Prediabetes
Conditions
Brief summary
This study is designed to evaluate the effect of ume paste and ginger powder on glucose metabolism in prediabetic subjects.
Interventions
DIETARY_SUPPLEMENTPlacebo
DIETARY_SUPPLEMENTUme paste and ginger powder
Sponsors
KAWAMOTO FOODS CO., LTD.
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 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
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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Change in serum total cholesterol from baseline | Every 6 weeks (Overall 12 weeks) | — |
| Change in HbA1c from baseline | Weeks 0 and 12 | — |
| Change in serum HDL cholesterol from baseline | Every 6 weeks (Overall 12 weeks) | — |
| Change in serum triglyceride from baseline | Every 6 weeks (Overall 12 weeks) | — |
| Change in serum LDL cholesterol from baseline | Every 6 weeks (Overall 12 weeks) | — |
| Change in glycoalbumin from baseline | Weeks 0 and 12 | — |
Countries
Japan
Outcome results
None listed