Unique ID issued by UMIN | UMIN000023868 |
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Receipt number | R000027311 |
Scientific Title | Study on health effects of syrup |
Date of disclosure of the study information | 2016/09/01 |
Last modified on | 2017/03/03 11:50:50 |
Study on health effects of syrup
Study on health effects of syrup
Study on health effects of syrup
Study on health effects of syrup
Japan |
Healthy volunteers
Adult |
Others
NO
The aim of this study is to evaluate the effects of a 14-day ingestion 2 types of syrup on biochemical examination of blood, blood RNA, and fecal microflora in a randomized placebo-controlled crossover trial.
Efficacy
Liver function (ALT,AST,gammaGT,ALP,LD,T-Bil)
・Blood RNA analysis
・Fecal (intestinal) mocroflora analysis
Interventional
Cross-over
Randomized
Individual
Single blind -participants are blinded
Placebo
2
Prevention
Food |
Test food (1 pack(15mL)/day) for 14 days > 14-day washout period > control food (1 pack(15mL)/day) for 14 days for 14 days
Control food (1 pack(15mL)/day) for 14 days > 14-day washout period > test food(1 pack(15mL)/day) for 14 days for 14 days
20 | years-old | <= |
70 | years-old | > |
Male and Female
1.Body mass index (BMI): from 23 to less than 30.
2.ALT: 26U/L or more in men, 18U/L or more in women.
3.Volunteers being able to make self-judgent to particupate in this study and giving written informed consent.
4.Volunteers having screening test results judged to be appropriate for this study by investigator.
1.Patients with dyslipidemia or with diabetes under medical treatment or on the use of medicine.
2.Volunteers having severe history of the diseases (liver, kidney, hert, blood) judged to be inappropriate for this study.
3.Patients with liver diseases of alcoholic steatohepatitis, hepatitis C, hepatitis B, autoimmune hepatitis, cirrhosis, or liver cancer, etc. other than non-alcoholic fatty disease.
4.Volunteers received gastrectomy, enterectomy, or gastro-intestinal diseases, judged to be inappropriate for this study.
5.Volunteers with a risk of causing drug or food (especially maple syrup) allergic symptoms.
6.Volunteers with a risk of causing drug or food (especially maple syrup) allergic symptoms.
7.Women who are pregnant, might be pregnant, or are lactating.
8.Volunteers who participate in other clinical trials within the last one month prior to the current clinical trial.
9.Volunteers with any other medical reasons judged to be inappropriate by chief investigater.
10.Volunteers who habitually consume maple syrup.
20
1st name | |
Middle name | |
Last name | Kenichi Watanabe |
Niigata Universty of Pharmacy and Applied Life Sciences
Laboratory of Clinical pharmacology
265-1, Higashijima, Akiha-ku, Niigata City
0250-25-5267
watanabe@nupals.ac.jp
1st name | |
Middle name | |
Last name | Niigata Bio-Research Park, Inc |
Niigata Bio-Research Park, Inc
Business promotion division
316-2 Higashijima, Akiha-ku, Niigata, 956-0811, Japan
0250-25-1196
goto@nbrp.co.jp
Niigata Bio-Research Park, Inc
KANAGAWA ACADEMY OF SCIENCE AND TECHNOLOGY
Non profit foundation
NO
2016 | Year | 09 | Month | 01 | Day |
Unpublished
Completed
2016 | Year | 08 | Month | 05 | Day |
2016 | Year | 09 | Month | 20 | Day |
2016 | Year | 08 | Month | 31 | Day |
2017 | Year | 03 | Month | 03 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027311
Research Plan | |
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Research case data specifications | |
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Research case data | |
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