Unique ID issued by UMIN | UMIN000019175 |
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Receipt number | R000022153 |
Scientific Title | Double-Blind, Placebo-Controlled, Parallel Group Comparison Study for the Effect of Daily Ingestion of "Sarasara Gold" extract from onions produced in Hokkaido in the Improvement of Glucose Metabolism |
Date of disclosure of the study information | 2015/09/30 |
Last modified on | 2017/07/21 12:22:30 |
Double-Blind, Placebo-Controlled,
Parallel Group Comparison Study for the Effect of Daily Ingestion of
"Sarasara Gold" extract from onions
produced in Hokkaido in the Improvement of Glucose Metabolism
The Effect of Daily Ingestion of the Onion Extract on the Improvement of Glucose Metabolism
Double-Blind, Placebo-Controlled,
Parallel Group Comparison Study for the Effect of Daily Ingestion of
"Sarasara Gold" extract from onions
produced in Hokkaido in the Improvement of Glucose Metabolism
The Effect of Daily Ingestion of the Onion Extract on the Improvement of Glucose Metabolism
Japan |
Healthy adults
Not applicable | Adult |
Others
NO
To prove the clinical usefulness for improvement in glucose metabolism by investigating effects of daily ingestion of "Sarasara Gold" onion extract for 8 weeks.
Efficacy
Pragmatic
Not applicable
Serum adiponectin at baseline, and at 4 and 8 weeks after ingestion of test meal.
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)
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Placebo
YES
NO
Institution is not considered as adjustment factor.
YES
No need to know
2
Treatment
Food |
Ingestion of capsules containing the onion extract daily for 8 weeks.
Ingestion of placebo capsules daily for 8 weeks.
20 | years-old | <= |
65 | years-old | > |
Male and Female
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.
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.
64
1st name | |
Middle name | |
Last name | Prof. Jun NISHIHIRA, M.D., Ph.D. |
Hokkaido Information University
Department of Medical Management and Informatics
59-2, Nishi-nopporo, Ebetsu, Hokkaido, 069-8585, Japan
011-385-4411
nishihira@do-johodai.ac.jp
1st name | |
Middle name | |
Last name | Dir. Prof. Jun NISHIHIRA, M.D., Ph.D. |
Hokkaido Information University
Health Information Science Center
59-2, Nishi-nopporo, Ebetsu, Hokkaido, 069-8585, Japan
011-385-4430
nishihira@do-johodai.ac.jp
Hokkaido Information University
Amino Up Chemical Co., Ltd.
Profit organization
Japan
NO
北海道情報大学 保健センター(北海道)
2015 | Year | 09 | Month | 30 | Day |
Unpublished
Main results already published
2015 | Year | 09 | Month | 30 | Day |
2015 | Year | 09 | Month | 30 | Day |
2015 | Year | 12 | Month | 12 | Day |
2015 | Year | 12 | Month | 28 | Day |
2016 | Year | 01 | Month | 07 | Day |
2016 | Year | 03 | Month | 10 | Day |
2015 | Year | 09 | Month | 30 | Day |
2017 | Year | 07 | Month | 21 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022153
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