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OpenTrials
Completed

NCT Number: NCT02706821

Anti-diabetic Effects of Persimmon Leaf Extract

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.

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Key information

Conditions

PreDiabetes Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Prediabetic State

Age range

20 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Persimmon leaf extract

Dietary Supplement

Persimmon leaf extract (PLE), crossover design

Placebo

Dietary Supplement

Placebo, crossover design

Primary outcomes

  1. Fasting and postprandial plasma glucose

    Time frame: baseline day 57, 85 and 141

Secondary outcomes

  1. Fasting plasma insulin

    Time frame: baseline and day 57, 85 and 141

  2. C-peptide

    Time frame: baseline and day 57, 85 and 141

  3. Glycated hemoglobin (HbA1c)

    Time frame: baseline and day 57, 85 and 141

  4. adiponectin

    Time frame: baseline and day 57, 85 and 141

  5. leptin

    Time frame: baseline and day 57, 85 and 141

  6. resistin

    Time frame: baseline and day 57, 85 and 141

  7. Markers of Inflammation

    Time frame: baseline and day 57, 85 and 141

  8. Tumor necrosis factor alpha (TNF-α)

    Time frame: baseline and day 57, 85 and 141

  9. Interleukin-6 (IL-6)

    Time frame: baseline and day 57, 85 and 141

  10. Monocyte chemoattractant protein-1 (MCP-1)

    Time frame: baseline and day 57, 85 and 141

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Sponsors and collaborators

Lead sponsor

Chonbuk National University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2014
Study completion
2015
First posted
Mar 11, 2016
Registry last updated
Mar 15, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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