Anti-diabetic Effects of Persimmon Leaf Extract

Study Overview
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Brief Summary
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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.

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

Conditions
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Prediabetes

Intervention / Treatment
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* Dietary Supplement: Persimmon leaf extract
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Treatment sequence 1<br>PLE (persimmon leaf extract) once a day during 8 weeks cross-over to placebo once a day during 8 weeks. | Dietary Supplement: Persimmon leaf extract<br>* Persimmon leaf extract (PLE), crossover design<br>Dietary Supplement: Placebo<br>* Placebo, crossover design<br>|
| Active Comparator: Treatment sequence 2<br>Placebo once a day during 8 weeks cross-over to PLE once a day during 8 weeks. | Dietary Supplement: Persimmon leaf extract<br>* Persimmon leaf extract (PLE), crossover design<br>Dietary Supplement: Placebo<br>* Placebo, crossover design<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fasting and postprandial plasma glucose |  | baseline day 57, 85 and 141 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fasting plasma insulin |  | baseline and day 57, 85 and 141 | 
| C-peptide |  | 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 | 
| resistin |  | baseline and day 57, 85 and 141 | 
| Markers of Inflammation |  | baseline and day 57, 85 and 141 | 
| Tumor necrosis factor alpha (TNF-α) |  | baseline and day 57, 85 and 141 | 
| Interleukin-6 (IL-6) |  | baseline and day 57, 85 and 141 | 
| Monocyte chemoattractant protein-1 (MCP-1) |  | baseline and day 57, 85 and 141 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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prediabetes, blood glucose, clinical trial