Unique ID issued by UMIN | UMIN000032634 |
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Receipt number | R000037162 |
Scientific Title | Randomized, placebo-controlled double-blind, comparative study of Ketonformula in healthy adult volunteers (single dose study) |
Date of disclosure of the study information | 2018/06/30 |
Last modified on | 2019/11/18 16:17:27 |
Randomized, placebo-controlled double-blind, comparative study of Ketonformula in healthy adult volunteers (single dose study)
Single dose study of Ketonformula for standardization of cancer ketogenic diet therapy
Randomized, placebo-controlled double-blind, comparative study of Ketonformula in healthy adult volunteers (single dose study)
Single dose study of Ketonformula for standardization of cancer ketogenic diet therapy
Japan |
Healthy adult
Adult |
Others
NO
To elucidate the pharmacokinetics of blood ketone bodies when single administration of Ketonformula in healthy adult volunteers
PK,PD
plasma concentration of ketone bodies (acetoacetic acid, 3-hydroxybutyrate)
Acetone concentration in breath
plasma concentration of medium chain fatty acids
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Placebo
4
Treatment
Food |
A single serving of the 50g placebo formula
A single serving of the 50g placebo formula and the 25g Ketonformula
A single serving of the 25g placebo formula and the 50g Ketonformula
A single serving of the 75g Ketonformula
20 | years-old | <= |
40 | years-old | >= |
Male
1) Subjects who have given written informed consent
2) Healthy males aged 20 to 40 years old
3) Subjects whose blood test value and urine test value are within the normal range
4) Subjects whose BMI is 18.5 to 25
1) Subjects having a smoking habit
2) Subjects receiving drug treatment
3) Subjects whose blood test value and urine test value are out of the normal range
4) Subjects with gastrointestinal complications
5) Subjects with allergies to milk, soybean, or pork
6) Subjects with lactose intolerance
7) Subjects undergoing carbohydrate restriction or ketogenic diet
8) Any other person whom the principal investigator has determined to be unsuitable as a participant of the study.
24
1st name | Keisuke |
Middle name | |
Last name | Hagihara |
Graduate School of Medicine, Osaka University
Department of Advanced Hybrid Medicine
565-0871
2-2 Yamadaoka, Suita, Osaka 565-0871
06-6210-8349
hagihara.keisuke@gmail.com
1st name | Keisuke |
Middle name | |
Last name | Hagihara |
Graduate School of Medicine, Osaka University
Department of Advanced Hybrid Medicine
565-0871
2-2 Yamadaoka, Suita, Osaka 565-0871
06-6210-8349
hagihara.keisuke@gmail.com
Graduate School of Medicine, Osaka University
Meiji, Co., Ltd., Meiji Seika Pharma, Co., Ltd., The Nisshin OilliO Group, Ltd.
Profit organization
Osaka University Clinical Research Review Committee
2-15, Yamadaoka, Suita, Osaka, Japan
06-6210-8290
rinri@hp-crc.med.osaka-u.jp
NO
2018 | Year | 06 | Month | 30 | Day |
Unpublished
No longer recruiting
2018 | Year | 06 | Month | 27 | Day |
2018 | Year | 06 | Month | 27 | Day |
2018 | Year | 07 | Month | 01 | Day |
2018 | Year | 08 | Month | 11 | Day |
2018 | Year | 09 | Month | 06 | Day |
2019 | Year | 02 | Month | 06 | Day |
2018 | Year | 05 | Month | 18 | Day |
2019 | Year | 11 | Month | 18 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037162
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