NCT02213549

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2014

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

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

July 1, 2014

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 8, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 11, 2014

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

March 19, 2015

Status Verified

March 1, 2015

Enrollment Period

5 months

First QC Date

August 8, 2014

Last Update Submit

March 17, 2015

Conditions

Prediabetes

Outcome Measures

Primary Outcomes (2)

  • Change in fasting plasma glucose from baseline

    Every 6 weeks (Overall 12 weeks)

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

    Weeks 0 and 12

Secondary Outcomes (8)

  • Change in HbA1c from baseline

    Weeks 0 and 12

  • Change in glycoalbumin from baseline

    Weeks 0 and 12

  • Change in fasting insulin from baseline

    Weeks 0 and 12

  • Change in homeostasis model assessment-insulin resistance (HOMA-R) from baseline

    Weeks 0 and 12

  • Change in serum total cholesterol from baseline

    Every 6 weeks (Overall 12 weeks)

  • +3 more secondary outcomes

Study Arms (2)

Placebo

PLACEBO COMPARATOR

3 placebo capsules/day for 12 weeks

Dietary Supplement: Placebo

Ume paste and ginger powder

EXPERIMENTAL

3 experimental capsules/day for 12 weeks.

Dietary Supplement: Ume paste and ginger powder

Interventions

PlaceboDIETARY_SUPPLEMENT
Placebo
Ume paste and ginger powderDIETARY_SUPPLEMENT
Ume paste and ginger powder

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Fasting plasma glucose 105-125 mg/dL

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hiroshima University

Hiroshima, 734-8551, Japan

Location

MeSH Terms

Conditions

Prediabetic State

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Fumiko Higashikawa, PhD

    Hiroshima University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

August 8, 2014

First Posted

August 11, 2014

Study Start

July 1, 2014

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

March 19, 2015

Record last verified: 2015-03

Locations

JP(1)