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

Not Applicable

Completed

• Conditions: Prediabetes
• Interventions: Dietary Supplement: High dose of blueberry dry powder; Dietary Supplement: Low dose of blueberry dry powder

• Registration Number: NCT02023320
• Lead Sponsor: Hiroshima University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-11
• Study First Submitted: 2013-12-17
• Study First Submitted QC: 2013-12-23
• Study First Posted: 2013-12-30
• Primary Completion: 2014-07
• Study Completion: 2014-07
• Status Verified: 2014-08
• Last Update Submitted: 2014-08-07
• Last Update Posted: 2014-08-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
High dose of blueberry dry powder	High dose of blueberry dry powder	5.0 g blueberry dry powder, twice a day for 12 weeks
Low dose of blueberry dry powder	Low dose of blueberry dry powder	0.5 g blueberry dry powder, twice a day for 12 weeks

Primary Outcome Measures

Name	Time	Method
Change in fasting plasma glucose from baseline	Every 6 weeks (Overall 12 weeks)
Change in HbA1c from baseline	Weeks 0 and 12
Change in 2h glucose concentration after the oral glucose tolerance test (OGTT) from baseline	Weeks 0 and 12

Secondary Outcome Measures

Name	Time	Method
Change in serum C-peptide from baseline	Weeks 0 and 12
Change in glycoalbumin from baseline	Every 6 weeks (Overall 12 weeks)
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

Trial Locations

Locations (1)

Hiroshima University; 🇯🇵 Hiroshima, Japan