PrediabetesNCT02706821
Anti-diabetic Effects of Persimmon Leaf Extract
A study testing Persimmon leaf extract in people with Prediabetes, run by Chonbuk National University Hospital.
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. Read more about this study
- Who is it for?
- Ages 20 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Prediabetes
- What is being tested?
- Persimmon leaf extract
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 34 participants
- Where
- No sites listed yet
- Study dates
- Feb 2014to Feb 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 20-75 years
- Fasting blood glucose (FPG) 100~140 mg/dL or postprandial blood glucose (PPG) 140~250 mg/dL
Who cannot join
- 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
About this study
Official title: An Eight-week, Randomized, Double-blind, Placebo-controlled Crossover Clinical Trial of Persimmon Leaf Extract on Anti-diabetes
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.
- Conditions
- Prediabetes
- Being tested
- Persimmon leaf extract, Placebo
- Keywords
- prediabetes, blood glucose, clinical trial
- Medical subject headings
- Prediabetic State
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Persimmon leaf extractDietary supplement
Persimmon leaf extract (PLE), crossover design
PlaceboDietary supplement
Placebo, crossover design
| Study group | Role | What they receive |
|---|---|---|
| Treatment sequence 1 | Active comparator | PLE (persimmon leaf extract) once a day during 8 weeks cross-over to placebo once a day during 8 weeks. Receives: Dietary Supplement: Persimmon leaf extract; Dietary Supplement: Placebo |
| Treatment sequence 2 | Active comparator | Placebo once a day during 8 weeks cross-over to PLE once a day during 8 weeks. Receives: Dietary Supplement: Persimmon leaf extract; Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fasting and postprandial plasma glucose
Measured: baseline day 57, 85 and 141
Secondary outcomes (10)
Fasting plasma insulin
Measured: baseline and day 57, 85 and 141
C-peptide
Measured: baseline and day 57, 85 and 141
Glycated hemoglobin (HbA1c)
Measured: baseline and day 57, 85 and 141
adiponectin
Measured: baseline and day 57, 85 and 141
leptin
Measured: baseline and day 57, 85 and 141
resistin
Measured: baseline and day 57, 85 and 141
Markers of Inflammation
Measured: baseline and day 57, 85 and 141
Tumor necrosis factor alpha (TNF-α)
Measured: baseline and day 57, 85 and 141
Interleukin-6 (IL-6)
Measured: baseline and day 57, 85 and 141
Monocyte chemoattractant protein-1 (MCP-1)
Measured: baseline and day 57, 85 and 141
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2016 (estimated)
- Study startFeb 2014
- Primary completionDec 2014
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PrediabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chonbuk National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Soo-Wan Chae, Chonbuk National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02706821
- Sponsor's protocol ID
- WJG-HG-PLE
- Status last verified
- Mar 2016
- First submitted
- 8 Mar 2016
- Last updated
- 15 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Eight-week, Randomized, Double-blind, Placebo-controlled Crossover Clinical Trial of Persimmon Leaf Extract on Anti-diabetes
- ClinicalTrials.gov ID
- NCT02706821
- Acronym / sponsor ID
- WJG-HG-PLE
- Conditions
- Prediabetes
- Keywords
- prediabetes, blood glucose, clinical trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Chonbuk National University HospitalUniversity, hospital or other
- Study start
- Feb 2014
- Primary completion
- Dec 2014 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 11 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment sequence 1 | Active comparator | Dietary Supplement: Persimmon leaf extract, Dietary Supplement: PlaceboPLE (persimmon leaf extract) once a day during 8 weeks cross-over to placebo once a day during 8 weeks. |
| Treatment sequence 2 | Active comparator | Dietary Supplement: Persimmon leaf extract, Dietary Supplement: PlaceboPlacebo once a day during 8 weeks cross-over to PLE once a day during 8 weeks. |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age 20-75 years
- Fasting blood glucose (FPG) 100~140 mg/dL or postprandial blood glucose (PPG) 140~250 mg/dL
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Persimmon leaf extractPersimmon leaf extract (PLE), crossover design | Dietary supplement | Treatment sequence 1, Treatment sequence 2 |
| PlaceboPlacebo, crossover design | Dietary supplement | Treatment sequence 1, Treatment sequence 2 |
Primary outcome
Fasting and postprandial plasma glucose
Time frame: baseline day 57, 85 and 141
10 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Persimmon leaf extract in people with Prediabetes, run by Chonbuk National University Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fasting and postprandial plasma glucose (time frame: baseline day 57, 85 and 141). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2016; AzTrials last refreshed its copy on 6 Nov 2026.