Anti-diabetic Effects of Persimmon Leaf Extract

Overview

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.

Full Title of Study: “An Eight-week, Randomized, Double-blind, Placebo-controlled Crossover Clinical Trial of Persimmon Leaf Extract on Anti-diabetes”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Prevention
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: December 2014

Interventions

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

Arms, Groups and Cohorts

  • Active Comparator: Treatment sequence 1
    • PLE (persimmon leaf extract) once a day during 8 weeks cross-over to placebo once a day during 8 weeks.
  • Active Comparator: Treatment sequence 2
    • Placebo once a day during 8 weeks cross-over to PLE once a day during 8 weeks.

Clinical Trial Outcome Measures

Primary Measures

  • Fasting and postprandial plasma glucose
    • Time Frame: baseline day 57, 85 and 141

Secondary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 20 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Chonbuk National University Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: Soo-Wan Chae, Professor – Chonbuk National University Hospital

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