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

Prediabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02213549
• Other study ID #: eki-996
• 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

• Prediabetes

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