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

Not Applicable

Completed

• Conditions: Prediabetes

• Registration Number: NCT02213549
• Lead Sponsor: Hiroshima University

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2014-07
• Study First Submitted: 2014-08-08
• Study First Submitted QC: 2014-08-08
• Study First Posted: 2014-08-11
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-17
• Last Update Posted: 2015-03-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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	HOMA-R is calculated as fasting insulin (mU/mL) x fasting glucose (mg/dL) / 405
Change in serum total cholesterol from baseline	Every 6 weeks (Overall 12 weeks)
Change in serum LDL cholesterol from baseline	Every 6 weeks (Overall 12 weeks)
Change in serum HDL cholesterol from baseline	Every 6 weeks (Overall 12 weeks)
Change in serum triglyceride from baseline	Every 6 weeks (Overall 12 weeks)

Trial Locations

Locations (1)

Hiroshima University; 🇯🇵 Hiroshima, Japan