Anti-diabetic Effects of Persimmon Leaf Extract

NCT ID: NCT02706821

Last Updated: 2016-03-15

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

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-02-28

Study Completion Date

2015-02-28

Brief Summary

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The investigators performed a 8-week, randomized, double-blind, placebo-controlled crossover human trial to evaluate the efficacy and safety of persimmon leaf extract on blood glucose. The investigators measures changes in diabetes associated parameters, including fasting blood glucose, postprandial blood glucose, insulin, C-peptide and HbA1c.

Detailed Description

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Conditions

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Prediabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Treatment sequence 1

PLE (persimmon leaf extract) once a day during 8 weeks cross-over to placebo once a day during 8 weeks.

Group Type ACTIVE_COMPARATOR

Persimmon leaf extract

Intervention Type DIETARY_SUPPLEMENT

Persimmon leaf extract (PLE), crossover design

Placebo

Intervention Type DIETARY_SUPPLEMENT

Placebo, crossover design

Treatment sequence 2

Placebo once a day during 8 weeks cross-over to PLE once a day during 8 weeks.

Group Type ACTIVE_COMPARATOR

Persimmon leaf extract

Intervention Type DIETARY_SUPPLEMENT

Persimmon leaf extract (PLE), crossover design

Placebo

Intervention Type DIETARY_SUPPLEMENT

Placebo, crossover design

Interventions

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Persimmon leaf extract

Persimmon leaf extract (PLE), crossover design

Intervention Type DIETARY_SUPPLEMENT

Placebo

Placebo, crossover design

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* Age 20-75 years
* Fasting blood glucose (FPG) 100\~140 mg/dL or postprandial blood glucose (PPG) 140\~250 mg/dL

Exclusion Criteria

* FPG more than 140 mg/dL
* 2h PPG more than 200 mg/dL
* Type 1 diabetes or HbA1c more than 9.0%
* treatment with corticosteroids within the past 4 weeks
* cardiovascular disease
Minimum Eligible Age

20 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Chonbuk National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Soo-Wan Chae

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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WJG-HG-PLE

Identifier Type: -

Identifier Source: org_study_id

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