Prediabetes
Conditions
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.
Interventions
DIETARY_SUPPLEMENTLow dose of blueberry dry powder
DIETARY_SUPPLEMENTHigh dose of blueberry dry powder
Sponsors
Agricultural Producers' Cooperative Corporation Shinpo-en
Hiroshima University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 70 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Change in glycoalbumin from baseline | Every 6 weeks (Overall 12 weeks) | — |
| Change in serum C-peptide 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 |
Countries
Japan
Outcome results
None listed