Anti-diabetic Effects of Persimmon Leaf Extract

Prediabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02706821
• Other study ID #: WJG-HG-PLE
• Status: Completed
• Phase: N/A
• First received: March 8, 2016
• Last updated: March 13, 2016
• Start date: February 2014
• Est. completion date: February 2015

Study information

• Verified date: March 2016
• Source: Chonbuk National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Ministry of Food and Drug Safety
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: February 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 75 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Glucose Intolerance
• Prediabetes
• Prediabetic State

Intervention

Dietary Supplement:
• Persimmon leaf extract
Persimmon leaf extract (PLE), crossover design
• Placebo
Placebo, crossover design

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Chonbuk National University Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fasting and postprandial plasma glucose		baseline day 57, 85 and 141	Yes
Secondary	Fasting plasma insulin		baseline and day 57, 85 and 141	Yes
Secondary	C-peptide		baseline and day 57, 85 and 141	Yes
Secondary	Glycated hemoglobin (HbA1c)		baseline and day 57, 85 and 141	Yes
Secondary	adiponectin		baseline and day 57, 85 and 141	Yes
Secondary	leptin		baseline and day 57, 85 and 141	Yes
Secondary	resistin		baseline and day 57, 85 and 141	Yes
Secondary	Markers of Inflammation		baseline and day 57, 85 and 141	Yes
Secondary	Tumor necrosis factor alpha (TNF-a)		baseline and day 57, 85 and 141	Yes
Secondary	Interleukin-6 (IL-6)		baseline and day 57, 85 and 141	Yes
Secondary	Monocyte chemoattractant protein-1 (MCP-1)		baseline and day 57, 85 and 141	Yes