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Anti-diabetic Effects of Persimmon Leaf Extract

Primary Purpose

Prediabetes

Status

Completed

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Persimmon leaf extract

Placebo

About this trial

This is an interventional prevention trial for Prediabetes focused on measuring prediabetes, blood glucose, clinical trial

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Treatment sequence 1

Treatment sequence 2

Arm Description

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

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

Outcomes

Primary Outcome Measures

Fasting and postprandial plasma glucose

Secondary Outcome Measures

Fasting plasma insulin

C-peptide

Glycated hemoglobin (HbA1c)

adiponectin

leptin

resistin

Markers of Inflammation

Tumor necrosis factor alpha (TNF-α)

Interleukin-6 (IL-6)

Monocyte chemoattractant protein-1 (MCP-1)

Full Information

NCT ID

NCT02706821

First Posted

March 8, 2016

Last Updated

March 13, 2016

Sponsor

Chonbuk National University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT02706821

Brief Title

Anti-diabetic Effects of Persimmon Leaf Extract

Official Title

An Eight-week, Randomized, Double-blind, Placebo-controlled Crossover Clinical Trial of Persimmon Leaf Extract on Anti-diabetes

Study Type

Interventional

2. Study Status

Record Verification Date

March 2016

Overall Recruitment Status

Completed

Study Start Date

February 2014 (undefined)

Primary Completion Date

December 2014 (Actual)

Study Completion Date

February 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Chonbuk National University Hospital

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Prediabetes

Keywords

prediabetes, blood glucose, clinical trial

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

34 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Treatment sequence 1

Arm Type

Active Comparator

Arm Description

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

Arm Title

Treatment sequence 2

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Dietary Supplement

Intervention Name(s)

Persimmon leaf extract

Intervention Description

Persimmon leaf extract (PLE), crossover design

Intervention Type

Dietary Supplement

Intervention Name(s)

Placebo

Intervention Description

Placebo, crossover design

Primary Outcome Measure Information:

Title

Fasting and postprandial plasma glucose

Time Frame

baseline day 57, 85 and 141

Secondary Outcome Measure Information:

Title

Fasting plasma insulin

Time Frame