after high-fat/high-carbohydrate meal.

Enrollment

20 patients

Sex

All

Ages

19+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Subjects aged 19 years or over
  • BMI < 30 kg/m2
  • Fasting glucose level > 100 mg/dL (who is not under medication)
  • Subjects who voluntarily decide to participate in this clinical study and sign the informed consent form on their own or through their representatives

Exclusion criteria

  • At the screening visit, subjects who were diagnosed with obesity, diabetes, dyslipidemia and undergoing medication
  • Subjects who were diagnosed with ventricular associated disease, unstable and uncontrolled chronic medical disease, hyper/hypothyroidism, or active malignant tumor and undergoing medication within 4 weeks prior to the first administration of the investigational product
  • Subjects who have renal failure, acute or chronic hepatitis or known liver cirrhosis
  • In addition to the above, subjects who are determined to be ineligible to participate in the clinical study according to the investigator's medical opinion

Trial design

Primary purpose

Supportive Care

Allocation

Non-Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

20 participants in 2 patient groups

AP green tea extract
Experimental group
Treatment:
Dietary Supplement: AP green tea extract
No intervention control
No Intervention group

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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