Healthy adults
Conditions
Interventions
Ingestion of capsules containing the onion extract daily for 8 weeks.
Ingestion of placebo capsules daily for 8 weeks.
Sponsors
Hokkaido Information University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subjects whose fasting blood glucose or HbA1c is relatively high. 2. Subjects whose BMI is 18.5 or more and less than 35. 3. Subjects whose blood adiponectin level is relatively low (selected from the screening). 4. Subjects who agree to participate in the current study with a written informed consent.
Exclusion criteria
Exclusion criteria: 1. Subjects who are under treatment, medication and life-style advice for diabetes by doctors. 2. Subjects with serious cerebrovascular, cardiac, hepatic, renal, gastrointestinal, endocrine and metabolic disorders and/or affected with an infectious disease which is required to report to the authorities. 3. Subjects who have a major surgical history related to digestive system such as gastrectomy, gastrorrhaphy, enterectomy and/ or other serious gastrointestinal surgeries. 4. Subjects with abnormal blood pressure or hematological data 5. Subjects with serious anemia 6. Pre- or post-menopausal subjects having complaints of obvious physical changes 7. Subjects who are allergic to foods, especially onions and gelatin. 8. Subjects regularly take medicine, functional foods and/or supplements including dietary fiber such as indigestible dextrin etc., and/or polyphenol, etc. which would affect the blood glucose. 9. Heavy smokers, chronic alcohol drinkers and/or subjects with irregular lifestyle. 10. Subjects who donate either 400ml whole blood within 12 weeks or 200ml whole blood within 4 weeks or blood components within 2 weeks prior to screening. 11. Subjects who are pregnant or expected to be pregnant, or lactating during the study. 12. Subjects who participate in other clinical trials within the last one month prior to the current clinical trial. 13. Any other medical reasons judged by the principal investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Serum adiponectin at baseline, and at 4 and 8 weeks after ingestion of test meal. | — |
Secondary
| Measure | Time frame |
|---|---|
| Fasting blood glucose, HbA1c, glycoalbumin, 1.5-AG, insulin, HOMA-IR, body composition (body weight, BMI, body fat percentage and waist circumference), blood pressure at clinic (SBP and DBP), and QOL questionnaire (VAS) | — |
Countries
Japan
Contacts
Public ContactDir. Prof. Jun NISHIHIRA, M.D., Ph.D.
Hokkaido Information University Health Information Science Center
Outcome results
None listed