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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02213549
Other study ID # eki-996
Secondary ID
Status Completed
Phase N/A
First received August 8, 2014
Last updated March 17, 2015
Start date July 2014
Est. completion date December 2014

Study information

Verified date March 2015
Source Hiroshima University
Contact n/a
Is FDA regulated No
Health authority Japan: Institutional Review Board
Study type Interventional

Clinical Trial Summary

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


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date December 2014
Est. primary completion date December 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 20 Years to 70 Years
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Placebo

Ume paste and ginger powder


Locations

Country Name City State
Japan Hiroshima University Hiroshima

Sponsors (2)

Lead Sponsor Collaborator
Hiroshima University KAWAMOTO FOODS CO., LTD.

Country where clinical trial is conducted

Japan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in fasting plasma glucose from baseline Every 6 weeks (Overall 12 weeks) No
Primary Change in 2h glucose concentration after the oral glucose tolerance test (OGTT) from baseline Weeks 0 and 12 No
Secondary Change in HbA1c from baseline Weeks 0 and 12 No
Secondary Change in glycoalbumin from baseline Weeks 0 and 12 No
Secondary Change in fasting insulin from baseline Weeks 0 and 12 No
Secondary 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 Weeks 0 and 12 No
Secondary Change in serum total cholesterol from baseline Every 6 weeks (Overall 12 weeks) No
Secondary Change in serum LDL cholesterol from baseline Every 6 weeks (Overall 12 weeks) No
Secondary Change in serum HDL cholesterol from baseline Every 6 weeks (Overall 12 weeks) No
Secondary Change in serum triglyceride from baseline Every 6 weeks (Overall 12 weeks) No
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