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Effect of Coadministration of Ume Paste (Prunus Mume) and Ginger Powder

Primary Purpose

Prediabetes

Status
Completed
Phase
Not Applicable
Locations
Japan
Study Type
Interventional
Intervention
Placebo
Ume paste and ginger powder
Sponsored by
Hiroshima University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Prediabetes

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Fasting plasma glucose 105-125 mg/dL

Exclusion Criteria:

  • Taking anti-diabetic drugs
  • Taking drugs or functional food that may affect blood glucose level
  • Pregnant or nursing a child
  • Participation in any clinical trial within 90 days of the commencement of the trial
  • Renal or hepatic dysfunction
  • Heart disease
  • History of severe disease and/or major surgery

Sites / Locations

  • Hiroshima University

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

Ume paste and ginger powder

Arm Description

3 placebo capsules/day for 12 weeks

3 experimental capsules/day for 12 weeks.

Outcomes

Primary Outcome Measures

Change in fasting plasma glucose from baseline
Change in 2h glucose concentration after the oral glucose tolerance test (OGTT) from baseline

Secondary Outcome Measures

Change in HbA1c from baseline
Change in glycoalbumin from baseline
Change in fasting insulin from baseline
Change in homeostasis model assessment-insulin resistance (HOMA-R) from baseline
HOMA-R is calculated as fasting insulin (mU/mL) x fasting glucose (mg/dL) / 405
Change in serum total cholesterol from baseline
Change in serum LDL cholesterol from baseline
Change in serum HDL cholesterol from baseline
Change in serum triglyceride from baseline

Full Information

First Posted
August 8, 2014
Last Updated
March 17, 2015
Sponsor
Hiroshima University
Collaborators
KAWAMOTO FOODS CO., LTD.
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1. Study Identification

Unique Protocol Identification Number
NCT02213549
Brief Title
Effect of Coadministration of Ume Paste (Prunus Mume) and Ginger Powder
Official Title
A Randomized, Double-blind, Placebo Controlled, Parallel Group Study to Determine the Effect of Ume Paste and Ginger Powder in Prediabetic Subjects.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
July 2014 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hiroshima University
Collaborators
KAWAMOTO FOODS CO., LTD.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This study is designed to evaluate the effect of ume paste and ginger powder on glucose metabolism in prediabetic subjects.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prediabetes

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
3 placebo capsules/day for 12 weeks
Arm Title
Ume paste and ginger powder
Arm Type
Experimental
Arm Description
3 experimental capsules/day for 12 weeks.
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Type
Dietary Supplement
Intervention Name(s)
Ume paste and ginger powder
Primary Outcome Measure Information:
Title
Change in fasting plasma glucose from baseline
Time Frame
Every 6 weeks (Overall 12 weeks)
Title
Change in 2h glucose concentration after the oral glucose tolerance test (OGTT) from baseline
Time Frame
Weeks 0 and 12
Secondary Outcome Measure Information:
Title
Change in HbA1c from baseline
Time Frame
Weeks 0 and 12
Title
Change in glycoalbumin from baseline
Time Frame
Weeks 0 and 12
Title
Change in fasting insulin from baseline
Time Frame
Weeks 0 and 12
Title
Change in homeostasis model assessment-insulin resistance (HOMA-R) from baseline
Description
HOMA-R is calculated as fasting insulin (mU/mL) x fasting glucose (mg/dL) / 405
Time Frame
Weeks 0 and 12
Title
Change in serum total cholesterol from baseline
Time Frame
Every 6 weeks (Overall 12 weeks)
Title
Change in serum LDL cholesterol from baseline
Time Frame
Every 6 weeks (Overall 12 weeks)
Title
Change in serum HDL cholesterol from baseline
Time Frame
Every 6 weeks (Overall 12 weeks)
Title
Change in serum triglyceride from baseline
Time Frame
Every 6 weeks (Overall 12 weeks)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Fasting plasma glucose 105-125 mg/dL Exclusion Criteria: Taking anti-diabetic drugs Taking drugs or functional food that may affect blood glucose level Pregnant or nursing a child Participation in any clinical trial within 90 days of the commencement of the trial Renal or hepatic dysfunction Heart disease History of severe disease and/or major surgery
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fumiko Higashikawa, PhD
Organizational Affiliation
Hiroshima University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hiroshima University
City
Hiroshima
ZIP/Postal Code
734-8551
Country
Japan

12. IPD Sharing Statement

Learn more about this trial

Effect of Coadministration of Ume Paste (Prunus Mume) and Ginger Powder

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