Effects of Blueberry Dry Powder on Glycemic Status in Subjects With Prediabetes

Prediabetes Clinical Trial

Official title:

A Randomized, Double-blind, Parallel Group Study to Evaluate the Effect of Blueberry Dry Powder on Prediabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02023320
• Other study ID #: eki-842
• Status: Completed
• Phase: N/A
• First received: December 17, 2013
• Last updated: August 7, 2014
• Start date: November 2013
• Est. completion date: July 2014

Study information

• Verified date: August 2014
• Source: Hiroshima University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The purpose of the present study is to evaluate the effect of blueberry dry powder on glycemic status (fasting plasma glucose, 2h glucose concentration after the oral glucose tolerance test (OGTT), or HbA1c) in subjects with prediabetes.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 70 Years

Eligibility

Inclusion Criteria:

• Fasting plasma glucose 110-125 mg/dL

Exclusion Criteria:

• Taking anti-diabetic drugs

• Taking drugs or functional food that may affect blood glucose level

• Fruit allergy

• 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

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

• Glucose Intolerance
• Prediabetes
• Prediabetic State

Intervention

Dietary Supplement:
• Low dose of blueberry dry powder

• High dose of blueberry dry powder

Locations

Country	Name	City	State
Japan	Hiroshima University	Hiroshima

Sponsors (2)

Lead Sponsor	Collaborator
Hiroshima University	Agricultural Producers' Cooperative Corporation Shinpo-en

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
Primary	Change in HbA1c from baseline		Weeks 0 and 12	No
Secondary	Change in glycoalbumin from baseline		Every 6 weeks (Overall 12 weeks)	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 C-peptide from baseline		Weeks 0 and 12	No