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Completed

NCT Number: NCT04850326

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

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.

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Key information

Conditions

Blood Glucose, High

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

KangBuk Samsung Medical Center

Seoul, 03181, South Korea

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

AP green tea extract

Dietary Supplement

single intake of AP green tea extract

Primary outcomes

  1. Change of Blood glucose level

    Time frame: 0 - 300 minute

    Change of Blood glucose level before and after high-carbohydrate/high-fat meal

  2. Change of Insulin level

    Time frame: 0 - 300 minute

    Change of Insulin level before and after high-carbohydrate/high-fat meal

  3. Change of Triglyceride level

    Time frame: 0 - 300 minute

    Change of Triglyceride level before and after high-carbohydrate/high-fat meal

Sponsors and collaborators

Lead sponsor

Amorepacific Corporation

Industry

Registry information

Official study title

A Randomized, Cross-Over Clinical Study to Evaluate the Acute Efficacy of AP Green Tea Extract After a Meal Composed of High-Fat/High-Carbohydrate

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Apr 20, 2021
Registry last updated
Jun 16, 2021

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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