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

NCT ID: NCT04850326

Last Updated: 2021-06-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-24

Study Completion Date

2021-02-26

Brief Summary

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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.

Detailed Description

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Conditions

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Blood Glucose, High

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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AP green tea extract

Group Type EXPERIMENTAL

AP green tea extract

Intervention Type DIETARY_SUPPLEMENT

single intake of AP green tea extract

No intervention control

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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AP green tea extract

single intake of AP green tea extract

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Amorepacific Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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KangBuk Samsung Medical Center

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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AP-R-2019-02

Identifier Type: -

Identifier Source: org_study_id

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