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

March 17, 2015 updated by: Fumiko Higashikawa, Hiroshima University

A Randomized, Double-blind, Placebo Controlled, Parallel Group Study to Determine the Effect of Ume Paste and Ginger Powder in Prediabetic Subjects.

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Hiroshima, Japan, 734-8551
        • Hiroshima University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
3 placebo capsules/day for 12 weeks
Dietary supplement: Placebo
Experimental: Ume paste and ginger powder
3 experimental capsules/day for 12 weeks.
Dietary supplement: Ume paste and ginger powder

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in fasting plasma glucose from baseline
Time Frame: Every 6 weeks (Overall 12 weeks)
Every 6 weeks (Overall 12 weeks)
Change in 2h glucose concentration after the oral glucose tolerance test (OGTT) from baseline
Time Frame: Weeks 0 and 12
Weeks 0 and 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in HbA1c from baseline
Time Frame: Weeks 0 and 12
Weeks 0 and 12
Change in glycoalbumin from baseline
Time Frame: Weeks 0 and 12
Weeks 0 and 12
Change in fasting insulin from baseline
Time Frame: Weeks 0 and 12
Weeks 0 and 12
Change in homeostasis model assessment-insulin resistance (HOMA-R) from baseline
Time Frame: Weeks 0 and 12
HOMA-R is calculated as fasting insulin (mU/mL) x fasting glucose (mg/dL) / 405
Weeks 0 and 12
Change in serum total cholesterol from baseline
Time Frame: Every 6 weeks (Overall 12 weeks)
Every 6 weeks (Overall 12 weeks)
Change in serum LDL cholesterol from baseline
Time Frame: Every 6 weeks (Overall 12 weeks)
Every 6 weeks (Overall 12 weeks)
Change in serum HDL cholesterol from baseline
Time Frame: Every 6 weeks (Overall 12 weeks)
Every 6 weeks (Overall 12 weeks)
Change in serum triglyceride from baseline
Time Frame: Every 6 weeks (Overall 12 weeks)
Every 6 weeks (Overall 12 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hiroshima University

Collaborators

KAWAMOTO FOODS CO., LTD.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2014

Primary Completion (Actual)

December 1, 2014

Study Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

August 8, 2014

First Submitted That Met QC Criteria

August 8, 2014

First Posted (Estimate)

August 11, 2014

Study Record Updates

Last Update Posted (Estimate)

March 19, 2015

Last Update Submitted That Met QC Criteria

March 17, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • eki-996

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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