Clinical Study to Evaluate the Short Time Efficacy of AP... | NCT04850326

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

NCT04850326

Sponsor

Amorepacific Corporation

Status

Completed

Last Update Posted

Jun 16, 2021Actual

Enrollment

20Actual

Phase

Not Applicable

Conditions

Blood Glucose, High

Interventions

AP green tea extract

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 24, 2020Actual

Primary Completion Date

Jan 2, 2021Actual

Completion Date

Feb 26, 2021Actual

First Submitted Date

Apr 14, 2021

First Submission Date that Met QC Criteria

Apr 19, 2021

First Posted Date

Apr 20, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 15, 2021

Last Update Posted Date

Jun 16, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
AP green tea extract	Experimental		Dietary Supplement: AP green tea extract
No intervention control	No Intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
AP green tea extract	Dietary Supplement	single intake of AP green tea extract	AP green tea extract

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change of Blood glucose level	Change of Blood glucose level before and after high-carbohydrate/high-fat meal	0 - 300 minute
Change of Insulin level	Change of Insulin level before and after high-carbohydrate/high-fat meal	0 - 300 minute
Change of Triglyceride level	Change of Triglyceride level before and after high-carbohydrate/high-fat meal	0 - 300 minute

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided