Effects of Blueberry Dry Powder on Glycemic Status in Subjects With Prediabetes
A Randomized, Double-blind, Parallel Group Study to Evaluate the Effect of Blueberry Dry Powder on Prediabetes
1 other identifier
interventional
50
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Nov 2013
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2013
CompletedFirst Submitted
Initial submission to the registry
December 17, 2013
CompletedFirst Posted
Study publicly available on registry
December 30, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2014
CompletedAugust 11, 2014
August 1, 2014
8 months
December 17, 2013
August 7, 2014
Conditions
Outcome Measures
Primary Outcomes (3)
Change in fasting plasma glucose from baseline
Every 6 weeks (Overall 12 weeks)
Change in 2h glucose concentration after the oral glucose tolerance test (OGTT) from baseline
Weeks 0 and 12
Change in HbA1c from baseline
Weeks 0 and 12
Secondary Outcomes (4)
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
Change in serum C-peptide from baseline
Weeks 0 and 12
Study Arms (2)
Low dose of blueberry dry powder
EXPERIMENTAL0.5 g blueberry dry powder, twice a day for 12 weeks
High dose of blueberry dry powder
EXPERIMENTAL5.0 g blueberry dry powder, twice a day for 12 weeks
Interventions
Eligibility Criteria
You may qualify if:
- Fasting plasma glucose 110-125 mg/dL
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hiroshima University
Hiroshima, Hiroshima, 734-8551, Japan
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Fumiko Higashikawa, PhD
Hiroshima University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
December 17, 2013
First Posted
December 30, 2013
Study Start
November 1, 2013
Primary Completion
July 1, 2014
Study Completion
July 1, 2014
Last Updated
August 11, 2014
Record last verified: 2014-08