Unique ID issued by UMIN | UMIN000028824 |
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Receipt number | R000032991 |
Scientific Title | Exploratory test on the influence of kestose intake on lifestyle-related diseases improvement effect |
Date of disclosure of the study information | 2017/08/25 |
Last modified on | 2018/01/15 10:50:23 |
Exploratory test on the influence of kestose intake on lifestyle-related diseases improvement effect
Exploratory test on the influence of kestose intake on lifestyle-related diseases improvement effect
Exploratory test on the influence of kestose intake on lifestyle-related diseases improvement effect
Exploratory test on the influence of kestose intake on lifestyle-related diseases improvement effect
Japan |
Healthy Adults
Not applicable |
Others
NO
Explore the effect of kestose intake on lifestyle-related disease improvement.
Efficacy
Insulin resistance (glucose, HbA1c, insulin, HOMA-IR, AUC, Cmax, C, myoinositol, creatinine) at the beginning of the test or after ingestion of 4, 8 and 12 weeks
Cholesterol (total cholesterol, LDL-cholesterol), blood neutral fat (TG), general blood biochemical test (HDL-cholesterol, AST, ALT, g-GT, urea nitrogen, creatinine , TNF-a, IL-1b, IL-6, IL-10, BDNF), intestinal environment (urine, albumin, total protein, ALP, LD, sodium, chlorine, potassium, calcium, inorganic phosphorus, magnesium, free fatty acid, (indoxyl sulfate, creatinine, short chain fatty acid, intestinal bacteria), stress (IgA), physical examination (body weight, blood pressure, pulse rate, BMI), questionnaire, at the beginning of the test or after ingestion of 4, 8 and 12 weeks
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Placebo
2
Prevention
Food |
Ingest total 10 g of kestose, 5 g each in the morning and the night.
Ingest total 10 g of maltose, 5 g each in the morning and the night.
20 | years-old | <= |
64 | years-old | >= |
Male and Female
1.Persons who received a sufficient explanation of the purpose and contents of the exam, have the capacity to consent, applied with free will with sufficient understanding, and agreed to participate with a written document
2.Healthy Japanese who is 20 years old or more and under 64 years old
3.Persons whose BMI is 23 or more at screening
1.Persons who have a chronic disease and is under medication, or has a serious disease history
2.Persons whose HOMA-IR at screening is 2.5 or more
3.Persons whose fasting blood glucose level at screening is 126 mg/dL or more
4.Persons whose LDL cholesterol at screening is 140 mg/dL or more
5.Persons whose blood neutral fat at screening is 150 mg/dL or more
6.Persons who are allergic to the test food
7.Persons who participated in other examination during the first month before the start of the exam, or those who plan to participate in other exams following this exam agreement
8.Persons who are breastfeeding, pregnant, scheduled or hoping to be pregnant during the exam period
9.Persons who are judged inappropriate for the exam by the principal investigator
60
1st name | |
Middle name | |
Last name | Hirohito Ishikawa |
Healthcare Systems Co., Ltd.
Research and Development
Nisshin Tatemono Shinbashi Bld. 7F, 4-6-15 Shinbashi, Minato-ku, Tokyo, JAPAN
0368092722
ishikawa@hc-sys.jp
1st name | |
Middle name | |
Last name | Hirohito Ishikawa |
Healthcare Systems Co., Ltd.
Research and Development
Nisshin Tatemono Shinbashi Bld. 7F, 4-6-15 Shinbashi, Minato-ku, Tokyo, JAPAN
0368092722
ishikawa@hc-sys.jp
Healthcare Systems Co., Ltd.
B Food Science Co., Ltd.
Profit organization
NO
2017 | Year | 08 | Month | 25 | Day |
Unpublished
Completed
2017 | Year | 07 | Month | 22 | Day |
2017 | Year | 09 | Month | 02 | Day |
2018 | Year | 01 | Month | 13 | Day |
2017 | Year | 08 | Month | 25 | Day |
2018 | Year | 01 | Month | 15 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032991
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