Anti-diabetic Effects of Persimmon Leaf Extract

Not Applicable

Completed

• Conditions: Prediabetes
• Interventions: Dietary Supplement: Persimmon leaf extract; Dietary Supplement: Placebo

• Registration Number: NCT02706821
• Lead Sponsor: Chonbuk National University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-02
• Primary Completion: 2014-12
• Study Completion: 2015-02
• Status Verified: 2016-03
• Study First Submitted: 2016-03-08
• Study First Submitted QC: 2016-03-08
• Study First Posted: 2016-03-11
• Last Update Submitted: 2016-03-13
• Last Update Posted: 2016-03-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Treatment sequence 1	Placebo	PLE (persimmon leaf extract) once a day during 8 weeks cross-over to placebo once a day during 8 weeks.
Treatment sequence 2	Persimmon leaf extract	Placebo once a day during 8 weeks cross-over to PLE once a day during 8 weeks.
Treatment sequence 2	Placebo	Placebo once a day during 8 weeks cross-over to PLE once a day during 8 weeks.
Treatment sequence 1	Persimmon leaf extract	PLE (persimmon leaf extract) once a day during 8 weeks cross-over to placebo once a day during 8 weeks.

Primary Outcome Measures

Name	Time	Method
Fasting and postprandial plasma glucose	baseline day 57, 85 and 141

Secondary Outcome Measures

Name	Time	Method
resistin	baseline and day 57, 85 and 141
Interleukin-6 (IL-6)	baseline and day 57, 85 and 141
Glycated hemoglobin (HbA1c)	baseline and day 57, 85 and 141
adiponectin	baseline and day 57, 85 and 141
leptin	baseline and day 57, 85 and 141
Fasting plasma insulin	baseline and day 57, 85 and 141
Tumor necrosis factor alpha (TNF-α)	baseline and day 57, 85 and 141
Monocyte chemoattractant protein-1 (MCP-1)	baseline and day 57, 85 and 141
C-peptide	baseline and day 57, 85 and 141
Markers of Inflammation	baseline and day 57, 85 and 141