NCT02706821

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2014

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2014

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2015

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

March 8, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 11, 2016

Completed
Last Updated

March 15, 2016

Status Verified

March 1, 2016

Enrollment Period

10 months

First QC Date

March 8, 2016

Last Update Submit

March 13, 2016

Conditions

Prediabetes

Keywords

prediabetesblood glucoseclinical trial

Outcome Measures

Primary Outcomes (1)

  • Fasting and postprandial plasma glucose

    baseline day 57, 85 and 141

Secondary Outcomes (10)

  • 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

  • +5 more secondary outcomes

Study Arms (2)

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.

Dietary Supplement: Persimmon leaf extractDietary Supplement: Placebo

Treatment sequence 2

ACTIVE COMPARATOR

Placebo once a day during 8 weeks cross-over to PLE once a day during 8 weeks.

Dietary Supplement: Persimmon leaf extractDietary Supplement: Placebo

Interventions

Persimmon leaf extractDIETARY_SUPPLEMENT

Persimmon leaf extract (PLE), crossover design

Treatment sequence 1Treatment sequence 2
PlaceboDIETARY_SUPPLEMENT

Placebo, crossover design

Treatment sequence 1Treatment sequence 2

Eligibility Criteria

Age20 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 20-75 years
  • Fasting blood glucose (FPG) 100\~140 mg/dL or postprandial blood glucose (PPG) 140\~250 mg/dL

You may not qualify if:

  • FPG more than 140 mg/dL
  • h 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Prediabetic State

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 8, 2016

First Posted

March 11, 2016

Study Start

February 1, 2014

Primary Completion

December 1, 2014

Study Completion

February 1, 2015

Last Updated

March 15, 2016

Record last verified: 2016-03