NCT04850326

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 24, 2020

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 2, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 26, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 14, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 20, 2021

Completed
Last Updated

June 16, 2021

Status Verified

June 1, 2021

Enrollment Period

5 months

First QC Date

April 14, 2021

Last Update Submit

June 15, 2021

Conditions

Blood Glucose, High

Outcome Measures

Primary Outcomes (3)

  • 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

Study Arms (2)

AP green tea extract

EXPERIMENTAL
Dietary Supplement: AP green tea extract

No intervention control

NO INTERVENTION

Interventions

AP green tea extractDIETARY_SUPPLEMENT

single intake of AP green tea extract

AP green tea extract

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

KangBuk Samsung Medical Center

Seoul, 03181, South Korea

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 14, 2021

First Posted

April 20, 2021

Study Start

July 24, 2020

Primary Completion

January 2, 2021

Study Completion

February 26, 2021

Last Updated

June 16, 2021

Record last verified: 2021-06

Locations

KR(1)